LE PONT-DE-CLAIX, France, Sept. 18, 2024 /PRNewswire/ -- BD (Becton, Dickinson and Company) (NYSE: BDX)
a leading global medical technology company
announced the commercial release of the BD Neopak™ XtraFlow™ Glass Prefillable Syringe and the latest capacity expansion of the BD Neopak™ Glass Prefillable Syringe platform to serve the growing market for biologic therapies
The BD Neopak™ Glass Prefillable Syringe platform is designed to address key development needs for biologic drugs and our customers have received approval to utilize this platform for more than 24 indications
cardiovascular disease and various rare diseases
BD has expanded usability of this platform with the commercial release of the BD Neopak™ XtraFlow™ Glass Prefillable Syringe
This solution features an 8-millimeter needle length and thinner wall cannula to optimize subcutaneous delivery of higher viscosity drug profiles by reducing the injection force and time required for a fixed solution viscosity1,2*
This improvement allows pharmaceutical developers to break design barriers
enhancing flow and usability beyond today's limits versus a standard half-inch needle3*
"BD is seeing significant growth in the biologics segment
driven by novel drug formulations across indications such as metabolic disorders and oncology," said Patrick Jeukenne
"With over 30 drugs approved across 12 markets and many more in development with the BD Neopak™ Glass Prefillable Syringe platform
As a global leader in prefillable drug-delivery systems
BD aims to evolve as rapidly as the global biologics pipeline to enable supply and delivery of these drugs for patients worldwide."
our manufacturing site in Le Pont-de-Claix
France has successfully integrated a high-volume manufacturing line for the BD Neopak™ Glass Prefillable Syringe platform
increasing the production capacity of a single line by sevenfold4
This achievement marks a significant milestone for BD
enabling unprecedented large-scale production of advanced BD glass syringes
The launch of our BD Neopak™ XtraFlow™ Glass Prefillable Syringe allows developers to take advantage of a single platform approach while dismantling existing design barriers such as drug viscosity
The successful addition of the high-volume line at the Pont-de-Claix site allows BD to be more resilient to supply constraints and further demonstrates our commitment to continuously evolve to meet the needs of our pharmaceutical partners and patients worldwide
These expansions add to BD's leadership in offering a broad range of injection solutions to enable delivery of treatments such as GLP-1s
and other next generation treatments for chronic disease
This press release contains certain forward-looking statements regarding the BD Neopak™ Glass Prefillable Syringe platform
Forward-looking statements involve risks and uncertainties that could cause actual results to differ materially from those expressed or implied in such statements
challenges inherent in product development
including the development of new technologies or products by other companies
or other factors listed in BD's 2023 Annual Report on Form 10-K and other filings with the SEC
BD expressly disclaims any undertaking to update any forward-looking statements set forth herein to reflect events or circumstances after the date hereof
except as required by applicable laws or regulations
Media:
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Public Relations
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Injection time and ejection force calculation [internal study]
BD NeopakTM XtraFlowTM 2.25 mL prototype evaluation [internal study]
3. Pager et al. (2020), "User experience for manual injection of 2 mL viscous solutions is enhanced by a new prefillable syringe with staked 8 mm ultra-thin wall needle", Expert Opinion on Drug Delivery, https://doi.org/10.1080/17425247.2020.1796630
*When compared to 12.7 mm special thin wall needle
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announced a strategic collaboration with Ypsomed
to advance self-injection solutions for high-viscosity biologic drugs
Ypsomed and BD have pre-assessed and streamlined integration of the BD Neopak™ XtraFlow™ Glass Prefillable Syringe with Ypsomed’s YpsoMate® 2.25 autoinjector platform
addressing current limitations by enabling the delivery of higher viscosity (>15cP) biologic drugs in an autoinjector format
The BD Neopak™ XtraFlow™ Glass Prefillable Syringe is BD’s latest portfolio addition
and thinner wall cannula to optimize subcutaneous delivery of higher viscosity drug profiles
enhancing flow and usability beyond today’s limits versus a standard half-inch needle1,2* This solution is a part of the BD Neopak™ Glass Prefillable Syringe Platform
which is designed to address key development needs for biologic drugs
Ypsomed is expanding its YpsoMate® 2.25 two-step autoinjector platform to accommodate the new syringe format
This includes adapting parts of the autoinjector for the shorter needle
and performing extensive technical testing to ensure reliability
The YpsoMate autoinjector device is handled in two steps: simply remove the cap and push on skin
designed so that people with impaired grip or vision can administer their medication easily and safely
Supporting our pharmaceutical partners to de-risk and accelerate combination product development
“We are excited to welcome the first pharmaceutical customers to experience the benefits of the BD Neopak™ XtraFlow™ Glass Prefillable Syringe with the YpsoMate® 2.25 autoinjector,” said Ulrike Bauer
Chief Business Officer of Ypsomed Delivery Systems
“This collaboration underscores our commitment to enhancing patient care through innovative drug delivery solutions.”
“Cross-supplier collaborations are vital in today’s pharmaceutical ecosystem,” said Patrick Jeukenne
worldwide president of BD Pharmaceutical Systems
“These partnerships can help drive innovation and ensure that systems work by design and over lifecycles
allowing our pharmaceutical partners to get life-saving therapies to patients faster.”
BD and Ypsomed are key leaders in drug delivery
enabling the administration of chronic condition therapeutics such as GLP-1s
Combining BD’s robust syringe platform technology with Ypsomed’s leading autoinjector platform
this collaboration leverages shared expertise to deliver reliable device systems
“User experience for manual injection of 2 mL viscous solutions is enhanced by a new prefillable syringe with staked 8 mm ultra-thin wall needle”
https://doi.org/10.1080/17425247.2020.1796630
YpsoMate is a registered trademark of Ypsomed AG
BD and the BD Logo are trademarks of Becton
All other trademarks are the property of their respective owners
All Blog Posts ›
has announced the commercial release of the BD Neopak XtraFlow Glass Prefillable Syringe and the latest capacity expansion of the BD Neopak Glass Prefillable Syringe platform to serve the growing market for biologic therapies
The BD Neopak Glass Prefillable Syringe platform is designed to address key development needs for biologic drugs and customers have received approval to utilise this platform for more than 24 indications
BD has expanded usability of this platform with the commercial release of the BD Neopak XtraFlow Glass Prefillable Syringe
This solution features an 8-millimeter needle length and thinner wall cannula to optimize subcutaneous delivery of higher viscosity drug profiles by reducing the injection force and time required for a fixed solution viscosity
enhancing flow and usability beyond today's limits versus a standard half-inch needle
BD's manufacturing site in Le Pont-de-Claix, France has successfully integrated a high-volume manufacturing line for the BD Neopak Glass Prefillable Syringe platform
increasing the production capacity of a single line by sevenfold
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Built on the Grands Moulins de Villancourt heritage site in France
the contemporary Centre de sciences Cosmocité aims to be the cultural cornerstone of Ville de Pont-de-Claix’s urban renewal
Architects Jean-Yves Guibourdenche and Jean-François Julien have unveiled their design for the new Centre de sciences Cosmocité, which has opened in Pont-de-Claix, a commune in the Isère department in southeastern France
In line with the museum concept developed by scenographer CREO
and in close collaboration with cultural centre La Casemate and the wider scientific community
the building aims to preserve the memory of the Grands Moulins de Villancourt site
an important part of the municipalities of Echirolles and Pont-de-Claix in the 19th and 20th centuries
Taking up the exact layout of the demolished building
the architects created two distinct volumes – one rectangular white volume and a sweeping
black curve – link the region’s industrial past with the contemporary scientific focus of the new institution
The glossy white section of the building houses the passageways and related spaces, while the centre’s opaque black volume houses spaces dedicated to the dissemination of scientific content: the planetarium
immersion room and permanent exhibition hall
Finding inspiration in the universe’s great mysteries and humankind’s place in the cosmos
and mysterious quality invites onlookers to reflect
the vertical and horizontal corridors are bathed in natural light
and offer views of the surrounding landscape
the circular planetarium is inclined at 10°
including 4 for people with reduced mobility
and provides a 360° view of a semi-spherical screen
The architectural team called on the Montreal-based digital studio CREO to create the Cosmocité scenography
To meet the numerous requirements of this ambitious project
CREO put together a multidisciplinary design team
who worked in close collaboration with the project’s Grenoble-based scientific committee
as well as with Centre de Culture Scientifique
Cosmocité’s highly interactive exhibition is designed to answer fundamental questions such as: Is the Earth unique
from the birth of stars to the causes of earthquakes
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Volume 9 - 2018 | https://doi.org/10.3389/fimmu.2018.03034
CD9 was recently identified as a marker of murine IL-10-competent regulatory B cells
Functional impairments or defects in CD9+ IL-10-secreting regulatory B cells are associated with enhanced asthma-like inflammation and airway hyperresponsiveness
all asthma-related features can be abrogated by CD9+ B cell adoptive transfer
and molecular mechanisms of the regulatory properties of CD9+ B cells in human and mouse
The profile of CD9+ B cells was analyzed using blood from severe asthmatic patients and normal and asthmatic mice by flow cytometry
The regulatory effects of mouse CD9+ B cells on effector T cell death
and mitochondrial depolarization were determined using yellow dye
MAPK phosphorylation was analyzed by western blotting
Patients with severe asthma and asthmatic mice both harbored less CD19+CD9+ B cells
although these cells displayed no defect in their capacity to induce T cell apoptosis
Molecular mechanisms of regulation of CD9+ B cells characterized in mouse showed that they induced effector T cell cycle arrest in sub G0/G1
leading to apoptosis in an IL-10-dependent manner
This process occurred through MAPK phosphorylation and activation of both the intrinsic and extrinsic pathways
This study characterizes the molecular mechanisms underlying the regulation of CD9+ B cells to induce effector T cell apoptosis in mice and humans via IL-10 secretion
Defects in CD9+ B cells in blood from patients with severe asthma reveal new insights into the lack of regulation of inflammation in these patients
and CD9 thus appears to be a reliable marker for defining both mouse and human Bregs
that mouse and human CD9+ B cells elicit regulatory properties through IL-10 secretion
and transitional CD24hiCD38hiB cells expressing CD9 are decreased in the blood of severe asthmatic patients
We report that CD9+ B cells induce effector T cell apoptosis via the secretion of IL-10
T cell proliferation is blocked at the sub G0/G1 cell cycle phase
leading to activation of the intrinsic and extrinsic apoptotic pathways via a MAPK-dependent mechanism
These data reveal new insights on the lack of regulation of inflammation in severe asthmatic patients and help pave the way to the discovery of potential novel therapies
Peripheral blood mononuclear cells (PBMCs) were isolated by Ficoll-Paque (GE Healthcare
France) gradient centrifugation and frozen
Immunophenotyping of PBMCs from 9 severe asthmatic patients was performed using flow cytometry
PBMCs from 10 HV were analyzed as controls
PBMCs were rapidly thawed by placing cryovials at 37°C
washed and stained according to standard protocols using the following mAbs: CD19-BUV395
These markers were used to distinguish CD19+ B lymphocytes
CD19+CD27− naïve cells
CD19+CD24−CD38+ plasma cells
dead cells were excluded using the Zombie NIR™ Fixable Viability kit (BioLegend
Human anti–IL-10 (BD Biosciences) was used to inhibit the IL-10 pathway
Samples were assessed on a BD LSRFORTESSA X-20 (BD Biosciences
and the data were analyzed using FlowJo v10 software (FlowJo LLC
Six week-old wild-type BALB/c mice were purchased from Charles River Laboratories (Ecully, France). Allergic inflammation was induced using a total House Dust Mite (HDM) extract (Dermatophagoïdes farinae) provided by Stallergenes (Antony, France), as previously described (31)
This study was performed in accordance with the recommendations of the Regional Ethical Committee for Animal Experiments of Pays de la Loire (ceea.2012.77) under accreditation number 3455
The protocol was approved by the Regional Ethical Committee for Animal Experiments of Pays de la Loire
Six week-old wild-type BALB/c mice were purchased from Charles River Laboratories (Ecully
Splenic cells were isolated and stained with the following antibodies for cell sorting by flow cytometry: CD19-APC-H7 (1D3)
These markers were used to distinguish CD19+CD9− non-regulatory B cells
CD19+CD9+ Breg cells and CD3+CD4+CD25− effector T cells
Cells were sorted on a BD FACSARIA III (BD Biosciences
Mouse cells (1 million/mL) were cultured for 48 h in RPMI-1640 medium with 10% fetal calf serum and 2 mM glutamine
CD19+CD9− non-regulatory B cells or CD19+CD9+ Breg cells were activated with 2 μg/mL anti-CD40 (HM40-3) (BD Biosciences
France) for 48 h and 10 μg/mL LPS for 5 h
CD3+CD4+CD25− effector T cells were activated with 100 U/mL interleukin-2 (IL-2) for 48 h
Effector T cells were then co-cultured for 48 h with non-regulatory or Breg cells at a ratio of 1:1 and at a concentration of 1 million/ml on plates coated with anti-CD3 (145-2C11) (BD Biosciences
the same protocol was used except that B cells were activated with 50 ng/mL recombinant human soluble CD40L (R&D Systems Europe
France) plus 2.5 mg/mL CpG oligodeoxynucleotide 2006 (InvivoGen
and T cells were activated with 50 U/mL recombinant IL-2 (SARL Pharmaxie
the cells were treated with 50 nM Z-VAD (R&D Systems Europe
To inhibit IL-10 and the transforming growth factor-beta (TGF-β) and Fas pathways
the cells were treated during co-culture with 10 μg/mL anti–IL-10 (BD Biosciences
10 μg/mL anti–TGF-β1 (Abcam
or 20 μg/mL anti-Fas ligand (R&D Systems Europe
the cells were treated during co-culture with 0.2 μg/μL KMC8 monoclonal antibody (BD Biosciences
the cells were treated with 10 ng/mL recombinant IL-10 (R&D Systems Europe
To determine the percentage of dead CD3+CD4+CD25− effector T cells
the cells were stained using a LIVE/DEAD Fixable Yellow Dead Cell Stain Kit according to the manufacturer's recommendation (Invitrogen
B cells were removed from the analysis using a gating strategy based on CD19-APC-H7 (1D3) staining
T cell cycle stages were assessed using propidium iodide (PI) staining (Beckman Coulter
France) and the percentage of apoptotic T cells by Annexin V-FITC staining (BD Biosciences
Samples were run on a BD LSRFORTESSA X-20 (BD Biosciences
The analysis of CD3+CD4+CD25− effector T cells protein expression was performed by western blotting after negative selection with MACS columns (Miltenyi Biotec
The following primary antibodies were used: anti-Bid
Mitochondrial membrane potential was measured using the potential-sensitive fluorescent probe tetraethylbenzimidazolylcarbocyanine iodide (JC-1) (Life Technologies
Cells were incubated in Hank's Balanced Salt Solution (Gibco Life Technologies
France) with JC-1 at 5 mg/mL for 30 min at 37°C
CD19-APC-H7 (1D3) antibody staining allowed the removal of B cells from the analysis
cells were stained with the following Phosflow antibodies: anti-phospho-p38-PeCy-7 and anti-phospho-JNK-PE (BD Biosciences
France); anti-phospho-ERK1/2-PE (eBioscience
France); and CD19-APC-H7 (1D3) antibody to remove B cells from the analysis
Comparisons of experimental values between the two groups were analyzed using the Mann–Whitney U-test
The non-parametric Kruskal–Wallis test with Dunn's posttest were used for comparisons between more than two groups
All statistical analyses were performed using GraphPad Prism v7 (La Jolla
showing that CD19+CD24hiCD38hi transitional cells were included in the CD9+ B cell subset
B lymphocyte subpopulations in the blood of severe asthmatic patients
(A) Gating strategy used after immunostaining to determine all B cell subsets
and CD9+ B cells in 10 healthy volunteers (HV) and 9 severe asthmatic patients (SA) (*p < 0.05
(C) Expression of the mean fluorescence intensity of CD9 in transitional and non-transitional B cell subsets (***p < 0.001)
Asthmatic mice had significantly fewer CD19+CD9+ B cells in the spleen and lung than control mice (4.5% ± 0.3 and 3.1% ± 0.2 vs
7.8% ± 0.7 and 6.8% ± 1 in the spleen and lung of asthmatic and control mice
These data validate the mouse as a relevant model for asthma in humans
we report that patients with severe asthma and asthmatic mice both harbor a defect in number of CD19+CD9+ B cells
Percentage and regulatory properties of CD9+ B cells in asthmatic mice
(A) Induction protocol in asthma mice: House dust mite model
(B) Percentage of CD9+ B cells among CD19+ cells in the spleen and lung of control and asthmatic mice (n = 4
(C) Gating strategy used to remove B cells from the analysis by CD4 FITC staining
splenic CD3+CD4+CD25− effector T cells from asthmatic and naive Balb-c mice were co-cultured for 48 h with CD19+CD9+ or CD19+CD9− B cells or alone as controls
Cells were stained with yellow dye to measure T cell death induced by CD9+ or CD9− B cells
Percentage of Annexin V-positive T cell staining (n = 6
(E) Percentage of T cell death induction by CD19+CD9+ or CD19+CD9− B cells (ns
CD19+CD9− B cells from asthmatic mice or controls did not induce CD3+CD4+CD25− effector T cell death (0.8% ± 5.9 vs
0.4% ± 2.6 in control and asthmatic mice
These data show that although asthmatic mice have reduced number of CD19+CD9+ B cells
these cells display no defects in their capacity to induce T cell apoptosis
Although CD9 has been identified as a marker of B cells that are secreting IL-10
their full regulatory mechanisms remain unknown
Because there was no difference in function between CD19+CD9+ from naïve and asthmatic mouse
we further investigated the regulatory properties of these cells to decipher the molecular pathway leading to T cell death in naïve mice
No difference was observed when T cells were co-cultured with or without CD19+CD9− B cells
CD3+CD4+CD25− effector T cell S-phase progression did not appear to be significantly altered under any of the conditions
showing that B cells had no effect on T cell proliferation per se
these data show that CD19+CD9+ B cells
induce CD3+CD4+CD25− effector T cell cycle arrest in sub G0/G1
Effects of CD9+/− B cells on T cell proliferation and death
splenic CD3+CD4+CD25− effector T cells from Balb-c mice were co-cultured for 48 h with CD19+CD9+ or CD19+CD9− B cells at a 1:1 ratio or alone as controls
Cells were stained with CD4 FITC antibody to remove B cells from the analysis
(A) Cells were stained with propidium iodide to measure T cell cycle stages
Representative staining of the different cell cycle stages
(B) Percentage of T cells in the different cell cycle stages (n = 6)
Treatment with an anti-CD9 agonist had no effect on the T cell death induced by CD19+CD9+ B cells
showing that this effect was not mediated by CD9 (50.3% ± 4.6; ns compared with T cells co-cultured with CD19+CD9+ B cells)
a specific inhibitor of apoptotic cell death
blocked the T cell apoptosis induced by CD19+CD9+ B cells (18.8% ± 5.6; p < 0.01)
these data show that CD19+CD9+ B cells induce CD3+CD4+CD25− effector T cell cycle arrest in sub G0/G1
Effects of CD9+/− B cells on T cell apoptosis
splenic CD3+CD4+CD25− effector T cells from Balb-c mice were co-cultured for 48 h with CD19+CD9+ or CD19+CD9− B cells or alone as controls
the cells were also treated with 2 μg/μL KMC8 anti-CD9 antibody
10 μg/mL anti–TGF-β1
Cells were also co-cultured in trans-wells
The cells were stained with CD4 antibody to remove B cells from the analysis and with Annexin V to measure T cell apoptosis
(A) Representative results of Annexin V staining
(B,C) Percentage of Annexin V-positive T cells in each co-culture condition (n = 6
CD3+CD4+CD25− effector T cells from 9 healthy volunteers were co-cultured for 48 h with CD19+CD9+ or CD19+CD9− B cells or alone as controls
Cells were also treated with 20 μg/mL anti–IL-10 and stained with CD4 antibody to remove B cells from the analysis and stained with Annexin V to measure T cell apoptosis
Percentage of Annexin V-positive T cells in the different co-culture conditions (n = 9; *p < 0.05)
To determine whether direct B cell-T cell contact was necessary for CD19+CD9+ B cells to induce T cell apoptosis, CD3+CD4+CD25− effector T cells were co-cultured with CD19+CD9+ B cells in classical or trans-well plate assays (Figure 4C)
CD19+CD9+ B cells induced T cell death in both situations (44% ± 4.1 vs
the T cell death induced by CD19+CD9+ B cells was not affected when the co-culture was performed in the presence of anti-TGF-β (40% ± 2 vs
33.8% ± 3.6 with or without anti-TGF-β
ns) nor anti-Fas ligand (45% ± 5.1
ns compared with T cells co-cultured with CD19+CD9+ B cells)
anti-IL-10 prevented T cell death and fully restored T cell viability (17.2% ± 1.9 vs
17.6% ± 4.1 for T cells alone and T cells co-cultured with CD19+CD9+ B cells/anti-IL-10
CD3+CD4+CD25− effector T cells treated with IL-10 underwent apoptosis (35% ± 3.4 p < 0.05 compared with T cells alone)
confirming its involvement in T cell apoptosis induced by CD19+CD9+ B cells
these data show that T cell-B cell contact is not necessary for T cell apoptosis induction by CD19+CD9+ B cells and that apoptosis induction is dependent on IL-10
induced apoptosis of T cells (2.8% ± 0.8 for T cells alone
14.3% ± 1.7 for T cells co-cultured with CD19+CD9− B cells
and 21.4% ± 2.7 for T cells co-cultured with CD19+CD9+ B cells; T cells alone vs
T cells co-cultured with CD19+CD9+ B cells
Treatment with anti-IL-10 reduced apoptosis induced by human T cells (15.7% ± 1.1; T cells alone vs
T cells co-cultured with CD19+CD9+ B cells/anti-IL-10
human CD19+CD9+ B cells induce CD3+CD4+CD25− effector T cell apoptosis via IL-10
these data show that CD19+CD9+ B cells induce CD3+CD4+CD25− effector T cell apoptosis via both extrinsic and intrinsic pathways through MAPK activation
Effects of CD9+ B cells on MAPK phosphorylation
Bid and caspase cleavage and mitochondrial depolarization
splenic CD3+CD4+CD25− effector T cells from Balb-c mice were co-cultured for 48 h with CD19+CD9+
CD19+CD9− B cells or alone as controls
(A) B cells were removed from the analysis by CD4 staining
and ERK1/2 in CD3+CD4+CD25− effector T cells was assessed by flow cytometry
(B) CD3+CD4+CD25− effector T cells were negatively selected using MACS columns
and the ratios of cleaved/pro-caspases were calculated
(C) CD3+CD4+CD25− effector T cells were negatively selected by MACS columns
Bid cleavage was assessed by western blotting
(D) Mitochondrial depolarization was assessed by JC-1 staining
Representative results of JC-1 staining and percentage of monomeric JC-1 cells in all culture conditions (n = 5
The ability of Bregs to normalize lung function and airway inflammation and the notable alterations of this Breg pool in asthmatic mice clearly point to these cells as an interesting target in allergic diseases
We demonstrated that these cells regulate effector T cell proliferation
but the mechanisms responsible for such an effect remain unknown
we demonstrated that CD9+ B cells harbored strong suppressive properties
These cells induced the death of effector T cells via the intrinsic and extrinsic pathways of apoptosis in an IL-10-dependent manner and through the MAPK cascade
in humans and reported that severe asthmatic patients have reduced number of CD9+ B cells with regulatory properties
these data not only clearly support CD9 as a potential biomarker of Bregs but also suggest a possible role in asthma physiopathology
differing from the classical role of B cells as IgE producers
no mechanism of action has yet been reported for CD9+ B cells
These cells did not induce cleavage of caspase 12
which is characteristic of endoplasmic reticulum stress
as treatment with necrostatin-1 did not abrogate T cell death (data not shown)
we report that the number of CD9+ B cells was reduced in the blood of severe asthmatic patients
as demonstrated in asthmatic mice lacking CD9+ B cells but displaying no functional defect
these cells were able to induce effector T cell apoptosis in the same manner as CD9+ B cells from wild type mice
our data are the first to characterize the molecular mechanisms of the regulation of CD9+ B cells to induce effector T cell apoptosis in mice and humans
The lack of CD9+ Breg cells in severe asthmatic patients suggests Bregs as a potential target for future therapeutic strategies
A better understanding of the immunological mechanisms underlying allergic diseases is essential for the development of new preventive and therapeutic Breg interventions
and AM: analysis and interpretation of data
All authors critical revision for important intellectual content
All authors approved the final version of the manuscript prior to submission
This work was supported by a grant from l'Institut de Recherche en Santé Respiratoire-Pays de la Loire
This work was achieved in the context of the BASAL project financed by Région Pays de la Loire and the IHU-Cesti project
the DHU Oncogreffe and the LabEX IGO thanks to French government financial support managed by the National Research Agency via the Investment into the Future program (ANR-10-IBHU-005 and ANR-11- LABX-0016-01)
The IHU-Cesti project is also supported by Nantes Métropole and Région Pays de la Loire
The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest
We thank the participating patients and their families
and cooperation were essential for the collection of the data used in this study
We also thank the main EXPRESA investigators: Pr
We also thank the pulmonology team of CIC-Thorax (Megguy Bernard
and Annick Joly) for the EXPRESA follow-up
Haro from the Cytocell Cytometry Facility in Nantes (SFR Bonamy)
and the Unité Thérapeutique Expérimentale in Nantes for the animal experimentation facility
The Supplementary Material for this article can be found online at: https://www.frontiersin.org/articles/10.3389/fimmu.2018.03034/full#supplementary-material
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trigger the development of regulatory B cells
Pathogen-derived immunomodulatory molecules: future immunotherapeutics
Amelioration of allergic airway inflammation in mice by regulatory IL-35 through dampening inflammatory dendritic cells
Unique B cell differentiation profile in tolerant kidney transplant patients
expanding diversity and common goal ofregulatory T and B cells
Magnan A and Brouard S (2018) CD9+ Regulatory B Cells Induce T Cell Apoptosis via IL-10 and Are Reduced in Severe Asthmatic Patients
Received: 28 August 2018; Accepted: 07 December 2018; Published: 21 December 2018
Copyright © 2018 Brosseau, Durand, Colas, Durand, Foureau, Cheminant, Bouchaud, Castan, Klein, Magnan and Brouard. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY)
distribution or reproduction in other forums is permitted
provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited
in accordance with accepted academic practice
distribution or reproduction is permitted which does not comply with these terms
*Correspondence: Sophie Brouard, c29waGllLmJyb3VhcmRAdW5pdi1uYW50ZXMuZnI=
†These authors have contributed equally to this work
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Drug Delivery Business
November 16, 2021 By Sean Whooley
BD (NYSE:BDX) announced today that it broke ground on its $200 million pre-filled drug delivery device manufacturing plant in Spain
Franklin Lakes, New Jersey-based BD announced in May that it would build the $201.5 million (€165 million) high-tech manufacturing facility in Zaragoza, Spain
with expectations of creating up to 600 jobs at the facility by 2030
which will initially register a size of 86,000 square feet (8,000 square meters)
with BD beginning the recruitment process to fill key positions supporting the design and set-up of the plant
“These roles will be on the front lines of building a sustainable, state-of-the-art and fully digital site incorporating the latest in intelligent and autonomous solutions,” Thibault Naegelen, Program Director for BD’s Zaragoza facility, said in the release
“We look forward to building a team in Zaragoza that helps BD meet its mission of advancing the world of health by supplying our European customers with devices that enhance drug delivery.”
In December 2020, BD announced its intent to invest $1.2 billion over four years to expand and upgrade multiple drug-delivery facilities
The company said it would open the new facility and build upon its six existing sites in Columbus
The Zaragoza team will produce drug delivery devices
mainly for biopharmaceutical companies supporting the European market with drugs in pre-fillable syringes
including vaccines and other biologic drugs
BD said the new facility will add much-needed capacity to support major vaccination campaigns going forward
including the ongoing effort to vaccinate the world against COVID-19
The company is set to hire operators and production staff to oversee production lines closer to the opening date for the plant in 2023
BD intends to ensure that the site meets high sustainability and eco-efficiency standards and anticipates that the facility will employ up to 600 people with an area of 323,000 square feet (30,000 square meters) by 2030
“Pre-fillable drug systems are a known factor in helping health care providers effectively
reliably and consistently administer drug therapies,” BD Pharmaceutical Systems Worldwide President Eric Borin said
more than 70% of the top 100 biopharmaceutical companies rely on BD pre-fillable syringes
This groundbreaking marks an important milestone in our ability to extend manufacturing capacity for our customers as they continue to grow their vaccine and biologic drug pipelines.”
Sean Whooley is an associate editor who mainly produces work for MassDevice, Medical Design & Outsourcing and Drug Delivery Business News. He received a bachelor's degree in multiplatform journalism from the University of Maryland, College Park. You can connect with him on LinkedIn or email him at swhooley@wtwhmedia.com
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The architectural consortium comprised of ARCANE Architectes (France) and Cardin Julien (Canada) is delighted to unveil the new Centre de sciences Cosmocité
built on the Grands Moulins de Villancourt heritage site in Pont-de-Claix
conceived by architects Jean-Yves Guibourdenche and Jean-François Julien
is in line with the museum concept developed by scenographer CREO
in close collaboration with La Casemate and the scientific community
Cosmocité aims to preserve the industrial memory of the Grands Moulins de Villancourt site
which was an important part of the industrial and human heritage of the urban agglomeration and the municipalities of Echirolles and Pont-de-Claix in the 19th and 20th centuries
With its location at the municipality's northern entrance
Cosmocité is the cultural cornerstone of Ville de Pont-de-Claix's urban renewal
The commissionTaking up the exact placement layout of the demolished building
the architects created an assemblage of volumes that link the region's industrial past
with the contemporary scientific focus of the new institution embodied by the black volume
glossy white volume houses the passageways and related spaces
while the matte and opaque black volume houses all spaces dedicated to the dissemination of scientific content: the planetarium
Recalling the universe's great mysteries and humankind's place in the cosmos
and mysterious quality invites onlookers to fathom its scale
The volumetric design reflects the building's function and contributes to the site's global message: science that's welcoming and open to all
The programCosmocité houses:- An 80-seat planetarium
The role of a planetarium is to teach and popularize astronomy and space science for both school and family audiences.- A permanent tour based on two themes: “EARTH” and “COSMOS”
with interactive floor and wall screens- A 14-metre-high Foucault pendulum- A variable activity space: children/youth audience area and a modular room- Additional facilities: reception
and logistics- A roof terrace overlooking the Grenoble basin and its surrounding mountains- The facility is designed to welcome around 57,000 visitors per year
The planetariumCircular and inclined at 10°
the space can be accessed via a vision adaptation waiting area and an acoustic airlock
providing a 360° view of a semi-spherical screen
It is lined with a circular technical gallery and a data centre
The permanent exhibitionThe architectural team called on the Montreal-based digital studio CREO to create the Cosmocité scenography
who worked in close collaboration with the project's Grenoble-based scientific committee
Cosmocité's highly interactive exhibition is designed to answer fundamental questions such as: Is the Earth unique
it covers everything from the birth of stars to the causes of earthquakes
a 14-metre-high Foucault pendulum spans the building to demonstrate the Earth's rotation
A bioclimatic designThe building has been designed to balance the space of the west-facing garden with that of the eastern forecourt
The hall and staircase are glazed to capture free energy from the sun
and to encourage the public to use the staircase to climb to the upper floors
this solar energy is controlled by screen-printed glass to prevent overheating
the building opens onto the garden and the Vercors landscape
while the cantilevered planetarium hall shelters it from the summer sun
Interior characteristicsThe acoustic comfort has been carefully studied to avoid any sound transfer between spaces
Summer thermal comfort is ensured by:- A heat inert cement structure;- Efficient solar protection: 50% screen-printed glass on the east facade
and external solar shading;- Openings for natural ventilation;- Air quality is ensured by a double-flow system
Energy optimizationEnergy efficiency is primarily about reducing the building's thermal requirements
which is made possible via a compact construction and a high-performance envelope
The building's main structure is in reinforced concrete
which is insulated from the outside to eliminate thermal bridges and the associated risk of condensation
and to benefit from an inertia conducive to summer comfort
The building envelope's performance has been designed to be well below the French regulatory threshold in terms of energy requirements
Heating is provided by way of a district heating system
an urban stone forecourt accommodates the varying flow of visitors drawn to this site and its activities
a garden and its outdoor amphithéâtre form a buffer zone between the parking lots and the Centre de sciences
a conserved hundred-year-old cedar tree serves as a reminder of the city's continuing renewal
Direction/cultural and scientific programming: La Casemate Scientific curator: UGA / CNRS / OSUG
Construction cost: 6 732 000 € HT Architecture ARCANE Architectes and Cardin Julien Engineering Mechanical-electrical engineering: CET Bâtiment & Energie [AK1] [ÉP2] Structural and economy: BETREC I.G
Scenography CREO François Tourny (engineer)
Specialists Immersive room and Planetarium: RSA Cosmos / Theoriz Environmental quality: Etamine Road works and various networks: MTM Infra Acoustics: Echologos
ARCANE Architectes is a resolutely generalist firm
with the ability to respond to operations on all scales in both the private and public sectors
Based in Grenoble since its founding in 1986
its strength resides in its talented and creative team
which supports its clients at every stage of the building process
Backed by a wealth of experience in both new construction and restoration
the firm is renowned for its rigorous approach to deadlines
Each project is conceived as a unique adventure driven by creativity and innovation
and always carried out in a sustainable and resource-efficient manner
Among ARCANE's finest achievements are the Palais des Sports et des Congrès in Megève (France
the Centre de sciences Cosmocité in Le-Pont-Claix (France
and the Arboréa multiple-unit dwelling program in Pringy (France)
for which it was awarded the Grand Prix Régional des Pyramides d'Argent 2022
About Cardin JulienFounded in Montreal in 1992
Cardin Julien is an architecture firm that conceives and produces major projects in the public and private sectors
The firm specializes in the design of public and cultural buildings serving the community
Guided by the principles of sustainable development
the group proposes distinctive designs that are in harmony with their surroundings
the firm aims to leave an impression on both minds and hearts
Following its success in several architectural competitions
Cardin Julien has carried out several major cultural projects
such as the Rio Tinto Alcan Planetarium in Montreal (with Aedifica)
the Planétarium du Jardin des sciences at Université de Strasbourg (with frenak+jullien and m+ mathieu holdrinet)
and Centre de sciences Cosmocité in Grenoble (with ARCANE Architectes).Cardin Julien's mission is to co-create to reveal the full potential of your ideas
and to build places for better living.Media contacts France Amandine Kowalskiamandine.kowalski@arcane-archi.frTel: + (33) 4 76 03 27 27
Canada and Worldwide Etienne Proulxeproulx@cardinjulien.comTel: +1 514 272-6798
BD EffivaxTM Glass Prefillable Syringe Features Enhanced Technology that Builds on Company's Decades of Expertise in the Prefillable Syringe Market and Supports Customers' Manufacturing Needs
FRANKLIN LAKES, N.J., Sept. 13, 2022 /PRNewswire/ -- BD (Becton, Dickinson and Company) (NYSE: BDX)
today introduced a next-generation glass prefillable syringe (PFS) that sets a new standard in performance for vaccine PFS with new and tightened specifications for processability
The new BD EffivaxTM Glass Prefillable Syringe has been designed in collaboration with leading pharmaceutical companies to meet the complex and evolving needs of vaccine manufacturing
"As biopharmaceutical companies continue to rapidly grow their vaccine pipelines
demand for PFS is accelerating across the globe – given their proven ability to facilitate faster administration
support dose sparing and reduce vaccine waste." said Eric Borin
Worldwide President of BD Pharmaceutical Systems
"The launch of BD EffivaxTM Glass Prefillable Syringe strategically supports this growth and will create needed efficiencies in end-to-end production."
Approximately 70 percent of the top 100 biopharmaceutical companies rely on BD for supply of PFS.2 BD EffivaxTM Glass Prefillable Syringe will further help customers meet the stringent demands of today's vaccine manufacturing through design enhancements focused on fill/finish and container reliability
BD EffivaxTM is designed to reduce the risk of line stoppage3 and improve the total cost of ownership,4 manufacturing capacity and supply availability
including mRNA and those used for COVID-19
the company remains committed to maintaining robust capacity for PFS to help reduce the time and labor required for vaccine preparation with traditional vial formats
About PFSPrefillable syringes (PFS) are an important option in the packaging and delivery of injectable drug products
PFS help enable the administration of a drug in two ways
a PFS is a drug delivery system designed to administer the appropriate amount of the drug to the patient both safely and reliably
PFS packaging helps assure that there are no adverse effects on the quality
purity or potency of the drug over its full shelf life
Public Relations
201.847.5743
[email protected]
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Customer Quality Specification BD Hypak(tm) for Vaccine SC000110
BD Medical – Pharmaceutical Systems Le Pont de Claix
2 IQVIA-based analysis and BD internal Systems (SAP)
today announced results for its fiscal 2025 second..
today announced that it will present at the Bank of..
Volume 13 - 2022 | https://doi.org/10.3389/fimmu.2022.786859
This article is part of the Research TopicThe Biological and Clinical Aspects of HLA-G, Volume IIView all 16 articles
Preservation of a functional keratinocyte stem cell pool is essential to ensure the long-term maintenance of epidermis integrity
through continuous physiological renewal and regeneration in case of injury
Protecting stem cells from inflammation and immune reactions is thus a critical issue that needs to be explored
we show that the immature CD49fhigh precursor cell fraction from interfollicular epidermis keratinocytes
is able to inhibit CD4+ T-cell proliferation
both the stem cell-enriched CD49fhigh/EGFRlow subpopulation and the less immature CD49fhigh/EGFRhigh progenitors ensure this effect
we show that HLA-G and PD-L1 immune checkpoints are overexpressed in CD49fhigh precursors
as compared to CD49flow differentiated keratinocytes
This potency may limit immune reactions against immature precursors including stem cells
and protect them from exacerbated inflammation
Further exploring this correlation between immuno-modulation and immaturity may open perspectives in allogenic cell therapies
Stem cells are essential for the maintenance and renewal of tissues, thus survival of this cellular pool is critical (1)
we explored the question whether the degree of keratinocyte ‘stemness’ in the interfollicular epidermis is associated with a particular immune status through expression of immune checkpoints
Understanding the immune properties of these adult stem cells will provide information on the mechanisms protecting these cells from immune reactions
and contributing to the maintenance of skin tissue in a stress environment
The present work aimed at investigating whether keratinocyte stem and progenitor cells from the human interfollicular epidermis develop specific immunosuppressive properties by modifying the expression of HLA-G1 and PD-L1 immune checkpoints
enzymatic treatment with a solution containing (v/v) 3/4 grade II dispase 2.4 U mL−1 (Roche Molecular Biochemicals
Germany) and 1/4 trypsin 0.25% (Gibco) was conducted for 24 h at 4°C
We used two categories of cells in this study: cells directly extracted from the tissue and not amplified (tissue keratinocytes)
amplified and used between passage 1 and 3 in culture (amplified keratinocytes)
Amplified adult epidermal keratinocytes were obtained as follows: bulk cultures were generated in a serum-containing medium, in the presence of a feeder layer of human dermal fibroblasts growth-arrested by 60 Gy γ irradiation (23)
All cultures were performed in plastic flasks coated with type-I collagen (BioCoat
The composition of the serum-containing medium consisted of DMEM and Ham’s F12 media (Gibco
10 ng/mL epidermal growth factor (EGF) (Chemicon
and 100 U/mL penicillin/streptomycin (Gibco
keratinocytes were seeded at 1000 cells/cm2 and sub-cultured weekly
Feeder cells were seeded at 5000 cells/cm2
For analysis of cell-surface immune marker expression
keratinocytes were processed as single-cell suspensions and stained for 1 h at room temperature with monoclonal antibodies
The staining monoclonal antibodies used were: phycoerythrin (PE) conjugated rat anti-human CD49f (ITA6) (clone GoH3
Alexa Fluor 405 conjugated rat anti-human EGFR (clone ICR10
PE-cy7-conjugated mouse anti-human PD-L1 (clone MIH1
Alexa 700-conjugated mouse anti-human HLA-G (clone 87G
FITC conjugated mouse anti-human TGFB (clone 1D11
PE conjugated mouse anti-human IL-10 (clone B-S10
Non-reactive antibodies of similar species and isotype
TGFB and IL-10 expression profiles were analyzed using an Astrios cell-sorter (Beckman Coulter
Data were analyzed using FlowJo software (BD Biosciences
Adult epidermal keratinocytes were sorted according to CD49f and EGFR expression
using phycoerythrin (PE)-conjugated rat anti-human CD49f (ITA6) monoclonal antibody (clone GoH3
France) and Alexa Fluor 405 conjugated rat anti-human EGFR monoclonal antibody (clone ICR10
Appropriate isotype controls were systematically used
Cells were sorted using a FACS Aria 3 sorter (BD Biosciences
Keratinocytes were plated in 96 well plates (TPP
Switzerland) at a concentration of 3000 cells/cm2
cells were stained for 1 hour at room temperature using the following monoclonal antibodies: phycoerythrin (PE)-conjugated rat anti-human CD49f (ITA6) (clone GoH3
APC-conjugated mouse anti-human PD-L1 (clone MIH1
Alexa700-conjugated mouse anti-human HLA-G (clone 87G
Nuclei staining was performed using Hoescht (Thermofisher
MHC1 and HLA-G expression profiles were analyzed using AnalysisCellInsight CX7 High-Content Screening (HCS) Platform (Thermofisher
Keratinocytes were seeded at various ratios in 96-well culture plates (collagen-1 96-well
France) and incubated for 4 h at 37°C
in 5% CO2 in 100 μL RPMI medium (Sigma
PBMCs were incubated for 20 min with a proliferation dye (eBioscience Cell Proliferation Dye eFluor 450
then stimulated or not by anti-CD2:anti-CD3:anti-CD28-coated beads (T-Cell Activation/Expansion Kit
and seeded at 100,000 cells per well with or without keratinocytes
PBMC proliferation was quantified by reduction in cell dye intensity after 7 days
The ability of keratinocytes to modulate CD4+ T-cell proliferation was analyzed by comparing CD4+ T-cell dye intensity decrease in the presence versus absence of keratinocytes
cells were stained for 20 minutes at room temperature using Viobright FITC conjugated mouse anti-human CD4 (clone REA623
Significant differences were assessed via 2-tailed Mann–Whitney U-test or t-test
Differences were considered significant for p < 0.05; * = p < 0.05
*** = p < 0.001 and **** = p < 0.0001
We noticed that no effect was observed in the condition with differentiated keratinocytes
contrarily to conditions with immature keratinocytes
although responder cells and beads were the same in every condition
This result rules out steric hindrance as a mechanism for responder cell proliferation inhibition
Tissue keratinocyte precursors were therefore more effective than differentiated keratinocytes in suppressing CD4+ T-cell proliferation
Figure 1 Keratinocyte precursors limit CD4+ T cell proliferation
(A) Representative flow cytometry profiles of keratinocytes directly extracted from the tissue and sorted according to their immaturity level visualized thanks to CD49f and EGFR stainings
10,000 or 100,000 tissue keratinocytes (adult stem cells
progenitors or differentiated cells) from one representative donor were incubated with 100,000 PBMC for 7 days
PBMCs were pre-marked with a proliferation dye
PBMC proliferation was quantified by dye decrease at day 7
(B) Representative flow cytometry profiles at day 7
(C) CD4+ T-cell proliferation inhibition according to the keratinocyte number and immaturity level (mean ± SEM
(D) Representative flow cytometry profiles of amplified keratinocytes sorted according to their CD49f level
sorted according to their CD49f expression after amplification for 7 days
were incubated with 100,000 PBMC during 7 days
(E) Representative flow cytometry profiles at day 7
F CD4+ T-cell proliferation inhibition according to the keratinocyte CD49f expression (mean ± SEM
Exact p-values were determined according to the t-test * = p < 0.05
Keratinocyte precursors therefore retained their ability to reduce CD4+ T-cell proliferation after in vitro amplification
Figure 2 Keratinocyte precursors overexpress the immune checkpoints HLA-G1 and PD-L1
Cells from one representative donor were cultivated for 7
14 or 20 days in a culture medium with serum and a layer of feeder cells
Analysis by high content single-cell image analysis
C) Representative profiles of HLA-G1 and PD-L1 expression according to CD49f expression on keratinocytes amplified for 7 days
D) High content single-cell image analysis of HLA-G1 and PD-L1 levels (Average intensity of fluorescence) (mean ± SEM
G) Representative flow cytometry profiles of HLA-G1 and PD-L1 expression on keratinocytes amplified for 7 days
H) Analysis by flow cytometry of HLA-G1 and PD-L1 expression (mean ± SEM
n=6) according to CD49f level on keratinocytes amplified for 7/14/20 days
Exact p-values were determined according to the Mann-Whitney U-test ** = p < 0.01 and **** = p < 0.0001
Keratinocytes obtained from donor skin samples could be separated into stem cells with an CD49fhigh EGFRlow phenotype, progenitors with an CD49fhigh EGFRhigh phenotype, or differentiated keratinocytes with an CD49flow phenotype (2, 3)
We show here that these populations exhibited distinct immune profiles
whether tissue extracted or amplified in cell culture
exert immunomodulatory properties by inhibiting CD4+ T-cell in vitro proliferation
Investigating the expression of immune checkpoints on keratinocyte precursors in hair follicles could therefore provide a better understanding of their immune privilege and autoimmune-associated pathologies
overexpression of PD-L1 and HLA-G by keratinocyte precursors should be considered in understanding the function of skin tumor initiator cells
the generation of allogeneic skin grafts presents a double stake
the maintenance of epidermal stem cells with high regenerative potential
The raw data supporting the conclusions of this article will be made available by the authors
The studies involving human participants were reviewed and approved by ethical research committee IDF-3
The patients/participants provided their written informed consent to participate in this study
All authors contributed to the article and approved the submitted version
This research received no external funding
All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations
Any product that may be evaluated in this article
or claim that may be made by its manufacturer
is not guaranteed or endorsed by the publisher
and Christelle Doliger from the flow cytometry platform of Saint-Louis Hospital
Authors also thank Alexandre Lellouch (HEGP
The Supplementary Material for this article can be found online at: https://www.frontiersin.org/articles/10.3389/fimmu.2022.786859/full#supplementary-material
Supplementary Figure 1 | Expression of immunomodulatory cytokines by keratinocyte precursors
(B) Expression of TGFB by keratinocytes according to their immaturity level (mean ± SEM
Exact p-values were determined according to the Mann-Whitney U-test
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Received: 30 September 2021; Accepted: 14 January 2022;Published: 11 February 2022
Copyright © 2022 Mestrallet, Carosella, Martin, Rouas-Freiss, Fortunel and LeMaoult. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY)
*Correspondence: Joel LeMaoult, Sm9lbC5MZU1hb3VsdEBjZWEuZnI=; Nicolas O. Fortunel, Tmljb2xhcy5Gb3J0dW5lbEBjZWEuZnI=
†These authors have contributed equally to this work
September 18, 2024 By Sean Whooley
The Neopak XtraFlow glass prefillable syringe. [Image courtesy of BD]BD (NYSE:BDX) announced today that it launched its Neopak XtraFlow glass prefillable syringe and expanded the capacity for the platform
The company said the launch and expansion aim to serve the growing market for biologic therapies
Neopak glass prefillable syringes address key development needs for biologic drugs
The syringes have approval for use with more than 24 indications
BD said it expanded the platform’s usability with the latest commercial release
as the Neopak XtraFlow features an 8mm needle length and thinner wall cannula to optimize the subcutaneous delivery of higher viscosity drug profiles
It achieves this by reducing the injection force and time required for a fixed solution viscosity
The company says this improvement enables pharmaceutical developers to break design barriers
It enhances flow and usability beyond today’s limits compared to a standard half-inch needle
BD also integrated a high-volume manufacturing line at its Le Pont-de-Claix
The integration increases the production capacity of a single line of Neopax syringes by sevenfold for large-scale production
The company says the addition of this line allows for more resilience with supply constraints
“BD is seeing significant growth in the biologics segment
driven by novel drug formulations across indications such as metabolic disorders and oncology,” said Patrick Jeukenne
“With over 30 drugs approved across 12 markets and many more in development with the BD Neopak glass prefillable syringe platform
BD aims to evolve as rapidly as the global biologics pipeline to enable supply and delivery of these drugs for patients worldwide.”
December 2, 2020 By Sean Whooley
Becton Dickinson (NYSE:BDX) announced today that it plans to invest $1.2 billion to expand and upgrade multiple drug-delivery facilities
N.J.-based BD plans to invest the $1.2 billion over a four-year period to expand and upgrade manufacturing capacity and technology for pre-fillable syringes (PFS) and advanced drug-delivery systems (ADDS) across its six global manufacturing locations
while adding another manufacturing facility in Europe
Becton Dickinson’s six manufacturing facilities for its pharmaceutical systems include locations in Columbus
The company anticipates that the Europe facility will be operational by the end of 2023
manufacturing technology enhancements and business continuity improvements
BD has commitments for over 800 million needles and syringes to deliver future COVID-19 vaccines in the U.S.
Canada and elsewhere — a $100 million to $150 million opportunity
“BD invented the ready-to-fill pre-fillable syringe technology
and today’s announcement demonstrates our continued commitment to better serve our customers,” BD Pharmaceutical Systems worldwide president Eric Borin said in the release
BD has added 350 million units of manufacturing capacity for glass barrel pre-fillable syringes
and this new commitment will invest in additional upgrades at all of our Pharmaceutical Systems manufacturing facilities and across multiple product categories
this investment positions BD to have the needed surge capacity for increased pre-fillable syringe demand during times of pandemic response or periods of significant growth of new injectable drugs and vaccines
This significant investment in one of BD’s fastest-growing business units will further advance our leadership position and enable continued strong growth in the years ahead.”
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May 18, 2021 By Sean Whooley
BD (NYSE:BDX) announced today that it will build a more than $200 million drug delivery device manufacturing facility in Spain
The approximately $201.5 million (€165 million) high-tech manufacturing facility in Zaragoza
is expected to create up to 600 jobs by 2030
In December, BD announced its plan to invest $1.2 billion over four years to expand and upgrade multiple drug-delivery facilities
The company said it intended to open the new facility and build upon its six existing sites in Columbus
The company said the new site continues its operations in Spain
a country where BD has three production plants that produce 10 billion medical devices annually
Its facility in Fraga represents a key production site for manufacturing COVID-19 vaccine injection devices
“This new plant will also add needed capacity to support major vaccination campaigns
such as the one currently taking place in response to the COVID-19 pandemic.”
BD plans to start construction on the Zaragoza plant late this year
with the site starting with a workforce of 150 people in an area of 86,000 square feet
it will employ up to 600 people at the facility
which will be expanded to 323,000 square feet by then
The company said the new facility will meet high sustainability and eco-efficiency standards while operating as a fully digital site
The facility is subject to the completion of an administration process
“After the December 2020 announcement of BD’s intention to build a new plant in Europe
a detailed site location search process resulted in Zaragoza
Aragon being selected because of the optimal conditions offered by the region
the synergies that could be produced with BD’s Fraga facility
and the results and excellent performance of the plants that currently exist in Spain,” BD general director in Spain & Portugal Lourdes López said
The Danish cyclist had even looked like an early contender for the final mountain stage, a 152.8km ride from Le Pont-de-Claix to La Bastille in south-eastern France with a steep climb to the finish.
Read moreBut despite an attack with one kilometre to go, the Jumbo-Visma rider was no match for Giulio Ciccone of Trek-Segafredo. Ciccone bounced back from missing the Giro d’Italia owing to Covid-19 and dedicated his victory to his fiancee
“My condition wasn’t 100% so I started here with the Tour de France in my head but saw this week my condition getting better and better
So I’m really happy to close this week with a victory,” Ciccone said
Vingegaard will celebrate overall victory after beating Adam Yates
who finished 2min 23sec behind after nearly 30 hours of racing
“It’s a very big thing for me to win this race
So of course I’m very happy to win,” said Vingegaard
who recently extended his contract with Jumbo-Visma until 2027
View image in fullscreenVingegaard cracks a smile while standing atop the podium
Photograph: Anne-Christine Poujoulat/AFP/Getty Images“I think I can be very satisfied with the whole week
I’m in a good shape and the whole team rode fantastically
Free weekly newsletterThe best of our sports journalism from the past seven days and a heads-up on the weekend’s action
I’m surprised with the gaps in the overall standings
Now I’ll relax a few days and then I’ll do the last bit of preparation for the Tour de France
December 2, 2022 By Sean Whooley
BD (NYSE:BDX) announced recently that it inaugurated a new $38.6 million manufacturing facility in Tijuana
Government officials from Mexico and the state of Baja California joined in the opening of the medication management plant
BD plans for the facility to produce devices and technologies that improve medication safety within healthcare settings
The company expects to add 500 new jobs there over the next two years
BD plans to create 75 jobs responsible for manufacturing automated dispensing cabinets that dispense medication to patients
the company intends to export these devices to North America
“Our new facility in Tijuana is BD’s 12th manufacturing plant in Mexico and is a testament to our commitment to Mexico and the strong relationship we’ve built in communities across the country over the past 65 years,” said Julio Duclos
“The 17,000 BD employees in Mexico are focused on producing high-quality medical devices that are used by health care providers and patients around the world
We look forward to continuing to grow in Mexico.”
BD plans to build upon its six existing sites in Columbus
Ben O'Connor (AG2R Citroën Team) was next best in the overall standings
Wout van Aert won the points classification and Jumbo-Visma claimed the best team classification and two stages
while Tobias Halland (Uno-X) showed his promise by winning the best young riders' classification
The Critérium du Dauphiné has been a traditional form-check for the Tour de France since its inception in 1947
It was created by the newspaper Le Dauphiné Libéré much like the Tour started out as an idea to boost circulation for l'Auto
The race was originally known as the Critérium du Dauphiné Libéré
but after the newspaper ended as title sponsor and the Tour de France organisers ASO took over
Although the Dauphiné is considered a test for the Tour
only 10 riders have won both races in the same year
2016) while Bernard Hinault did the double in 1979 and 1981
The most victories in the Dauphiné by a single rider stands at three: Luis Ocana (1970
- Investment includes new manufacturing facility in Europe
today announced plans to invest approximately $1.2 billion over a 4-year period to expand and upgrade manufacturing capacity and technology for pre-fillable syringes (PFS) and advanced drug delivery systems (ADDS) across its six global manufacturing locations and add a new manufacturing facility in Europe
The new manufacturing facility in Europe is expected to be operational by the end of 2023
The investment will also fund capacity expansion
manufacturing technology enhancements and business continuity improvements across its existing network
all designed to maximize supply and reduce risks for pharmaceutical companies that rely on ready-to-fill syringes for their injectable drugs — including complex biologics
vaccines and small molecules.
"BD invented the ready-to-fill pre-fillable syringe technology
and today's announcement demonstrates our continued commitment to better serve our customers," said Eric Borin
This significant investment in one of BD's fastest growing business units will further advance our leadership position and enable continued strong growth in the years ahead."
The six current manufacturing facilities for BD Pharmaceutical Systems that will see a portion of this investment include facilities in Columbus
Kristen M. Stewart, CFABD Investor Relations201.847.5378[email protected]
Logo: https://mma.prnewswire.com/media/1346788/BD_Logo.jpg
Ciccone hangs on from the breakaway on ultra-steep final climb above Grenoble
Victor Campenaerts (Lotto Dstny) in the Polka Dot Mountain Jersey
David De La Cruz (Astana Qazaqstan) and Clément Champoussin (Arkea Samsic) in the stage 8 breakaway(Image credit: Getty Images)Jonas Vingegaard (Jumbo Visma) in the Yellow leader jersey descends safely on stage 8 (Image credit: Getty Images)Omar Fraile (INEOS Grenadiers) at the front of the breakaway on stage 8 (Image credit: Getty Images)LR Giulio Ciccone (Trek Segafredo)
first place Jonas Vingegaard (Jumbo-Visma) and third place Ben OConnor (AG2R Citroen) on the podium(Image credit: Getty Images)Christophe Laporte (Jumbo-Visma) wins the overall best sprinter of the Criterium du Dauphine cycling(Image credit: Getty Images)Jonas Vingegaard (Jumbo-Visma) sealed the overall title at the Critérium du Dauphiné as Giulio Ciccone (Trek-Segafredo) won the final stage above Grenoble.
Ciccone attacked from the breakaway on the penultimate climb of Col de Porte before soloing down into Grenoble and then fending off Vingegaard on the ultra-steep final climb up to the Bastille Fortress that overlooks the city.
Vingegaard himself responded to efforts from Adam Yates (UAE Team Emirates) on the final two climbs before easing clear in the final kilometre in another disarming display of dominance
As he rode away from an already-small GC group
it looked like he might catch Ciccone to seal his overall title with a third stage win.
But Ciccone held firm on the double-digit gradients
losing his sunglasses that are usually tossed to the crowd whenever he wins
but still celebrating in style as he bounced back from having to miss the Giro d'Italia through COVID-19
my condition wasn't 100% so started here with the Tour de France in the head but saw this week my condition getting better and better
so I'm really happy to close this week with a victory," Ciccone said.
I looked behind and saw I was still in front with some gap
Ciccone made it into a strong breakaway after a chaotic start to a 152.8km final stage that featured six climbs
and then a trio of major ascents ahead of the descent into Grenoble and the kick up the Bastille
was the danger man in the original nine-man move
while Vingegaard placed a teammate there in Tiesj Benoot
along with Ciccone and Clément Champoussin (Arkéa-Samsic) who were left as the front-runners as the break exploded on the hors-catégorie Col du Granier (9.6km at 8.6%)
They rode together over the Col du Coucheron (7.7km at 6.2%) with a slim advantage over the Jumbo-led bunch before Ciccone let rip and went solo on the Col de Porte (7.4km at 6.8%)
He extended his lead to almost minute on the 15km descent but and then refused to fade on the final 1800-metre climb that averaged an eye-watering 14.2%
Vingegaard couldn't quite make up enough ground to deny the Italian but he still handed his GC rivals another sound beating
UAE Team Emirates shredded the bunch on the Col de Porte and Vingegaard marked an opening attack from Yates there before Rafal Majka returned on the descent to bust the 15-man GC group open again on the final climb
Vingegaard took control and eased clear with a seated acceleration
He closed to within 30 seconds but had to settle for second place on the day
with Yates crossing the line in third place 10 seconds later to seal second overall
Ben O'Connor (AG2R Citroën Team) finished fourth
to fend off Jai Hindley (Bora-Hansgrohe) and clinch the final spot on the podium
Vingegaard claimed the third WorldTour stage race crown of his career - after the Tour de France and Itzulia Basque Country - with the biggest winning margin at the Dauphiné in 20 years
"It s very very big for me to win this race
so I'm very happy to win," said Vingegaard
"Yeah in some kind of way I'm surprised [by the winning margin]
Now I relax for a few days then start preparing the last bit for the Tour de France
I still have a little bit of work to do but not a lot."
The stage started out in breathless fashion
uphill almost from the flag and with no shortage of interest in the breakaway
The day's break did form on the the Côte de Pinet (6.3km at 6.1%) but it went through various changes and iterations before the top of the climb.
Ciccone himself jumped across to it from the peloton
as big-name GC riders like Richard Carapaz (EF Education-EasyPost) and David Gaudu (Groupama-FDJ) started moving.
They were reabsorbed but Ciccone went again alongside polka-dot jersey wearer Victor Campenaerts (Lotto Dstny) and they were joined by six other riders near the top: Alaphilippe
Campenaerts took the maximum five points at the top of the Pinet to extend his lead in the mountains classification
With the gap at just 30 seconds on the subsequent rolling plateau
more riders looked to bridge across and three were successful: Benoot
Nelson Oliveira (Movistar) and Matteo Trentin (UAE)
The nine-man group extended their lead to 1:15 over the Col des Mouilles (3.9km at 7%) after 45km - with Campenaerts once again taking maximum points - and then moved out to 2:30 on the subsequent stretch through the valley
After the intermediate sprint in Pontcharra with 65km to go - also won by Campenaerts - it was time for the real climbing
and Porte to scale before the Grenoble finale
The Granier saw an almost-immediate selection in the breakaway
and - after a bit of yo-yo-ing - Champoussin soon the last man standing
Ineos Grenadiers took it up and started to reduce the gap
but then decided to send Jonathan Castroviejo on the attack
sitting back to allow Jumbo-Visma to pace as the Spaniard set about trying to bridge to the break.
The bunch crested the Granier 1:15 down on the leaders but that grew as the break upped the pace on the Cucheron
where Castroviejo made an enormous effort to go from dangling ahead of the peloton to joining the break inside the final kilometre of the climb
Benoot wasn't contributing but still helped himself to the mountain points atop the Granier and Cucheron.
Onto the Col de Porte and the moves had to be made early
taking over from Jumbo-Visma's Dylan van Baarle to force a tempo that immediately raised the stakes
Riders like the Ineos duo of Dani Martinez and Egan Bernal were dropped and soon only 15 riders remained
Ciccone knew he couldn't hang around and launched a vicious acceleration to which only Alaphilippe could respond
Yates tried an attack near the summit but was marked by Vingegaard and eventually
the other members of that GC selection scrambled back
Louis Meintjes (Intermarché-Circus-Wanty)
Pedrero attacked and took a slim lead onto the descent
while Majka came back with Castroviejo and Carlos Rodriguez (Ineos Grenadiers)
But things exploded once again on the steep final ramps in the final 1800 metres.
Majka took it up for Yates and they passed Pedrero as only Vingegaard
Vingegaard made his move and was away with a minimum of fuss.
and the finale turned into a pursuit of Ciccone for the stage win
had enough power in the legs and rode impressively through the final couple of horrifically steep bends to claim his third win of the season
Results powered by FirstCycling
Save A young Denise Maso stands on the balcony of an apartment in Le Pont-de-Claix
(Courtesy of Marion Renault)On her first night home from the hospital
“Qu’est-ce que j’ai fait?”: “What did I do?”
is 82 and in the late stages of Alzheimer’s disease
which means she can no longer form new memories
Late last summer—it’s impossible to say when
Pain became the fall’s only remnant evidence
to understand why she’d stopped eating or getting out of bed
In anticipation of her second discharge from the hospital
When I arrived at the apartment where she lived alone
I was entirely unprepared for how intensely the Alzheimer’s could amplify her suffering
My grandmother’s throat rattled with every breath
she kicked her legs and flailed her arms when I tried to get her out of bed to eat
She developed a cough so intense that it sounded
and sometimes did turn into vomiting as her body tried to convulse the pain away
resulting in a panic that made her even more vulnerable to its punishment
“To have pain is to have certainty,” the essayist Elaine Scarry wrote in her 1985 book
“To hear about pain is to have doubt.” Helping someone cope with pain requires glimpsing
the invisible interior of another person’s body—and then accepting that imagined suffering as real and true
When a patient’s cognitive condition prevents reliable self-assessment
our ability to see a person’s pain and treat what we see is even further limited
the riddle of their suffering becomes nearly unsolvable
can undermine the entire process of conveying pain
A person with Alzheimer’s might express discomfort by wandering
but the same behaviors might express loneliness
or sadness—or they might be symptoms of the disease itself
Asked to choose which emotional expression on a chart matches their current state
point to the face they think they should feel
told me about a patient who complained of frequent headaches
Only later did she realize that “headache” was the woman’s metaphor for not being able to remember
“It just adds to the complexity of taking care of people with Alzheimer’s disease,” Brangman said
“That person may not be able to communicate what’s wrong with them.” Instead of figuring out how to ease the suffering
caregivers are stuck simply trying to understand its source
“It’s a population that’s just silently suffering,” Todd Monroe
a registered nurse and neuroscientist at Ohio State University
In addition to the five senses, nineteenth-century German academics believed in Gemeingefühl: a slate of perceivable bodily states “in the most diffuse and general sense”—fluctuating temperatures
“and perhaps throw light on what parts of the brain were involved in producing such feelings.”
Read: Beating Alzheimer’s with brain waves
Melzack’s invention, the McGill Pain Questionnaire
asked patients to describe their pain using words that fell into three categories: the sensory
The sensory category identifies pain’s physicality through qualities such as temperature
or sting—and each of these sensations can be unlike any of the others.)
affective category capture pain’s emotional impact—whether it exhausts or sickens
and most narrow evaluative category assesses the overall episode: Was it annoying
language can provide “an external image of interior events,” as the essayist Scarry put it
Questionnaires like the MPQ also elevated pain from a handful of physical symptoms to an experience nested in emotion
and there’s the suffering of pain,” says Nancy Berlinger
Alzheimer’s irreversibly robs a person of the cognition required to make this conception of pain medically useful
a person loses the ability to create new memories
or convey the world around and inside them
Over the past quarter century, about 30 different tools or methods have been developed to specifically assess pain in people with dementia. Unfortunately, general practitioners who take care of these patients are often not even aware of their existence. (A 2018 survey of 157 GPs in Ireland found while 98 percent of respondents agreed that dementia makes pain difficult to assess
only 10 percent were aware of any dementia-specific pain-assessment tools.) And evidence for their effectiveness often comes from studies with small sample sizes and other sources of biases
Among the dozens of options, there is no general agreement on which instrument or technique should be recommended for patients with dementia
“There’s not one single tool that’s determined to be the best,” Monroe
is the uncertainty about how Alzheimer’s disease affects a person’s various pain-perception networks
It’s clear that the disease impacts their ability to assign meaning to pain
That has led to some cruel assumptions about people with Alzheimer’s
some caretakers—professional and otherwise—decided it wasn’t worth the hassle of treatment if the patient couldn’t perceive physical sensations or would soon forget any unpleasant episodes
I would hear that Alzheimer’s patients don’t feel pain
or they don’t feel it as much,” Monroe says
The body processes pain through several interconnected neural networks that help a person feel, describe, understand, and respond to pain. Preliminary research in neuroscience suggests that the major brain regions involved in pain perception and processing still function
there’s no absence of brain activity in the areas related to pain
“If somebody thinks dementia has just messed the brain up so much they don’t feel pain
five years of active recruitment led by a dedicated recruitment specialist and a full-time research assistant resulted in the successful testing of fewer than two participants
The result is that most of the existing clinical research has been conducted on participants who are younger
and more mobile than the overall dementia population (women and Black and Latino people are the most likely to develop dementia)
Any treatments based on these studies might not work as well in patients not represented in the trials—which is to say
“I don’t think we have enough answers,” Brangman told me
Evelyne and Jocelyne.Without reliable research to guide them
caregivers are left to rely on their patients’ visible symptoms of untreated discomfort—exclamations like “Ow” or “Ouch,” and movements like massaging
But even for people closest to the patient
Brangman has seen patients become agitated not because of pain or anger
but because of low blood sugar or high blood pressure
They might stop sleeping because they’re uncomfortable or cold or stop eating because they’re lonely
told me her mother often complained of chest pain and trouble breathing in the last five years of her life
Doctors told McDaniel it was only allergies
though allergy medicine did nothing to alleviate any discomfort
Some suggested that her mother wasn’t feeling the pain she was describing
One doctor wrote it off as a cry for attention
McDaniel’s mother had been suffering from breast cancer
She died less than six months after the cancer diagnosis
“We didn’t put two and two together until it was much too late,” McDaniel said
“I still feel guilty to this day for not listening to her instead of the doctors.”
Read: Is the leading theory about Alzheimer’s wrong?
“You have to look for other signals that they’re uncomfortable
And it’s not one set thing,” Brangman said
“It takes a lot of intuitive work and careful examination.” Given the tightening squeeze on geriatric care in the U.S.
it’s not always possible for practitioners to form these kinds of close
sustained relationships with their patients
and even fewer of them are trained to deal with the complexities of dementia
As the number of people with Alzheimer’s more than doubles by 2050
In the absence of a robust professional workforce, family members, friends, or other unpaid caregivers provide a large majority—about 83 percent—of elderly care. Among them, more than 16 million provide an estimated $244 billion worth of care for those with Alzheimer’s or other forms of dementia
but they must nevertheless try to translate subtle facial expressions or unusual habits to doctors and nurses when they suspect that a person with dementia is suffering from untreated pain
Many of the experts I spoke with had relatives or friends who had suffered from these diseases
Monroe’s grandmother battled breast cancer and Alzheimer’s at the end of her life
they felt a powerlessness they’ve tried to dismantle through research or medical care
Alison Anderson, a nurse practitioner and dementia researcher at Vanderbilt University, watched her mother struggle through early dementia as she began studying the disease. In 2017, Anderson examined existing research and found study after study suggesting that the basics of care—touch
and the presence of another human being—can help relieve pain in dementia patients
my grandmother now resides in the Alzheimer’s wing of a nursing home
I found that our moments of communion kept her physical agony at bay
We rooted through boxes of old photographs together
and I distracted her with stories about how I had filled my suitcase with sesame bagels for her
all I could do for her was lie down in bed beside her as she whimpered
"BD's new plant in Zaragoza will produce drug delivery devices
primarily for pharmaceutical companies that supply the European market with drugs in pre-fillable syringes such as vaccines and other biologic drugs," said Eric Borin
"This new plant will also add needed capacity to support major vaccination campaigns
such as the one currently taking place in response to the Covid-19 pandemic.”
The plant will initially have a workforce of 150 people and cover an area of 8,000 m2
BD expects to employ up to 600 staff with the plant extended to cover 30,000 m2
BP said it chose Zaragoza after a “detailed location search process” because of the region’s optimal conditions on offer
the synergies available with the firm’s Fraga facility
as well as the “results and excellent performance” of its other plants in Spain
Two more Spanish plants are located in San Agustin de Guadalix and Almaraz
the three existing plants in Spain produce 10 billion medical devices each year and employ 1,500 people
BD added that the Fraga plant is a key site for manufacturing Covid-19 vaccination injection devices
Last December, BD announced a $1.2 billion investment program spread over four years to expand and upgrade its manufacturing capacity and technology for pre-fillable syringes and advanced drug delivery systems
will see projects implemented across six locations worldwide
as well as the addition of the new Spanish plant
The six facilities are located in Le Pont-de-Claix
ProteiNext is an annual symposium that offers a platform for sharing insights on protein analysis
and strategic direction in an exclusive CHEManager International interview
Jonas Vingegaard wins Criterium du Dauphine ahead of Tour de France title defenceReutersJonas Vingegaard (26) warmed up for the defence of his Tour de France crown by winning the 75th Criterium du Dauphine on Sunday
underlining his credentials as one of the favourites for cycling's biggest race
which starts on July 1st.The Danish cyclist had even looked an early contender for the final mountain stage too
a 152.8-kilometre ride from Le Pont-de-Claix to La Bastille with a steep climb to the finish
But despite an attack with one kilometre to go, the Jumbo-Visma rider was no match for Giulio Ciccone (28) of Trek-Segafredo who bounced back from missing the Giro d'Italia due to COVID-19 and dedicated his victory to his fiancée whom he marries next week
"My condition wasn't 100% so I started here with the Tour de France in my head but saw this week my condition getting better and better
So I'm really happy to close this week with a victory," Ciccone said
Nevertheless, Vingegaard will celebrate overall victory after beating Briton Adam Yates (30), who finished two minutes and 23 seconds behind after nearly 30 hours of racing, while Australia's Ben O'Connor (27) was third
"It's a very big thing for me to win this race
So of course I'm very happy to win," said Vingegaard
"I think I can be very satisfied with the whole week
I'm in a good shape and the whole team rode fantastically
I'm surprised with the gaps in the overall standings
Now I'll relax a few days and then I'll do the last bit of preparation for the Tour de France
The Tour de France runs from July 1st to July 23rd
Check out the full results from the Dauphine with Flashscore.
Profile of 2023 Criterium du Dauphine stage 1
Profile of stage 2 of the 2023 Critérium du Dauphiné
Profile of stage 3 for the 2023 Critérium du Dauphiné
Profile of stage 4 of the 2023 Critérium du Dauphiné
Profile of stage 5 for the 2023 Critérium du Dauphiné
Profile of stage 6 of the 2023 Critérium du Dauphiné
Profile of stage 8 of the 2023 Critérium du Dauphiné
Eight stages for the pre-Tour de France form test in June
The 2023 Critérium du Dauphiné
presents riders with a slow build from the rolling terrain of the Puy-de-Dôme department at Chambon-sur-Lac to the highest finish in the race's history on the Col de la Croix-de-Fer over eight stages
2023: Stage 1 - Chambon-sur-Lac to Chambon-sur-Lac
The opening stage takes place around Chambon-sur-Lac
a commune that sits in the shadow of the sprawling Parc naturel régional des Volcans d'Auvergne - an area of 80 dormant volcanoes - one of which
The peloton will have to wait to tackle any major climbs
as they skirt the Super-Besse ski station and tackle instead five category 4 climbs in the foothills
the stage finishes with three loops of a circuit that includes the Côte du Rocher de l'Aigle
the last ascent crested with around 10km to go
before a descent to the finish and uphill kick to the line
Stage 2 of the 2023 Criterium du Dauphine takes place on June 5 with a 167.3km route out of Brassac-les-Mines in Puy-de-Dôme and into Haute-Loire with a finishing circuit in La Chaise-Dieu.
It's a lumpy route with four categorized climbs
but is front-loaded with two category 3 ascents
the Col de la Toutée (2.2 km at 6%) and Col des Fourches (2.7 km at 6.5%)
The two finish laps include the category 4 Côte des Guêtes (1 km at 8%) with another climb inside 10km to go
The sprinters will have their day if all goes to plan on stage 3 with the Critérium du Dauphiné leaving the Massif Central and heading toward flatter ground outside Lyon
Riders must tackle the category 2 Côte de Bellevue-la-Montagne (4.9 km at 5.8%) just 36km into the stage
it should be smooth sailing on this longest stage of the race.
The category 4 Côte de Neulise (7.5 km at 3%) inside 20km to go will hardly get in the way of the sprinters and will probably only spell the end of the day's early breakaway
The battle for the overall victory in the 2023 Critérium du Dauphiné begins in earnest with the 31.1km individual time trial on stage 4
The route is a bit tougher than the similar test in 2022
which Filippo Ganna (Ineos Grenadiers) won by two seconds over Wout van Aert (Jumbo-Visma).
The distance is enough for some contenders to put a minute or more into the pure climbers and last year the similar stage in La Bâtie d’Urfé was where Primož Roglič (Jumbo-Visma) set the stage for his overall victory
The Critérium du Dauphiné gets more complicated on stage 5 as the peloton heads into the Jura department and the climbs get harder and steeper
first two hours will help riders recover from the time trial but they'll need to find their climbing legs by the final 40 kilometres
the Côte de Château-Chalon (4.4 km at 4.5%) at km 97.7 and Côte d’Ivory (2.3km at 5.9%) at km 154.6
They'll top the beastly Côte de Thésy (3.6km at 8.8%) inside 15km to go
so it will undoubtedly be a climber who wins this stage
The build of intensity ramps up another notch on stage 6 of the Dauphiné
The stage from Nantua to Crest-Voland heads into the Alps with one category 2 climb coming in the first half of the day
One category 2 and two category 3 ascents cap off the stage inside the last 20km
The Côte de Droisy (5.4km at 7%) comes 100km before the Col des Aravis (7.8km at 5.7%) so the fight to get into the breakaway will come either before or on the Droisy
but the descent following it will allow some riders to chase back on
The Côte de Notre-Dame-de-Bellecombe (3.2km at 6.1%) comes directly before the final climb to the finish
the Côte de Crest-Voland (2.3km at 6.6%) without much descending to break it up
Profile of stage 7 of the 2023 Critérium du Dauphiné(Image credit: ASO)Profile of the Col de la Madeleine(Image credit: ASO)Profile of the Col du Mollard(Image credit: ASO)Profile of the final climb
the Col de la Croix de Fer(Image credit: ASO)The queen stage of the 2023 Critérium du Dauphiné comes on the penultimate stage with the highest finish in the event's history (by three metres) coming on the Col de la Croix de Fer
At just 147.7km in length and the first of two hors categorie climbs coming at the midpoint
there could be attacks from the overall contenders early in the stage
The riders hit the Col de la Madeleine (25.1km at 6.2%) at kilometre 75.5
then have a long descent and chase through the valley to the Col du Mollard (18.5km at 5.8%) at km 127.9.
it's less than 20km to the summit of the Col de la Croix de Fer with little in the way of descents for recovery
The final climb is 13.1km and averages 6.2%
but that belies the punishing sections of double-digit grades including the final kilometre
Riders crested the Croix de Fer in 2022 but it was a mid-stage climb
It's been featured 21 times in the Tour de France and five other times in the Dauphiné
but this is the first time the climb has been used as a stage finish
the final stage of the Critérium du Dauphiné is no cakewalk
This 152.8km stage has six categorised climbs including the final kick to the Bastille of Grenoble
with two category 2 climbs - the Côte de Pinet (6.3km at 6.1%) and Col des Mouilles (3.9km at 7%) in the first 50km and four climbs in the last 50km
The hors categorie Col du Granier (9.6km at 8.6%)
category 2 Col du Cucheron (7.7km at 6.2%) and Col de Porte (7.4km at 6.8%) will batter the riders before they face the killer climb to the Fort de la Bastille
It's 1,800 metres long but a ridiculous 14.2% average and a section of 22% grades
A punishing finale that will certainly produce a worthy winner
she coordinates coverage for North American events and global news
As former elite-level road racer who dabbled in cyclo-cross and track
Laura has a passion for all three disciplines
When not working she likes to go camping and explore lesser traveled roads
UCI governance and performing data analysis
The Team Sky rider, who went on to win the Tour after his Dauphiné wins in 2013 and 2015
ended the final stage 12 seconds ahead of the Frenchman Romain Bardet
The final 151km seventh stage from Le-Pont-de-Claix to Superdévoluy was won by another Briton Steve Cummings (Dimension Data)
“Coming into this week I hoped I’d be fighting for the podium,” Froome told Eurosport
It is great timing to have a win under the belt
it does help build the morale a bit and build the team around me
“There’s still some work to do before July
I’ve not raced much this year in order to be at my best during the third week of the Tour.”
the battle for general classification unfolded behind him on the ascent of the Col du Noyer
Tinkoff’s Alberto Contador attacked twice and forced Froome to react
with Bardet (AG2R-La Mondiale) and Richie Porte (BMC) paying close attention
including the first nine in the overall rankings
Dan Martin (Etixx-Quick Step) claimed second – 3min 58sec behind Cummings – ahead of Bardet
who took second overall in the race ahead of Martin as Porte was displaced from the podium places
In the overall standings Froome finished in 29hr 59min 31sec to give him the win over Bardet with Martin a further seven seconds back
two seconds in front of Porte in the final rankings
Metrics details
Immunogenicity of recombinant human acid-alpha glucosidase (rhGAA) in enzyme replacement therapy (ERT) is a safety and efficacy concern in the management of late-onset Pompe disease (LOPD)
long-term effects of ERT on humoral and cellular responses to rhGAA are still poorly understood
To better understand the impact of immunogenicity of rhGAA on the efficacy of ERT
clinical data and blood samples from LOPD patients undergoing ERT for >4 years (n = 28) or untreated (n = 10) were collected and analyzed
anti-rhGAA antibodies peaked within the first 1000 days of ERT
while long-term exposure to rhGAA resulted in clearance of antibodies with residual production of non-neutralizing IgG
Analysis of T cell responses to rhGAA showed detectable T cell reactivity only after in vitro restimulation
Upregulation of several cytokines and chemokines was detectable in both treated and untreated LOPD subjects
while IL2 secretion was detectable only in subjects who received ERT
These results indicate that long-term ERT in LOPD patients results in a decrease in antibody titers and residual production of non-inhibitory IgGs
Immune responses to GAA following long-term ERT do not seem to affect efficacy of ERT and are consistent with an immunomodulatory effect possibly mediated by regulatory T cells
Here we characterized the immune responses to rhGAA in a large cohort of LOPD subjects either receiving long-term ERT or untreated
In this study we demonstrate that rhGAA infusion results in the early production of high-titer antibodies in a subset of subjects
however antibodies appear to drop over time with continuation of ERT
IgG subclass characterization shows production of non-inhibitory antibodies with no evident effect on enzyme activity or uptake
while rhGAA-specific T cell activation profile is consistent with immune modulation
Long-term ERT in LOPD patients results in a decrease of anti-rhGAA antibodies
Anti-rhGAA IgG1 and IgG4 are the most prevalent subclasses of antibodies developed in response to long-term ERT
(A–F) Anti-rhGAA antibodies measured with a capture assay specific for IgG1
Estimated antibody concentrations are reported for each subject
Average and standard deviation are indicated for each of the study cohorts: LOPD subjects receiving ERT (Treated
Unpaired two-tailed t-test was used to compare results across the study cohorts (**P < 0.01)
T cell reactivity to rhGAA is detectable after restimulation of PBMCs with the antigen
(A) Comparison of IFNγ ELISpot count in PBMCs isolated from LOPD subjects receiving ERT before and after DC-mediated restimulation
Cells were either directly plated in the ELISpot assay (−) or restimulated in vitro with 10 μg/ml of rhGAA prior to the assay (+)
Results are expressed in spot forming units (SFU) per 106 cells
Results are reported as average of triplicate testing +/− standard deviation
Images of the test wells in the IFNγ ELISpot assay are shown below the histogram plot
(B) Combined results for all subjects screened with the IFNγ ELISpot assay after PBMC restimulation
PBMCs from LOPD subjects receiving ERT (Treated
Results are expressed as ratio between SFU/106 cells in rhGAA-restimulated cells vs
(C–F) PBMCs from LOPD subjects receiving ERT (n = 3) were restimulated with 10 μg/ml of rhGAA for 48h and then stained intracellularly for IFNγ
Results are reported as percentage of CD4+ T cells secreting a given cytokine
Cytokine profiling of supernatant from PBMCs restimulated with rhGAA
Supernatants from cells restimulated with rhGAA were collected after 48 hours of restimulation in vitro and assayed for cytokine and chemokine production
(A) Levels of IL2 measured in conditioned media in LOPD subjects receiving ERT (Treated
Error bars represent the standard deviation of the mean
Mann-Whitney test was used to compare data across the study groups
(B–L) Cytokine and chemokine concentration in media measured with the Luminex array technology; shown are individual values measured in LOPD subjects receiving ERT (Treated
Error bars represent the average of a cohort +/− standard deviation
(M) Pearson correlation matrix comparing measurements of cytokine and chemokine production in responses to rhGAA in treated (n = 28) and untreated (n = 10) LOPD subjects
Numbers in the table represent the correlation coefficient between two variables with the relative p value (t-test)
(N) Depletion of CD25+ in PBMCs from treated LOPD subjects
The untouched CD25neg PBMC fraction was co-cultured with autologous DCs pulsed with rhGAA antigen or unpulsed DCs as negative control
Results of the IFNγ ELISpot assay are shown as average of spot forming units (SFU) per 106 cells plated in the assay +/− standard deviation of triplicate testing
(O) Sorted untouched CD19+CD24negCD38neg PBMC fraction from treated LOPD subjects co-cultured with autologous DCs pulsed with rhGAA antigen (or negative control) followed by IFNγ ELISpot
Results of are shown as average SFU/106 cells +/− standard deviation of triplicate testing (*P < 0.05; **P < 0.01; ***P < 0.001; ****P < 0.0001
not supporting the involvement of CD19+CD24hiCD38hi B cells in the observed hyporesponsiveness to rhGAA
Serum cytokine and chemokine profiling of LOPD subjects before and after ERT
(A–E) Luminex cytokine and chemokine measurements before (PRE) and immediately after (POST) rhGAA administration (over the course of four hours) in LOPD subjects (n = 10)
Shown are cytokines for which a significant change in serum levels was measured at the end of ERT
Paired t-test was used to compare data analysis PRE vs
POST infusion (*P < 0.05; **P < 0.01)
Clinical outcome measures and statistical analysis of results
(A) % forced vital capacity (FVC) measurements
expressed as % predicted in healthy individuals
over a period of 4 years in 21 treated LOPD subjects; the red line represents the average evolution of the measurement
The estimated slope is −1.16% per year; the estimated intercept is 58.9%; p value is given by linear mixed models (see Methods)
The following equations were used to calculate the % FVC: [FVC predicted for males = 0.060 * height − 0,0214 * age – 4.65]; [FVC predicted for females = 0.0491 * height − 0.0216 * age – 3.59]; [FVC (%) = FVC observed/FVC predicted * 100] (B) Six-minute walk test (6MWT)
measured over a period of 4 years in 19 subjects
the red line represents the average evolution of the measurement
The estimated slope is −2.06% per year; the estimated intercept is 59.6%; p value is given by linear mixed models (see Methods) (***P < 0.001)
The following equations were used to calculate the % 6MWT: [6MWT predicted for males = −309–5.02 * age − 1.76 * weight + 7.57 * height]; [6MWT predicted for females = 667–5.78 * age − 2.29 * weight + 2.11 * height]; [6MWT (%) = 6MWT observed/6MWT predicted * 100]
(C) Spearman correlation of measurements of immune responses to rhGAA with clinical outcome measures recorded at the time of blood collection
The numbers in the table represent the correlation coefficient between two variables with the relative p value (t-test) (NS
In our analysis, no correlation was found between the evolution of FVC and 6MWT and the measurements of immune responses to rhGAA after long-term ERT (Fig. 6C)
consistent with the fact that no neutralizing antibody response was detected after long-term ERT
no relationship between clinical endpoints of disease progression and immune responses to rhGAA is found
the mechanisms driving the immunogenicity of rhGAA in ERT for Pompe disease are largely unknown
residual expression of the endogenous GAA in these subjects may also result in an increased immunogenicity of rhGAA
as we showed that infusion of rhGAA in LOPD patients triggered immediate systemic secretion of several cytokines and chemokines
it is not surprising that the measurements of immune responses after long-term exposure to ERT do not correlate with the longitudinal analysis of 6MWT and FVC
This is likely to be the results of multiple factors
including (1) all subjects after long-term ERT had low residual levels of anti-rhGAA antibodies which were not neutralizing
(2) the fact that the immune responses measured were more consistent with a state of unresponsiveness
to rhGAA and (3) the fact that the immune assays were performed far in time from the peak of antibody responses to rhGAA
thus not warranting the use of immunomodulatory strategies to eradicate anti-GAA antibodies
LOPD subjects included in this study were part of the French registry of adult Pompe disease patients
Approvals from the competent health authorities and the local Ethical Committee of the Pitie-Salpetriere Hospital
were obtained prior to the initiation of the study (CNIL N/Ref MMS/CWR/AR155497; CCTIRS N: 14.520; CCP approval 25/06/2014)
Informed consent was given by each participant prior to inclusion in the study
All the experiments were carried out in accordance with the relevant guidelines for clinical investigation in France and Europe
Study inclusion criteria were diagnosis of PD defined as deficiency of GAA enzyme activity measured in blood or skin fibroblasts
PD diagnosis was confirmed by GAA gene sequencing
Exclusion criteria were age older than 80 years
ongoing or recent (less than 3 months) immunosuppressive treatment
Blood samples were collected via venipuncture in heparin tubes and used to isolate serum and PBMCs
De-identified HD blood samples (n = 43) were collected through the French blood bank (Etablissement Française du Sang
De-identified PD patient fibroblasts lacking GAA activity were obtained from the Coriell Institute repository (Camden
Antibody titers over time in treated subjects were determined as previously described10
To study the IgG subclasses specific to GAA
96-well Nunc Polysorp Immunoplate microplates (Dutscher
France) were coated with rhGAA to a final concentration of 1 μg/ml
A standard curve made of purified human IgG (Gamunex
serum samples were added at dilutions of 1:10 and 1:20 in duplicate and incubated overnight at 4 °C
Monoclonal anti-human Ig biotin-conjugated antibodies specific for each subclass (all from Sigma-Aldrich
Binding of the secondary antibodies was detected with alkaline phosphatase-conjugated streptavidin (Sigma-Aldrich
The enzymatic reaction was developed with p-nitrophenyl phosphate (Sigma-Aldrich
France) substrate and color development was read at 405 nm using a microplate reader (MRX Relevation
Anti-rhGAA antibody concentration was determined against the Ig subclass-specific standard curve using 4-parameters regression
PBMCs were restimulated in vitro according to a protocol designed to enhance detection of antigen-specific T cell responses26
PBMCs from the three cohorts studied were stimulated with rhGAA to a final concentration of 10 μg/ml
Cells recovered after the short-term restimulation protocols were used to perform antigen-specific T cell assays
CD25+ T cell depletion was performed prior to restimulation of PBMC with antigen using magnetic beads conjugated with anti-CD25 antibodies (Miltenyi Biotec
Flow cytometry was used to assess the efficacy of depletion
PBMC depleted of CD19+CD24hiCD38hi B cells were obtained by staining cells with anti-CD19
France) following by sorting on a FACSAria (BD Biosciences)
The IFNγ ELISpot assay was performed as previously described64
rhGAA was used at a concentration of 10 μg/ml
and a mix of 0.05 μg/ml of phorbol 12-myristate 13-acetate (PMA
France) and 1 μg/ml of ionomycin (Sigma-Aldrich
All antigens and controls were tested in triplicate
Intracellular cytokine staining (ICS) was performed by incubating PBMCs from treated LOPD with rhGAA protein (10 μg/ml)
France) were added to the cultures at a concentration of 1 μg/ml and 2 μM
A mix of PMA (0.05 μg/ml) and ionomycin (1 μg/ml) was used as positive control in the ICS assay
cells were harvested and a mix of fluorescently-labeled antibodies specific for the surface markers CD4 (PerCP-Cy5.5
An amine-reactive aqua dye (Life Technologies
Cells were then fixed and permeabilized with Cytofix/Cytoperm (BD Biosciences Le Pont de Claix
France) and intracellular staining was performed using antibodies against IL2 (PE-Cy7
Cells were acquired on a BD LSRFortessa flow cytometer (BD Biosciences
Data analysis was performed using Flowjo software version 10 (Tree star
Supernatants from PBMC restimulation in vitro and serum samples from LOPD subjects were used for the detection of cytokines and chemokines using a multiplexed bead immunoassay based on the Luminex technology
and TNFα) were measured with the Bio-Plex Pro human cytokine 17-plex immunoassay (BioRad
France) following the manufacturer’s instructions
A Bioplex 200 system (BioRad) was used to analyze the samples
All data are shown as mean value +/− standard deviation
Data analysis was performed as indicated in figure legends using GraphPad Prism version 6 (GraphPad Software Inc.
P values lower than 0.05 were considered significant
Hierarchical clustering of the levels of cytokines and chemokines in HD and PD patients was performed with the StatistiXL software (Digital River
UK) using the Pearson correlation coefficient
In both correlation matrices the correlation coefficient r was transformed to t using the formula t = r × [√(n − 2)/√(1 − r2)] for statistical testing and the p value adjusted for multiple comparisons using the false discovery rate method
Long-term exposure to Myozyme results in a decrease of anti-drug antibodies in late-onset Pompe disease patients
Publisher’s note: Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations
In The Metabolic and Molecular Basis of Inherited Disease (ed A
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Mutation analysis of the acid beta-glucosidase gene in a patient with type 3 Gaucher disease and neutralizing antibody to alglucerase
Enzyme replacement therapy induces T-cell responses in late-onset Pompe disease
Immune responses and hypercoagulation in ERT for Pompe disease are mutation and rhGAA dose dependent
Mapping the T helper cell response to acid alpha-glucosidase in Pompe mice
Immunomodulatory gene therapy prevents antibody formation and lethal hypersensitivity reactions in murine pompe disease
Distinct characteristics of antibody responses against factor VIII in healthy individuals and in different cohorts of hemophilia A patients
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IgG4 and IgA by T regulatory cells and toll-like receptors
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acDCs enhance human antigen-specific T-cell responses
Cytokine production by CD4+ T cells specific for coagulation factor VIII in healthy subjects and haemophilia A patients
Functional and molecular comparison of anergic and regulatory T lymphocytes
Cytokines in immune-mediated inflammatory myopathies: cellular sources
multiple actions and therapeutic implications
Transcriptional response to GAA deficiency (Pompe disease) in infantile-onset patients
CD4 T cell hypo-responsiveness induced by schistosome larvae is not dependent upon eosinophils but may involve connective tissue mast cells
CD19(+)CD24(hi)CD38(hi) B cells exhibit regulatory capacity in healthy individuals but are functionally impaired in systemic Lupus Erythematosus patients
Immune response to enzyme replacement therapies in lysosomal storage diseases and the role of immune tolerance induction
The effect of antidrug antibodies on the sustainable efficacy of biologic therapies in rheumatoid arthritis: practical consequences
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A risk-based bioanalytical strategy for the assessment of antibody immune responses against biological drugs
Anti-adalimumab antibodies in rheumatoid arthritis patients are associated with interleukin-10 gene polymorphisms
Anti-dystrophin T cell responses in Duchenne muscular dystrophy: prevalence and a glucocorticoid treatment effect
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Dangerous liaisons: how the immune system deals with factor VIII
Impaired autophagy affects acid alpha-glucosidase processing and enzyme replacement therapy efficacy in late-onset glycogen storage disease type II
McArdle disease: another systemic low-inflammation disorder
Pro-inflammatory cytokines and the pathogenesis of Gaucher’s disease: increased release of interleukin-6 and interleukin-10
Successful immune tolerance induction to enzyme replacement therapy in CRIM-negative infantile Pompe disease
Bortezomib in the rapid reduction of high sustained antibody titers in disorders treated with therapeutic protein: lessons learned from Pompe disease
A longitudinal evaluation of anti-FVIII antibodies demonstrated IgG4 subclass is mainly correlated with high-titre inhibitor in haemophilia A patients
Rapid acquisition of immunologic tolerance to factor VIII and disappearance of anti-factor VIII IgG4 after prophylactic therapy in a hemophilia A patient with high-titer factor VIII inhibitor
Mechanisms of immune tolerance to allergens: role of IL-10 and Tregs
Chronic cat allergen exposure induces a TH2 cell-dependent IgG4 response related to low sensitization
IgG4 inhibits peanut-induced basophil and mast cell activation in peanut-tolerant children sensitized to peanut major allergens
Prolonged immunization results in an IgG4-restricted response
High incidence of anti-FVIII antibodies against non-coagulant epitopes in haemophilia A patients: a possible role for the half-life of transfused FVIII
Immune tolerance improves the efficacy of enzyme replacement therapy in canine mucopolysaccharidosis I
Immune tolerance after long-term enzyme-replacement therapy among patients who have mucopolysaccharidosis I
Enhanced efficacy from gene therapy in Pompe disease using coreceptor blockade
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The strength of persistent antigenic stimulation modulates adaptive tolerance in peripheral CD4+ T cells
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Desensitization of an adult patient with Pompe disease and a history of anaphylaxis to alglucosidase alfa
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David Scott for critical review of the manuscript
Supported by a grant from the Vaincre les Maladies Lysosomales (VML) association
the French Muscular Dystrophy Association (AFM)
This project has received funding from the European Union’s Horizon 2020 research and innovation programme under grant agreement No
Olivier Benveniste & Federico Mingozzi
Pasqualina Colella & Federico Mingozzi
Department of Internal Medicine and Clinical Immunology
Kuberaka Mariampillai & Olivier Benveniste
Neuromuscular Physiology and Evaluation Lab
Centre de référence de pathologie musculaire Paris-Ouest
Centre de compétence de pathologie neuromusculaire
Centre de référence de pathologie neuromusculaire Paris-Est
Service ENMG et Pathologies Neuromusculaires
Service de médecine physique et de réadaptation
Centre de compétence des maladies neuromusculaires
Centre de référence des maladies neuromusculaires rares Rhône-Alpes
Centre Hospitalo-Universitaire de Montpellier
Centre de référence des maladies neuromusculaires
CHU de Bordeaux-GH Sud - hôpital Haut-Levesque
CHU de Lyon-GH Est hôpital Femme-Mère-Enfant
Service de Neurologie D et centre de réference des maladies rares neuromusculaires
Centre de référence des maladies neuromusculaires Nantes-Angers
Centre de référence des maladies neuromusculaires Nantes/Angers
Service de réanimation et unité de ventilation à domicile
Service de soins de suite et de réadaptation neurologie
Centre de référence maladies neuromusculaires de la région Rhône-Alpes
Centre de compétences maladies neuromusculaires
Centre de réference des maladies Neuromusculaires et SLA
Centre de référence des maladies neuromusculaires et de la SLA
groupe hospitalier La Rochelle – Ré – Aunis
Hôpital d’Instruction des Armées Clermont Tonnerre
and the French Pompe registry contributed to the collection of human samples and relative clinical history: G.B.
Pascal Laforet has received grants and honoraria from Genzyme Company
and honoraria from BioMarin and Amicus Therapeutics and all the other authors declare no competing financial interests
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French traffic bans apply to trucks and vehicle combinations with a DMC above 7.5 tonnes
with the exception of special vehicles and agricultural vehicles
This guide explains when the bans are in force in 2021
The truck bans start at 10pm on Saturdays and the evening before public holidays
and last until 10pm on a Sunday or a public holiday
The calendar of holidays in France for 2021 is as follows:
the following additional restrictions will apply in France:
– Prohibitions in winter : from 7 am to 6 pm on the ‘Auvergne-Rhône-Alpes’ roads listed below
20th as well as February 7th and March 6th 2021
– A40 from Pont d’Ain (intersection A40 / A42) to Passy-le-Fayet (intersection A40 / RD1205)
– RD1084 from Pont d’Ain (intersection RD1084 / RD1075) to Bellegarde
– A43 from the A46 south / A43 junction to the A43 / A432 junction towards Lyon-Chambery
– A43 from the intersection A43 / A432 to Frejus Tunnel
– A430 from Pont Royal (intersection A43 / A430) to Gilly-sur-Isere (intersection A430 / RN90)
– RD1090 from Pont-Royal to Gilly-sur-Isere (intersection A430 / RN90)
– RN90 from Gilly-sur-Isere (intersection A430 / RN90) to Bourg-Saint-Maurice
– RD306 (Rhône) and RD1006 (Isère and Savoie) from Saint-Bonnet-de-Mure to Freney
– A48 from Coiranne (intersection A48 / A43) to Saint Egrève (intersection A48 / A480)
– A480 from Saint Egrève (intersection A48 / A480) to Pont-de-Claix (intersection A480 / RN85)
– RN85 from Pont-de-Claix (intersection A480 / RN85) to Vizille (intersection RN85 / RD1091)
– RD1091 from Vizille (intersection RN85 / RD1091) to Briançon
– A41 north from Saint Julien-en-Genevois (junction A40 / A41 north) to Cruseilles (junction A410 / A41 north)
– RD1201 from Saint Julien-en-Genevois to Annecy
– A410 from Scientrier (intersection A410 / A40) to Cruseilles (intersection A410 / A41 north)
-A41 north of Cruseilles (junction A410 / A41 north) to the junction with A43 Chambery
– A41 south between Grenoble and A43 (Francin) on Montmelian northbound
– RD1090 between Montmelian (73) and Pontcharra (38)
– Summer bans: from 7 to 19 for the whole of the French road network on Saturdays: 24 and 31 July and 7
14 and 21 August 2021 r. In the Saturday traffic will be allowed from hours
additional traffic bans will apply as every year
They apply to specific roads in a specific direction and are valid on the following dates:
– on the eve of a public holiday from 4pm to midnight
– Saturdays from 10am to 6pm and from 10pm to midnight
– Sundays and public holidays around the clock
– Saturdays and the eve of public holidays from 10pm to midnight
– Mondays and the day after a public holiday from 6pm to 10pm
The bans in Île-de-France include the following motorway sections:
A6b from the Paris beltway to the intersection with the A6 and A10 motorways (commune of Wissous)
– A106 from the intersection with A6b to Orly airport
– A6 from the intersection with A6a and A6b to the intersection with RN 104-Est / East (commune of Lisses)
– A10 from the intersection with A6a and A6b to RN20 (commune of Champlan)
– A12 from the junction with the A13 (Rocquencourt triangle) to the RN10 (Montigny-le-Bretonneux commune)
– A13 from the Paris ring road to the Poissy-Orgeval junction (Orgeval commune)
truck traffic is permanently banned on some roads in France
– national road N59 between Lunéville and Sélestat – a ban applies on all vehicles in transit with a GVW exceeding 3.5 tonnes
– national road N66 – prohibitions in place for vehicles over 3.5 tons between Remiremont and Cernay; ban for vehicles over 19 tonnes between 6am-10pm
with a loading or unloading point in Lorraine (Lorraine) or Alsace (Alsace)
national road N227 (3 – 4 km) – prohibition for vehicles in transit over 3.5 tonnes leaving the A1 motorway and heading north
– A557 motorway – prohibitions for vehicles over 3.5 tons
– A55 motorway (4 km) – prohibitions for vehicles over 3.5 tons in Marseille
between the Vieux Port intersection and the Cap Pinède intersection
– connection of the A50 (Toulon est / Toulon east) and A57 (Toulon est / Toulon west) motorways – Toulon tunnel – no heavy goods vehicles over 19 tonnes going to Marseille
– A8 motorway – a 24-hour ban on the carriage of ethylene oxide by road on the section between the toll station in Antibes and Italy. For this type of transport
the sea route Lavera – Tavazzano is recommended
– national road N7 – traffic ban for vehicles over 6 tons on the transit route through the Orange agglomeration
between the intersection with the RD976 and the intersection with the RD950; a ban on vehicles with a GVW of over 16 tons on the transit route through the Mondragon agglomeration
– national road N85 – no vehicles over 26 tons (not equipped with speed limiters) on the border of the departments of Isère and Hautes Alpes and the city of Gap
– national road N580 – traffic ban for vehicles over 25 tons in Avignon
– national road N94 – vehicles over 26 tons (not equipped with speed limiters) between the southern Embruns roundabout and the border with Italy are prohibited
– A7 and A6 motorways (25 km) between Ternay and Anse – vehicles with a DMC above 7.5 t are prohibited
– national road N205 (Mont-Blanc Tunnel) – no vehicles carrying hazardous materials
vehicles with a height exceeding 4.7 m and cars meeting Euro 0 emission standards
– A43 motorway Fréjus tunnel – no vehicles carrying class 1 hazardous materials
vehicles with a height exceeding 4.3 m and cars meeting Euro 0 emission standards
– A47 motorway – traffic ban on the section connecting A47 (westbound) and A7 towards Lyon city center (Ternay intersection)
– national road N7 – traffic ban for vehicles with a GVW over 6 tonnes
– national road N7 in Tain l’Hermitage – no vehicles over 3.5 tons southbound
between Vienne and the Roussillon toll station
– national road N85 Laffrey – traffic ban for vehicles with a GVW above 7.5 t
– Lyon North Bypass – vehicles with a height exceeding 3.5 m
and trucks over 19 tons and vehicles carrying hazardous materials are prohibited
– Fourvière Tunnel – vehicles with a height exceeding 4.3 m
and for trucks transporting hazardous materials are prohibited
Photo credit: François GOGLINS / Wikimedia Commons
Pölös Zsófia Journalist Trans.info | 6.05.2025
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You can read this article in 5 minutesAgnieszka Kulikowska - Wielgus
The French authorities have published dates for additional winter and summer truck traffic restrictions
Photo credits @ Wikimedia Commons (illustrative purposes only)
the French Ministry of the Interior issued a decree supplementing the general system of traffic restrictions for heavy goods vehicles with a gross vehicle weight (GVW) of over 7.5 tonnes
The decree introduces additional winter traffic bans on the road network in the “Auvergne-Rhône-Alpes” region
These restrictions will be in effect on Saturdays
Bellegarde and Saint-Julien-en-Genevois – Annecy – Albertville
truck traffic is restricted across the entire road network of mainland France on Saturdays
and fans can expect another blockbuster Championship filled with sensational rugby
team tries and moments of individual brilliance
In anticipation of the start of Rugby’s Greatest Championship
Planet Rugby has a closer look at key players from each team
The Italian superstar was
where he would later go on to represent the French Pro D2 club Grenoble over 50 times in a three-year stint
Courtesy of his Italian father, Capuozzo came through the Italy U20 ranks and Italy ‘A’ before making his international debut in last season’s Six Nations
scoring a brace against Scotland in his first Test
Toulouse snapped up the speedster who would kick on from a positive debut and finish 2022 as World Rugby’s Breakthrough Player of the Year
Capuozzo is regarded as one of rugby’s greatest prospects
as he is expected to take his game even further despite his relative inexperience at the highest level
The outside back’s X-factor and running ability are what separate him from others
There is this sense of anticipation every time Capuozzo touches the ball
as a moment of magic could happen at any moment
which he instinctively uses to unlock defensive lines to either go on his own or play a teammate in
Undoubtedly anything venomous coming from Italy in this year’s Six Nations likely has Capuozzo’s fingerprints on it
Whilst no great weaknesses have dramatically shown their head
the most obvious one is lack of physicality
Capuozzo does not offer much on the physical front
rugby has seen the likes of Cheslin Kolbe thrive at any level
although it is inevitable that in certain situations
he will come off second best in the collision
Capuozzo’s Test career began around this time last year when he burst onto the scene with a brace against Scotland
it would not be his greatest moment in the championship
which came in the last round against Wales
There were only a couple of minutes left on the clock with Italy in striking distance but never looked like winning until the ball got cleared to the Italian phenom
Capuozzo received possession in his own half
skirted around the defensive line and found space in the right-hand flank
He proceeded to slalom past a defender before tipping it off to teammate Edoardo Padovani who scored with seconds left
History for Italy as they claimed their first win in Cardiff
the rugby world knew the name Ange Capuozzo
🇮🇹 Ange Capuozzo, take a bow ❤️pic.twitter.com/vweWr0TCju
— Planet Rugby (@PlanetRugby) March 19, 2022
The young star is arguably the brightest prospect on the globe
He is potent with ball in hand and knows his way to the try-line
no doubt head coach Kieran Crowley will want his players to get the ball to Capuozzo in the right spaces as much as possible
It is a massive championship for the outside back as the rugby world will watch to see if he can kick on and become one of the greatest Italian players in years to come
READ MORE: Six Nations: Wales hand Leigh Halfpenny first start in 19 months for Ireland opener
Toulouse’s Champions Cup title defence entertainingly ended at the semi-final stage as Bordeaux produced a steeled hometown performance to fully merit their progress to the decider
Following a 38-15 victory for Toulouse against Sale Sharks in their Champions Cup round of 16 clash
here's James While's five takeaways from the game
Following a 38-15 victory over Sale Sharks in the Champions Cup round of 16 clash at the Stadium Toulouse
Toulouse have reportedly come to a decision on how they will cover for Antoine Dupont