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When Pierre Lemieux and his team at Acasti Pharma went looking for a pharmaceutical manufacturing partner
they had a surprising amount of trouble finding one
The reason was the type of drug they are developing
The active ingredient in Acasti’s lead product
which lowers triglyceride levels in people at risk of cardiovascular disease
and not everyone wants to work with krill oil
natural product extraction is an art not widely practiced among drug outsourcing firms
and some potential partners were concerned about contaminating their facilities with shellfish allergens
extracting the active ingredient involves acetone
a flammable solvent some companies weren’t prepared to handle
A krill oil plant operated by Acasti’s then parent company exploded in 2012
It was having success in early trials of its
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It was having success in early trials of its drug and would soon need a partner with facilities approved by the U.S
Food & Drug Administration so it could pursue larger-scale trials in North America
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Clinical-stage manufacturing of its active ingredient would be one more step in a journey for Acasti that began a decade ago when the Canadian company now called Neptune Wellness Solutions spawned the drug firm
Neptune was selling krill oil rich in omega-3 fatty acids to the dietary supplement market
and it saw an opportunity to move into the regulated pharmaceutical arena
a fish-oil-based drug now sold by GlaxoSmithKline
approval in 2005 and was rapidly racking up sales
Lemieux came aboard in 2010 to help lead Acasti’s effort to launch a competitor to Lovaza
Neptune is now a minority shareholder in Acasti
is that its oil comes from krill rather than fish
the omega-3s—eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA)—are converted into ethyl esters to provide stability during purification
Acasti points to tests showing that the esterified oils are most effective when ingested with high-fat meals—not ideal for people with heart conditions
are either free fatty acids or bound to phospholipid esters
Acasti’s Phase I and II clinical trials show that CaPre’s bioavailability is far less affected when it’s taken on an empty stomach or with a low-fat meal than is Lovaza’s
biochemist who is Acasti’s chief operating officer
trial data show that CaPre lowers triglycerides while also benefiting both good and bad cholesterol
The firm’s scientists don’t fully understand why
but they suspect it has to do with the role that phospholipids play in how the body manages cholesterol
Two Phase III clinical trials of CaPre are ongoing
and Acasti expects to be able to report data by the end of 2019
One of CordenPharma’s first acquisitions was a facility in Chenôve
CordenPharma’s global director for small molecules and antibiotics
says the plant was a good candidate for the Acasti job
It had experience with natural products and was already producing an extract from tree bark
the CordenPharma team saw a problem: Daily doses of the omega-3s are measured in grams
not milligrams like many small-molecule drugs
Extracting the required amount of EPA and DHA a batch at a time would involve large vessels and large amounts of solvent
“Phase III supply would be a challenge,” Houldsworth says
“and commercial was never going to be able to be done at Chenôve.”
realized the solution might be to move from a traditional batch-manufacturing process to a smaller and safer continuous one
“They did a quick proof-of-concept experiment with very crude equipment and presented it to Acasti,” Houldsworth says
CordenPharma had previously tried to convince customers to adopt continuous manufacturing, Houldsworth recounts. But as is often the case in the drug industry, conservatism prevailed. It was an easier sell for Acasti, according to Lemieux, because some people on his team, aware of the Neptune accident, were thinking along the same lines.
After the contract was signed, the partners worked with a process equipment firm to design a continuous decantation system. The equipment firm then built it, shipped it to Chenôve, and installed it on skids. “The footprint is a fraction of what the batch process would require,” Houldsworth says. The amount of solvent in the system at any given time is similarly reduced.
The partners’ adoption of a continuous-flow process comes at a time when FDA is advocating for more continuous production in the drug industry. It released several bulletins last year championing the approach. Not surprisingly, Lemieux says the agency responded supportively when informed of the plan to go continuous.
In addition to cost and safety improvements, a continuous process can offer better analytical control. In a batch process, Houldsworth notes, the analytical testing required for product release happens after making a batch. “In continuous processing, you push a lot of analytical testing into the process,” he says. “You get continuous data feedback and know almost instantly what the process is doing and how it’s performing.”
Continuous processes do involve batches, but they are defined by time or volume. To date, CordenPharma has made a number of such batches for Acasti’s Phase III trials. Houldsworth says the plant is now gearing up to start the process validation that is required before the company files a New Drug Application with FDA.
Lemieux and his team are already starting to think about what comes next. The current facility can produce about 20 metric tons of the CaPre active ingredient per year—enough, he figures, for the drug’s first few years on the market. But if CaPre is as successful as Acasti hopes it will be, the firm will need a second, 200-metric-ton facility. Houldsworth would love to see it get built in Chenôve.
Today, Acasti ships the purified omega-3s from France to Canada for encapsulation, sealing, and packaging by other manufacturing partners. “It would be nice to have all the steps under one roof,” Lemieux says. A one-shop process would further extend the Acasti-CordenPharma partnership and mean even more business for the once-unwanted plant in Chenôve.
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HomeDestinationsInterestsTop Places to Travel by MonthSearchMenuBest time to go to France
Grape cultivation and wine festivals constitute the tangible part of the French lifestyle
Save Visited Rate Review ShareSaumur winefields Clos MontmartreCollongette
Each region is famous for its own kind of wine
Harvest season may start as early as August
but it peaks in the months of September and October and continues into mid-November (the season differs and depends on the region)
Fall might not be the best for a wine tour as the cellars are going to be overcrowded
this is a perfect season to have an authentic experience of the harvest process and attend one of the grape-picking festivals
The Grape Harvest Proclamation is held in Saint Emilion in mid-September
The third weekend of September is marked by The Wine Pressing Festival
hosted by the village of Chenôve in the Côte d’Or region
you're invited to France's most famous Montmartre Grape Harvest Festival
Banyuls sur Mer Grape Harvest Festival is an alternative for the south-west
The Fete du Vin Bourru takes place in Nuits-Saint-Georges in late October
November has a nice celebration for the belated—you can celebrate new wine at Beaujolais Nouveau Wine Festival
held on the third Thursday of every November in the village of Beaujeu
the Grape Harvest Festival takes place at a magnificent Château de Saumur
a fortified stronghold of the past and a tourist attraction of the present
The structure has been surrounded by vineyards even back in the 14th century
increasing the historical significance of this celebration
the château is filled to the brim with entertainment for all ages and wine tastings
which marks the beginning of grape harvest
goes up on the King's tower and announces the harvest start
The custom dates back far back to the Roman rule
when the vineyard owners were prohibited from grape picking at their discretion and had to rely on the public's decision
This was done to ensure the quality of the harvest
with farmers choosing to start grape picking when they see fit
hidden from the public eye and closed for most of the year
the Parisians celebrate the harvest of their city's only vinery by throwing a grandiose outdoor bash all over the streets of Montmartre
The district is bustling with street performances
You may encounter some peculiar French customs
such as couli dripping showcase or a Cérémonie de non-mariage
where couples can express their appreciation for not being married
a commune of Nuits-Saint-Georges hosts a unique celebration of bourru wine
Somewhat in between grape juice and fully matured wine
the bourru wine still contains yeast and is quite cloudy due to an ongoing fermentation process
The festivities unfold at Les Halles de Nuits-Saint-Georges and feature grape pressing and an option to taste freshly pressed juice
Wine producers from all over France gather at the festival to treat attendees to some of their best wine varieties
you'll have a chance to listen to some local French music and browse the vendor section
where numerous art pieces and souvenirs are sold
Colin RandallJune 20
Lucille Pasquier
Le CèdreUn début d'année enchanté au Cèdre de Chenôve
Joyau culturel de l'agglomération de Chenôve à deux pas de Dijon
la salle de spectacle dévoile une programmation captivante pour le mois de janvier
Avec ses 692 places assises et 1100 places assises/debout
cette salle de spectacle à l’italienne promet des soirées inoubliables
Kicking off the year, le Cèdre accueille la talentueuse Lynda Lemay le vendredi 19 janvier
Accompagnée de sa voix envoûtante et de ses mélodies poignantes
elle promet une soirée empreinte d'émotions et de sincérité
Meurice & Lagadec : Vers l’infini (mais pas au-delà)
direction le Cèdre le samedi 20 janvier avec le duo comique Meurice & Lagadec
Leurs sketches hilarants et leur humour décalé garantissent une soirée pleine de rires et de bonne humeur
Une occasion parfaite pour décompresser après les festivités de fin d'année
mais qui se questionne sur les choses essentielles de la vie
il est la star montante de l’humour et accumule des millions d’abonnés et de vues sur les réseaux
où son personnage de la blonde est déjà culte.” - Le Cèdre
Plongez dans l'univers mystérieux de Dracula le samedi 27 janvier avec l’Orchestre National De Jazz
à découvrir une nouvelle histoire où l’on met de côté les cauchemars pour se laisser emporter par la musique.”- Le Cèdre
Clôturant le mois de janvier en beauté
le groupe déjanté Les Wriggles se produit le mardi 30 janvier
Leur énergie débordante et leurs performances scéniques uniques promettent une soirée inoubliable
Salle de spectacle - Le Cèdre 9 esplanade de la République - Chenôve Site Internet - Instagram - Facebook
Places en Musique : 6 concerts gratuits à ne pas rater en mai et juin
5 festivals pour fêter le printemps en musique
KamoCon 2025 : le rendez-vous incontournable des Geeks et Otakus à Dijon
The initial line of the Dijon Tramway System
the second line of the tramway opened in December 2012
Line T1 is 8.5km long and T2 is 11.5km long
The entire tramway system includes 37 stations
The tramway
was constructed by means of a public-private partnership involving Grand Dijon Urban Authority and Cofely Ineo
The Tramway System secured the 2012 best environmental project award
The Dijon tramway was completed with an investment of approximately $550m
The tramway construction generated approximately 6,700 jobs
The two lines are used by an estimated 87,000 people every day
The new tramway meets the travelling needs of the Greater Dijon population
The project is a primary element of the programme aimed at developing urban transportation infrastructure in an environmentally friendly manner
The tramway passes through several commercial zones in the city
Approximately 76,000 people reside within half a kilometre of the stations constructed along both the lines
The park-and-ride facility of the tram system is projected to minimise the volume of traffic in the city
by prohibiting cars on some specific roads
France is rapidly developing a world class high speed railway network
and the grand plan has been enhanced by the approval of a funding package worth €2.3bn for the first phase of the TGV Rhine-Rhone high speed line
Additionally, the Citadis tram set being used on the lines is designed to emit a low level of noise
which is five decibels quieter than that of average road traffic
The energy consumed by the tram sets is ten times les than buses
and even the greenhouse emission levels are much lower when compared with those of a car
There has been a growth in commercial activity of Dijon
which is the point where the T1 and T2 converge
is steadily developing as the new hub of Dijon
Several new restaurants and cafes have been opened along the tram line
The tram route runs through the city centre and several other locations in the vicinity of the main hospital
It also covers the residential and commercial zones of Chenove
The T1 passes through 16 stations starting from Dijon Railway Station to Quetigny
while T2 covers 21 stations of the Valmy- Chenove stretch
Interchanges are formed at the Dijon-Ville station to ensure that the passengers have convenient access to other means of transportation
Six shelters to park bicycles were provided at important stations
The tram sets running on the Dijon Tramway System are of the sophisticated Citadis family of Alstom
which are manufactured to provide maximum comfort to passengers
The Citadis tram sets feature integral low floors
closed-circuit video surveillance and passenger information systems
and can accommodate more than 200 passengers
The sets are designed to reach a top speed of 70km/h
The contract for supplying 33 tram sets for the Dijon Tramway System was awarded to Alstom
Cofely Ineo was selected to design and construct the electrical systems for the tramway
The contractor will also provide maintenance services for command systems and electrical equipment for 26 years
The European Investment Bank (EIB) provided approximately €200m ($262m) for the Dijon Tramway Project
The funding from EIB encompasses construction of T1 and T2
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