Eurofins Amatsigroup doubles capacity in Clinical Trial Supply activities, including new Cold Chain Facilities, in response to increasing demands of bio/pharmaceutical products
Eurofins Amatsigroup has pledged significant investments to expand its European facility of Saint Gely du Fesc (FR) dedicated to Clinical Packaging and Logistics for bio/pharmaceutical customers.
Fontenilles, FR, November 16, 2017
Eurofins Amatsigroup, a leading European Contract Development & Manufacturing Organization (CDMO) located in France, announces today the expansion of its Clinical Trial Supply activities through major investments in its Saint Gély du Fesc (FR) site, which specializes in Packaging & Logistics for human and veterinary drug products.
After the extension of its manufacturing areas in 2016, the site of Saint Gély du Fesc continues to further enhance its development by optimizing and doubling its Clinical Trial Supply capacities.
The new building has been designed to streamline the flow of drug products from the reception to the distribution area to make it faster, in particular for products sensitive to temperature change. The facility will house seven Packaging Suites. Two secondary Packaging Rooms at 2-8°C will be directly connected to the temperature-controlled storage area (2-8°C) to allow products to remain at the appropriate temperature during all the labeling and packaging processes. This enables products to be directly picked up in the cold chamber for shipment. All Cold Storage areas will be secured by an emergency power (generator). And this facility will be fully monitored (24 hours/7).
The facility will add 1,200 m2 of surface expansion (12,900 ft2), including GMP storage capacity of 2,500 m3 (88,200 ft³) at 15-25°C and 220 m3 (7,700 ft³) at 2-8°C. With these new capacities, the facility in Saint Gely du Fesc will gain flexibility for small and large size batches (Phase 1 to 3 clinical trials), and will be able to manage the challenge of temperature sensitive products, such as Biologicals. It reinforces Eurofins Amatsigroup’s portfolio of services in line with the large range of primary packaging capabilities offered on site, including blistering for capsules, tablets, vials, syringes and bottles.
“With the new capacities of storage, Eurofins Amatsigroup is positioned as a partner for depot activities, including project management, importation, storage, packaging, labeling and worldwide distribution to clinical sites,” added Stéphane Bronner, Site Director of Saint Gély du Fesc.
In parallel with this facility extension, Eurofins Amatsigroup strengthens its technical and project management teams to support the growing business while continuing to improve the quality of services and to provide client-oriented solutions.
Those new capacities will be fully operational end of 2017.
Eurofins Amatsigroup CTS integrated services encompass:
- Project management,
- Primary & secondary packaging
- Clinical labeling
- Sourcing of comparators
- Worldwide distribution (50 countries already covered)
- Management of returns and destruction