In 1997, Flamel Technologies acquired a manufacturing facility in Pessac, near Bordeaux (France). 
Across the years, several extension projects were conducted and led to a modern, up-to-date 9,700 square meters premises.
The site is approved by the AFSSAPS (French agency of medical safety for health products) and the FDA. The products and processes developed on the site are in compliance with European as well as US guidelines concerning manufacturing (BPF, GMP, cGMP). The site is also in compliance with the AFSAPPS’ good manufacturing practices for excipient manufacturing.
A number of tasks are specifically conducted on the manufacturing site in connection to:
-
Medusa drug delivery platform
- Polymer synthesis: development laboratory and GMP batches production (two pilot facilities from 10 to 600 liters glass-line reactor, diafiltration unit up to 24 m² membrane surface, in classified area, with ICHQ7A agreement for pharmaceutical excipient).
- Injectable form development: specific manufacturing process design, process and product optimization (from lab scale to large scale to support clinical Phase I/II studies), GMP regulatory and clinical batches through CMO (Contract Manufacturing Organisation) management.
- Oral forms, including Micropump drug delivery platform
- clinical manufacturing.
- commercial scale-up / manufacturing ( 3 spray coaters with closed loop allowing organic solvent use).
- contract manufacturing (Coreg CR microparticles for GSK).
Through these activities, Flamel Technologies has also developed analytical development and pharmaceutical analysis expertise and tools:
- Analytical method: development, optimization and validation.
- Stability program for regulatory, clinical and commercial batches.
- QC (Quality Control) of raw materials, packaging material, in process control and finished product.
