Novasep (Pompey, France), a global provider of cost-effective and sustainable manufacturing services and technologies for life sciences molecules and fine chemicals will build a fully integrated Antibody Drug Conjugate (ADC) facility at its FDA-inspected Le Mans site in France. The site is currently certified by SafeBridge® for the synthesis and purification of Category 4 compounds.
Due to their high toxicity, payload manufacturing at industrial scale requires specifically designed facilities for contained production activities. The new facility will enable the company to complement its current ADC offering with full bio-conjugation services to meet increasing market demand.
The facility is planned to be commissioned in Q2 2016. It will provide contract manufacturing in batch sizes from a few milligrams to 600g to ADC drug developers during clinical trial and commercial development phases.
“Combining chemistry and biology is not a given. Novasep is one of the few CMOs able to produce both commercial scale ADCs payloads and monoclonal antibodies,” said Thierry Van Nieuwenhove, president of Novasep’s Synthesis Business Unit. “Customers are now searching for a simplified supply chain to produce their ADC and other bio-conjugate drug substances. By integrating our R&D, analytical and manufacturing services within a single unit, we can give customers flexibility, assurance of supply and continuity in supply chains.”
Back to basics
Novasep’s €10M investment in clinical and commercial scale ADC conjugation is a natural extension to its existing CMO offering and leverages its unique purification technologies. Novasep’s new ADC facility, whose design is now complete, will be capable of producing ADCs in full compliance with the highest standards in quality, health, environmental and industrial safety.
“This move is part of our “Back to basics” strategy, forging Novasep’s re-focus on growing core businesses,” explained Michel Spagnol, chairman and CEO of Novasep. “We are proud to see our Le Mans site continuing its growth in one of the pharmaceutical industry’s most exciting development areas.”