Novasep has announced that its EUR 4 million (USD 5.5m) investment to expand its highly potent active pharmaceutical ingredients (HPAPI) manufacturing capabilities at its Le Mans facility in France has reached fruition. The plant extension has been fully qualified and is now being used to scale up validation of a commercial ADC (antibody drug conjugate) payload.
HPAPI, the majority of which are used in anti-cancer therapies, must be produced under very strict regulatory conditions to protect any API substance from cross contamination and protect operators from the highly active properties that are intrinsic to these products.
Contract Manufacturing Organizations (CMOs) increasingly need to upgrade their facilities with higher containment capabilities. Ensuring supply chain continuity is also important to meet the rising demand in the pharmaceutical industry for ADCs.
“We are pleased to see the Le Mans facility commissioned, fully operational and successfully FDA audited,” said Thierry Van Nieuwenhove president of the Synthesis Business unit at Novasep. “There is a high demand from the pharmaceutical industry for CMOs to manufacture potent molecules for use in drugs that improve efficacy and reduce side effects. Novasep has the development and manufacturing capacity, level of specialization and experience to safely address the needs of this market.”
Novasep’s Le Mans plant, notable for producing highly potent cytotoxic pharmaceutical ingredients (APIs) and registered advanced intermediates, recently passed US FDA (Federal Drug Administration) inspection.
The Le Mans production facility combines chemical and purification capabilities to manufacture potent and extremely potent ADC payloads at commercial scale with an OEL (occupational exposure limit) lower than 30 ng/m3 at multi-kg scale per batch.
On top of the classical chemical features in installed confined areas, the production suite can perform cryogenic chemistry at minus 60 degrees Celsius in hastelloy reactors.
The purification suite is equipped with a Prochrom® industrial High-Performance Liquid Chromatography (HPLC) system, which Novasep in Pompey designed and built.