Novasep Commissions $5.5M Plant Extension

By PhM Staff

May 16, 2014

Novasep announced that it has made a $5.5M investment to expand the company’s highly potent active pharmaceutical ingredients (HPAPI) manufacturing capabilities at its Le Mans facility in France. The plant extension has been fully qualified and is now being used to scale up validation of a commercial antibody drug conjugate (ADC) payload.

“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.”

HPAPI, says Novasep, are used in anti-cancer therapies and must be produced under very strict regulatory conditions to prevent API substances from cross contaminating other lines as well as to protect operators from the highly active properties intrinsic to such compounds. Contract Manufacturing Organizations (CMOs), says the company, 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.

Novasep’s Le Mans plant, notable for its production of highly potent cytotoxic pharmaceutical ingredients and registered advanced intermediates, recently passed a US Food and 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 installed in confined areas, says Novasep, 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 designed and built.