New HPAPI manufacturing capacity at the Le Mans facility will boost Novasep’s ability to meet customer demand for producing anticancer therapies
Novasep's €4m (US$5.5m) investment to expand the highly potent active pharmaceutical ingredients (HPAPI) manufacturing capabilities at its Le Mans facility in France has reached completion. The plant extension has been fully qualified and is now being used to scale up validation of a commercial ADC (antibody drug conjugate) payload.
The Le Mans plant, notable for producing highly potent cytotoxic APIs and registered advanced intermediates, recently passed a US FDA inspection. The 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 30ng/m3 at multi-kg scale per batch.
In addition to the classical chemical features in installed confined areas, the production suite can perform cryogenic chemistry at -60°C in hastelloy reactors. The purification suite is equipped with a Prochrom industrial HPLC system, which was designed and built by Novasep in Pompey.
'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 specialisation and experience to safely address the needs of this market.'