The plant’s expansion means that it’s now fully qualified to scale up validation of a commercial ADC (antibody drug conjugate) payload.
Novasep’s Le Mans plant, notable for producing highly potent cytotoxic pharmaceutical ingredients and registered advanced intermediates, also recently passed a US FDA 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 -60 degrees Celsius in hastelloy reactors. The purification suite is equipped with the company’s proprietary Prochrom industrial High-Performance Liquid Chromatography system, which Novasep designed and built.
HPAPI, the majority of which are used in anti-cancer therapies, must be produced under strict regulatory conditions to protect from cross contamination. CMOs such as Novasep increasingly need to upgrade their facilities with higher containment capabilities to protect operators.
In 2012, Novasep also invested €3m to scale up its ADC units in France. The company also recently reported 14% growth for its biopharma business, driven by increases in sales of equipment and biomanufacturing.
“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.”