Novasep expanded its 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.
HPAPI, the majority of which are used in anti-cancer therapies, must be produced under 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. Ensuring supply chain continuity is also important to meet the rising demand in the pharmaceutical industry for ADCs. “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," said Thierry Van Nieuwenhove, president of the Synthesis Business unit at Novasep.
The Le Mans production facility combines chemical and purification capabilities to manufacture potent and extremely potent ADC payloads at commercial scale with an occupational exposure limit lower than 30 ng/m3 at multi-kg scale per batch. The production suite can also perform cryogenic chemistry at -60 °C in Hastelloy reactors.