Novasep gets FDA OK for HPAPI expansion in France

Novasep plant in Le Mans, France--Courtesy of Novasep

French contract manufacturer Novasep says that its expansion of its highly potent active pharmaceutical ingredients (HPAPI) manufacturing operations at its plant in Le Mans, France, is complete, signed off on by the FDA and now being scaled up for commercial use.

Novasep invested €4 million ($5.5 million) on the project, which combines chemical and purification capabilities to manufacture potent and extremely potent antibody-drug conjugate (ADC) commercial-scale payloads. "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.

As the company points out, demand has been rising for HPAPI, which primarily are used in targeted cancer treatments. They have to be produced under strict regulatory conditions to protect against cross-contamination of APIs and ensure the safety of operators. A number of third-party manufacturers have been investing in a variety of resources to win business in the category. Swiss ingredient maker Lonza said last year it would double ADC capacity at its plant in Visp, Switzerland, and Dutch drugmaker Synthon opened an ADC manufacturing facility to serve its own needs and its partnerships.

Swiss drugmaker Roche ($RHHBY), the largest developer and maker of cancer drugs, is having big success with its targeted cancer drugs like Perjeta and Kadcyla for treating HER2-positive breast cancer. Kadcyla is Roche's first approved ADC, but it has 8 others under development. Anticipating more approvals and big demand, Roche is spending 190 million Swiss francs ($208.9 million) on a new ADC production facility in Basel. That project is part of an $880 million expansion of its biologics manufacturing capabilities across its entire manufacturing network.

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