Novasep has received the regulatory nod to manufacture a kinase inhibitor new molecular entity (NME) following pre-approval inspections at two facilities in France.
The US Food and Drug Administration (FDA) inspected Novasep’s Chasse-sur-Rhone and Pompey sites last month and has certified the contract manufacturer to produce a new molecular entity (NME) already approved in the US.
The NME is for a small molecule kinase inhibitor – a type of enzyme inhibitor which stops phosphorylation and can therefore help treat certain cancers and inflammatory diseases – but the firm was unable to disclose further details due to client confidentiality.
However, Sophie Baudouin, Marketing Director at Novasep, did tell Outsourcing-Pharma.com that on top of acknowledging the sites’ cGMP, the approval “positions Novasep as a top tier leader providing services to the Pharmaceutical industry.”
She continued: “To have the technologies and the capacity to produce is not always enough either,” adding the firm’s “level of compliance with regulations, proven over the years” was also a key in being selected by the client for this project.
The API and late-stage intermediates will be made at the Chasse-sur-Rhone site, which has multi-step pilot and commercial scale production workshops, Baudouin said, offering “specialized technologies such as ozonolysis, low temperature, enzymatic reactions, metal catalyzed coupling reactions” on top of conventional synthesis technologies.
Pompey will be used for the last purification step, she continued, using Novasep’s industrial chromatography platform designed and produced on site.
In 2013, Novasep’s Le Mans, Mourenx (both in France) and Leverkusen (Germany) were also subject to successful FDA inspections .