Dr Michel Spagnol, chairman and CEO, Novasep. (File photo)
POMPEY, FRANCE: Novasep Holding SAS said it will build a fully integrated, new antibody drug conjugate (ADC) facility at its Le Mans site in France, complementing its current ADC offering with full bio-conjugation services to meet increasing market demand.
Novasep’s €10 million investment in clinical and commercial scale ADC conjugation is a natural extension to its existing CMO offering and leverages its unique purification technologies. Novasep’s new ADC facility design is now complete, it said.
The facility to be commissioned in second quarter of 2016, will provide contract manufacturing in batch sizes from a few milligrams to 600g to ADC drug developers during clinical trial and commercial development phases.
“Combining chemistry and biology is not a given. Novasep is one of the few CMOs able to produce both commercial scale ADCs payloads and monoclonal antibodies,” said Thierry Van Nieuwenhove, president, Novasep’s synthesis BU. “Customers are now searching for a simplified supply chain to produce their ADC and other bio-conjugate drug substances. By integrating our R&D, analytical and manufacturing services within a single unit, we can give customers flexibility, assurance of supply and continuity in supply chains,” he added.
“This move is part of our “Back to basics” strategy, forging Novasep’s re-focus on growing core businesses. We are proud to see our Le Mans site continuing its growth in one of the pharmaceutical industry’s most exciting development areas,” said Dr Michel Spagnol, chairman and CEO, Novasep.
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