Novasep gained FDA approval last year for an expansion of its highly potent active pharmaceutical ingredients (HPAPI) capabilities at its plant in Le Mans, France. Now the French contract manufacturer is planning to build a facility there capable of manufacturing antibody-drug conjugates (ADCs).
The company today said it will spend €10 million ($11.2 million) on the new plant at LeMans, which it expects to be ready in the second quarter of 2016. The facility will be able to handle clinical supply through commercial scale production with batch sizes ranging from a few milligrams to 600 g.
|Thierry Van Nieuwenhove|
"Combining chemistry and biology is not a given," Thierry Van Nieuwenhove, president of Novasep's Synthesis BU, said in a statement. "Novasep is one of the few CMOs able to produce both commercial scale ADCs payloads and monoclonal antibodies."
The company said that the investment in ADC conjugation was a natural extension to the capabilities the LeMans facility already has. The company earlier invested €4 million ($5.5 million) to expand its HPAPI capacity, combining its chemical and purification capabilities to manufacture potent and extremely potent ADC commercial-scale payloads.
ADCs, which link cell-targeting monoclonal antibodies (mAbs) to cytotoxic drugs, are increasingly used to develop targeted cancer drugs. This immuno-oncology is one of the hottest categories of R&D right now. Not only are companies developing new mAbs, but older versions are now being developed into biosimilars, which are expected to significantly expand the demand for ADC manufacturing.
- here's the release