Will be able to perform the synthesis, purification and isolation of extremely potent compounds
Novasep, a French supplier of manufacturing services to the life sciences, is investing €3m to expand its Highly Potent API (HPAPI) manufacturing capabilities at its facility in Le Mans, France, to meet increased demand for anti-cancer drugs.
The new facility will add to Novasep’s strategy to offer total synthesis of antibody drug conjugates (ADCs), including toxin and monoclonal antibodies (mAb) production, mAb-toxin coupling, downstream processing and formulation.
In the new facility, Novasep will be able to perform cryogenic chemistry at –60ºC in hastelloy reactors, large-scale HPLC chromatography and drying in confined areas to manufacture ADC toxins at commercial scale.
The plant expansion, which is expected to be fully operational by 2013, will enable Novasep to perform the synthesis, purification and isolation of extremely potent compounds with an OEL (occupational exposure limit) lower than 30ng/m3 at multi-kg scale per batch.
‘Manufacturing for the life science sectors is facing a series of challenges. Drug candidates become more specific and personalised, while the economic climate demands more cost-effective and safe solutions,’ said Patrick Glaser, head of Novasep Synthesis, the synthetic molecule division of Novasep.
‘Novasep’s development strategy has enabled us to anticipate these changes in the market and we are increasing our capability to meet future market demand; this new investment is the result of our continued commitment in HPAPI and our long-term collaboration with our customers.’