The expansion has been designed to allow Novasep to serve the increased demand for manufacturing of novel anti-cancer therapies.
Demand in the pharmaceutical industry has sharply increased for the manufacture of targeted and potent drugs that improve efficacy and reduce side effects, such as antibody-drug conjugates (ADCs). The new Novasep Le Mans facility adds to Novasep’s global strategy for total synthesis of 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 -60°C in hastelloy reactors, large-scale HPLC chromatography and drying in confined areas to manufacture ADC toxins at commercial scale. The plant expansion is expected to be fully operational by the beginning of 2013. In its expanded cGMP facility, Novasep will be able to perform the synthesis, purification and isolation of extremely potent compounds with an OEL (occupational exposure limit) lower than 30 ng/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, whilst the economic climate demands more cost-effective and safe solutions,” says 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 today 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.”