Novasep Invests €3 Million to Boost its HPAPI Manufacturing Capabilities

Novasep, a supplier of manufacturing solutions to the life sciences industries, announces today a €3 million investment to expand its Highly Potent API (HPAPI) manufacturing capabilities at its Le Mans (France) facility. 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 Le Mans facility adds to Novasep's comprehensive global strategy for total synthesis of ADCs, including toxin and monoclonal antibody (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 as well as 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.