Novasep, a global provider of cost-effective and sustainable solutions to produce active molecules at the required purity to the life sciences industries, announced a Euro three million investment to expand its Highly Potent API (HPAPI) manufacturing capabilities at its facility in Le Mans, France. 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 comprehensive 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 minus 60 degrees 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.
The experience of the Le Mans personnel in synthesis and purification of HPAPIs, as well as the investment over 25 years at the site, has enabled Novasep to position itself at the forefront of ADC toxins manufacturing. This extensive experience at this site alone has led to SafeBridge(R) certification since 2009 and passing several FDA inspections.
“Manufacturing for the life science sectors is facing a series of challenges. Drug candidates become more specific and personalized, whilst 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 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.”
“With this new important investment in our HPAPI capacity in Le Mans, Novasep confirms its willingness to continue developing its global, differentiated and value-adding business model,” said Roger-Marc Nicoud, Novasep’s founder and CEO.