Novasep Boosts Manufacturing Capacity At Le Mans Facility
Novasep announced that it invested $5.5 million to increase the manufacturing capacities at its Le Mans facility in France, and that the plant is now fully qualified. The investment has expanded the company’s ability to manufacture highly potent active pharmaceutical ingredients (HPAPI). The new extension to the facility is now being used to scale up an antibody drug conjugate (ADC) payload.
Producing HPAPI is a difficult undertaking given the stringent regulations regarding the manufacture of API substances. APIs must be protected from cross contamination and operators must also be protected from the highly active properties found in the drugs being produced. Increasing regulatory measures mean that contract manufacturers must remain diligent and continue to upgrade facilities to meet new regulations as well as increase production capacity.
Thierry Van Nieuwenhove, President of the Synthesis Business unit at Novasep, says, “We are pleased to see the Le Mans facility commissioned, fully operational, and successfully FDA audited,” he said. “There is a high demand from the pharmaceutical industry for CMOs to manufacture potent molecules for use in drugs that improve efficacy and reduce side effects. Novasep has the development and manufacturing capacity, level of specialization and experience to safely address the needs of this market.”
This news comes several years after the company announced it would be investing 30 million euros to build the world’s largest chromatography plant used in the production of APIs at its Mourenx site. The company used the facility to increase its purification-based manufacturing capabilities. Patrick Glaser, President and CEO of Novasep, released a statement on the construction of the facility back in 2012. “Demand for Novasep’s advanced, purification-based manufacturing capabilities in the life science industries continues to increase as drugs in development and reaching the market become more complex and specific. This necessitates our third, and largest global plant expansion in 2012,” he said.