Novasep announced a € 4 million investment to expand c-GMP capacity for clinical and commercial supply of APIs at its Chasse-sur-Rhône facility in France.
Lyon/France — The investment includes the installation of a new c-GMP cryogenic production line, capable of operating at temperatures as low as -80 °C. It is equipped with a 4 m3 Hastelloy reactor, filter drier and clean room.
The investment also includes an expansion of the c-GMP pilot-plant capabilities with the addition of a new stream comprising a 400 L Hastelloy reactor, filter drier and clean room. According to the company, this will add flexible small-scale manufacturing capacity and reinforce the site’s capability to handle both clinical development needs and low volume APIs.
The investment will be operational by the beginning of 2018. The company’s total low temperature capacity will then reach more than 35 m3.
“By increasing cryogenics capacity at the current Chasse-sur-Rhône facility, we strengthen Novasep’s small and large-scale volume offering for low temperature manufacturing,” Jean-Pierre Pilleux, General Manager of the Chasse-sur-Rhône site said, adding that it would give the manufacturer more flexibility and allow them to address the increasing market demand for these types of capabilities.