Novasep, a leading supplier of services and technologies for the life sciences industry, today announced a €4M investment to expand cGMP capacity for clinical and commercial supply of APIs at its Chasse-sur-Rhône facility in France.
The investment includes the installation of a new cGMP cryogenic production line, capable of operating at temperatures as low as -80°C. It is equipped with a 4m3 Hastelloy reactor, filter drier and clean room.
The investment also includes an expansion of the cGMP pilot-plant capabilities with the addition of a new stream comprising a 400L Hastelloy reactor, filter drier and clean room. 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. Novasep’s total low temperature capacity will then reach more than 35m3.
“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, “It will give us more flexibility and allow us to address the increasing market demand for these types of capabilities.”
As a CDMO, Novasep has a 30-year track-record in the scale up, validation and commercial supply of low-temperature chemistry under cGMP. These new facilities will enable Novasep to handle highly reactive compounds such as organometallic reagents and improve the selectivity of reactions.