Novasep, supplier of services and technologies for the life sciences industry, has announced a €4m ($4.8m) investment to expand cGMP (current good manufacturing practice) capacity for clinical and commercial supply of active pharmaceutical ingredients (APIs) at its Chasse-sur- Rhône facility.
The investment includes the installation of a new cGMP cryogenics production line, capable of operating at temperatures as low as -80℃. There will also be expanded 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.
Jean-Pierre Pilleux, General Manager of the Chasse-sur-Rhône site said, “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.” He continued, “It will give us more flexibility and allow us to address the increasing market demand for these types of capabilities”.
As a contract development and manufacturing organisation (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.
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