Novasep, a Lyon, France-headquartered contract manufacturing organization and life-science service provider, is investing EUR 4 million ($4.6 million) to expand cGMP capacity at its facility in Chasse-sur-Rhône, France for clinical and commercial supply of active pharmaceutical ingredients (APIs).

The investment includes the installation of a new cGMP cryogenic production line, capable of operating at temperatures as low as -80 degrees Celsius as well as a 4-cubic-meter Hastelloy reactor, filter drier, and cleanroom.

The investment also includes an expansion of cGMP pilot-plant capabilities with the addition of a new stream comprising a 400-liter Hastelloy reactor, filter drier, and cleanroom. This investment adds small-scale manufacturing capacity and reinforces 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 35 cubic meters.

Source: Novasep