GMP Manufacture for clinical applications and Licensing
CEVEC provides access to GMP compliant MCB, upstream & downstream production services for CAP-Go derived recombinant protein and CAP-GT derived viral vector applications.
Subject to the execution of an individualized commercial license, CEVEC assists to select the appropriate CDMO partner enabling a smooth technology transfer. For dossier filings with regulatory agencies, CEVEC provides CAP related support.
For further information please contact us at:
or call us under +49-221-4602-0800
CAP® Technology Access
At our Cologne R&D facilities we typically perform vector construction, stable pool generation and lab scale production of supernatants. Subsequent development steps towards industrial scale production include the generation of high performing single cell clones, USP, DSP and analytical development to optimize product yield and quality. More details regarding our broad CAP-Go related manufacturing services can be found here.
First viral gene therapy vector production studies are typically performed as small scale transient transfection experiments in our CAP-GT platform in our BSL-2 laboratories in Cologne. Subsequent process optimizations or the generation of stable packaging and producer cell lines are tailored to the specific needs of each customer under R&D collaboration agreements. Additional information regarding our CAP-GT related manufacturing capabilities are described here.