CEVEC submits Biologics Master File (BB-MF) for CAP® Technology to the U.S. FDA
- Submission represents an important step towards establishing CAP®GT and CAP®Go technologies as the new industrial standards for viral vaccines, commercial-scale gene therapy vectors and recombinant protein production.
- CEVEC’s CAP® technology licensees can reference BB-MF, simplifying and accelerating their regulatory approval process for a CAP®-derived product.
Cologne, Germany, October 27, 2016
CEVEC Pharmaceuticals GmbH (CEVEC), the expert in the production of tailor-made recombinant glycoproteins and gene therapy vectors, today announced that is has submitted a Biologics Master File (BB-MF) for its human cell substrate CAP® to the U.S. Food and Drug Administration’s (FDA) Center for Biologics Evaluation and Research (CBER).
The BB-MF is a detailed dossier submitted to the FDA which contains confidential and proprietary information regarding the CAP® technology and the manufacturing process of the CAP® cell line.
Frank Ubags, Chief Executive Officer of CEVEC Pharmaceuticals GmbH, commented: „The submission of the Biologics Master File to the U.S. FDA is an important milestone as we seek to establish our CAP® technology as the new standard for industrial-scale production of gene therapies, protein-based therapeutics and vaccines worldwide. Our human cells of non-tumor origin are among the best documented cell lines available today for biopharmaceutical production purposes. This referenceable BB-MF will strongly support our customers when seeking regulatory approval for their CAP-derived biopharmaceutical clinical product candidates.“
CEVEC is a center of expertise for the production of biopharmaceuticals using a unique human cell-based expression system.
CAP®GT is an expression platform for scalable viral vector production. CAP®GT suspension cells grow to high cell densities and show a broad viral propagation spectrum. Gene therapy vectors such as lentivirus (LV), adenovirus (AV) and adeno-associated virus (AAV) can be produced at industrial scale. CAP®GT enables better scale-up and competitive production costs when compared to adherent cell culture systems.
CAP®Go enables the production of proteins previously out of reach. The expression platform comprises a portfolio of glyco-optimized human suspension cell lines for tailor made glycosylation of recombinant proteins. The cells highly efficiently produce a broad range of difficult to express glycoproteins and provide authentic human post-translational modifications.
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