27. October 2016 MM

CEVEC submits Biologics Master File (BB-MF) for CAP(R) Technology to the U.S. FDA

  • Submission represents an important step towards establishing CAP(R)GT and CAP(R)Go technologies as the new industrial standards for viral vaccines, commercial-scale gene therapy vectors and recombinant protein production
  • CEVEC’s CAP(R) technology licensees can reference BB-MF, simplifying and accelerating their regulatory approval process for a CAP(R)-derived product.

Cologne. 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(R) 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(R) technology and the manufacturing process of the CAP(R) 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(R) 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.”

About CEVEC:

CEVEC is a center of expertise for the production of biopharmaceuticals using a unique human cell-based expression system. CAP(R)GT is an expression platform for scalable viral vector production. CAP(R)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(R)GT enables better scale-up and competitive production costs when compared to adherent cell culture systems.

CAP(R)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.

Contact:

CEVEC Pharmaceuticals GmbH
MC Services AG
Frank Ubags
Chief Executive Officer
T.:+49 221 46020800
E.: ubags@cevec.com

MC Services

Anne Hennecke

T.: +49 211 52925222
E.: anne.hennecke@mc-services.eu

Press release Cevec_FDA_Filing