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

DGAP-News: CEVEC Pharmaceuticals GmbH / Key word(s): Study
CEVEC submits Biologics Master File (BB-MF) for CAP(R) Technology to the
U.S. FDA

27.10.2016 / 08:30
The issuer is solely responsible for the content of this announcement.

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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, 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(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.

More information: www.cevec.com

Follow CEVEC on LinkedIn.

Contact:      

<pre>
CEVEC Pharmaceuticals GmbH      MC Services AG
Frank Ubags                     Anne Hennecke
Chief Executive Officer         Public Relations
T.:+49 221 46020800             T.: +49 211 52925222
E.: ubags@cevec.com             E.: anne.hennecke@mc-services.eu
www.cevec.com









</pre>


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27.10.2016 Dissemination of a Corporate News, transmitted by DGAP - a
service of EQS Group AG.
The issuer is solely responsible for the content of this announcement.

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