CEVEC introduces CAP®GT cell-expression system for scalable viral gene therapy vector production
Cologne, Germany, September 7, 2015
CEVEC Pharmaceuticals GmbH (CEVEC), the expert in the production of tailor-made recombinant glycoproteins and gene therapy vectors, today announced the introduction of its unique cell-expression system, CAP®GT for the fully scalable production of gene therapy vectors, based on the Company’s proprietary CAP® technology.
CAP®GT technology – Scalable gene therapy vector production
With CAP®GT cell lines, CEVEC provides a novel platform for the industrial production of viral vectors for gene therapy applications. CAP®GT cells propagate a broad spectrum of viral species supporting lentiviral (LV), adenoviral (AV) and adeno-associated viral (AAV) vectors.
Growing in serum-free suspension culture, the CAP®GT expression system provides high cell densities, reduces production costs, and allows for safer and more efficient scale-up when compared to adherent cell culture systems. As demonstrated in adenoviral vector production runs, the CAP®GT platform offers the significant advantage over HEK293 cells, that no replication competent adenovirus (RCA) can be detected in the vector preparation. Independent study results indicate that CAP®GT derived lentiviral vector production results in vector titers comparable to or even exceeding production with HEK293 cells. Given the easy scale up of the CAP®GT suspension cell lines, industrial scale production is feasible.
“The superior features in terms of production efficiency of the expression system and safety of CAP®GT-derived viral vectors provide CEVEC with clear competitive advantages and position the CAP®GT Technology at the leading edge of the rapidly growing field of gene therapy vector manufacturing,” commented Frank Ubags, Chief Executive Officer of CEVEC Pharmaceuticals GmbH.
CEVEC’s CAP®GT technology meets necessary regulatory requirements. Derived from a non-tumor human origin, the cell line was developed according to industrial standards with complete documentation and full certification of materials. A master file is currently in process to be submitted for approval to the US Food and Drug Administration (FDA).
One of the biggest challenges in gene therapy today that is still preventing this innovative form of treatment from commercial usage is the ability to produce, on an industrial scale, reliable and safe vectors that carry the DNA molecules to the target cells. CEVEC’s CAP®GT expression platform addresses this unmet need and enables the commercial production of gene therapy treatments.
Privately held CEVEC, based in Cologne, Germany, is an expert for the production of tailor-made recombinant glyco-proteins and gene therapy vectors. The Company’s core technologies, CAP®Go and CAP®GT are based on a unique human cellular expression system.
The CAP®Go expression platform comprises a portfolio of glyco-optimized human suspension cell lines for tailor-made glycosylation of recombinant proteins. The cells are highly efficient for the production of a broad range of difficult to express glycoproteins and provide authentic human post-translational modifications. CAP®Go has proven to enhance the activity, stability and serum half-life of several candidate proteins.
The CAP®GT expression platform provides a fully scalable, regulatory endorsed production system for gene therapy vectors. CAP®GT cells grow to high cell densities and show a broad viral propagation spectrum including lentivirus (LV), adenovirus (AV) and adeno-associated virus (AAV). Furthermore, CAP®GT enables easier scale-up and reduced production costs when compared to adherent cell culture systems.
Research collaborations with international pharmaceutical and biotechnology partners followed by licensing agreements for the technology form one revenue base for CEVEC. In addition, the Company provides contract manufacturing for the cGMP production in CAP®Go and CAP®GT cells.
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