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), adenovial (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.