CAP®GT technology for fully scalable industrial adenoviral vector production with proven absence of replication-competent adenovirus (RCA)
? CAP®GT technology is underway to replace HEK293 as current production host for adenoviral vectors Cologne, Germany, May 10, 2016 - CEVEC Pharmaceuticals GmbH (CEVEC), the expert in the production of tailor-made recombinant glycoproteins and gene therapy vectors, today announced that the Company’s proprietary cell-expression system, CAP®GT, has delivered the production of safe adenoviral (AV) gene therapy vectors with the proven absence of RCAs.
For most adenoviral-based gene therapy applications, adenoviral vectors are modified in such a way to deliver the gene of interest to the target cell but cannot replicate within the cells of the patient. The commonly used producer cell line for vector production, HEK 293, bears the inherent risk of accidentally generating, by homologous recombination, replication-competent adenoviruses. The absence of RCAs in clinical production lots can only be proven through intensive testing in order to eliminate the risk of involuntarily spreading the infective vector.
CEVEC’s CAP®GT prohibits the formation of RCAs as the CAP cells do not allow homologous recombination events to occur with the AV vector genome. No RCAs are found in 5 x 1010 virus particles (VP) of CAP®GT-derived adenoviral vectors, whereas adenoviral vector preparations from HEK293 cells contain 5-500 RCAs per 1010 VPs. RCA was measured using an in vitro assay. The observed titers in the CAP®GT derived adenoviral vector production results matched and exceeded titers seen in production when using HEK293 cells.
“We have delivered superior results with the production of CAP®GT-derived adenoviral vectors,” commented Frank Ubags, Chief Executive Officer of CEVEC Pharmaceuticals GmbH. “The advantages in terms of safety and productivity as well as the easy industrial scale up of the CAP®GT suspension cell lines create an unique position in gene therapy vector manufacturing with the clear goal to replace HEK293 as the current production host.”
CEVEC’s CAP®GT technology meets the necessary regulatory requirements. Derived from a non-tumor human origin and grown in serum-free suspension culture, 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 to the US Food and Drug Administration (FDA).
About CEVEC:
CEVEC is a center of expertise for the production of biopharmaceuticals using a unique human cell-based expression system. CAP®GT is a regulatory endorsed 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.
? CAP®GT technology is underway to replace HEK293 as current production host for adenoviral vectors Cologne, Germany, May 10, 2016 - CEVEC Pharmaceuticals GmbH (CEVEC), the expert in the production of tailor-made recombinant glycoproteins and gene therapy vectors, today announced that the Company’s proprietary cell-expression system, CAP®GT, has delivered the production of safe adenoviral (AV) gene therapy vectors with the proven absence of RCAs.
For most adenoviral-based gene therapy applications, adenoviral vectors are modified in such a way to deliver the gene of interest to the target cell but cannot replicate within the cells of the patient. The commonly used producer cell line for vector production, HEK 293, bears the inherent risk of accidentally generating, by homologous recombination, replication-competent adenoviruses. The absence of RCAs in clinical production lots can only be proven through intensive testing in order to eliminate the risk of involuntarily spreading the infective vector.
CEVEC’s CAP®GT prohibits the formation of RCAs as the CAP cells do not allow homologous recombination events to occur with the AV vector genome. No RCAs are found in 5 x 1010 virus particles (VP) of CAP®GT-derived adenoviral vectors, whereas adenoviral vector preparations from HEK293 cells contain 5-500 RCAs per 1010 VPs. RCA was measured using an in vitro assay. The observed titers in the CAP®GT derived adenoviral vector production results matched and exceeded titers seen in production when using HEK293 cells.
“We have delivered superior results with the production of CAP®GT-derived adenoviral vectors,” commented Frank Ubags, Chief Executive Officer of CEVEC Pharmaceuticals GmbH. “The advantages in terms of safety and productivity as well as the easy industrial scale up of the CAP®GT suspension cell lines create an unique position in gene therapy vector manufacturing with the clear goal to replace HEK293 as the current production host.”
CEVEC’s CAP®GT technology meets the necessary regulatory requirements. Derived from a non-tumor human origin and grown in serum-free suspension culture, 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 to the US Food and Drug Administration (FDA).
About CEVEC:
CEVEC is a center of expertise for the production of biopharmaceuticals using a unique human cell-based expression system. CAP®GT is a regulatory endorsed 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.
