CEVEC just filed a Biologics Master File (BB-MF) to the FDA for its CAP technology, which outperforms all current standards in the production of gene therapy vectors and glycosylated human proteins.
CEVEC is a Biotech with the mission of raising the industrial standard for the large-scale production of glycosylated proteins, viral vaccines and gene therapy vectors. CEVEC has submitted the Biologics Master File (BB-MF), which describes in detail the CAP technology, its establishment, development and potential uses to produce biologics.
This is a key milestone that will make it really easy for its licensees to use the technology that encompasses several cell lines. These can be applied to tailored applications with the main advantage of being scalable to unprecedented amounts. The cells are more robust and documented in much greater detail than other common cell lines like CHO or HEK 293, which makes them perfect for industrial applications.
CEVEC has two CAP platforms: CAP-GT and CAP-Go. CAP-GT produces viral vectors on a large scale with no risks of obtaining replicable viruses, whereas common cell lines may produce small amounts of functional viruses such as Adenoviruses that make them unsafe. The technology has the potential to improve and scale-up gene therapy, which, despite regulatory challenges, is starting to resurge with companies like Genenta, BrainVectis, GSK, UniQure, GenSight or MolMed.
For its part, the CAP-Go technology is used to obtain recombinant proteins with superior glycosylation profiles as compared to other cell lines. For example, CEVEC can produce various coagulation factors with significantly increased half-life. The company has also partnered up with BioLamina and CellGenix to provide them with essential proteins for cell therapy applications.
In a chat with us, CEVEC’s CSO emphasized that the technology will be easily accessible to licensees, with both in-house and contract manufacturing options. The submitted BB-MF simplifies and accelerates the IND process of CEVEC´s clients as the regulatory relevant data on the CAP technology is already deposited at the FDA. These advantages put the company on the right track to replace current industry standards.
Featured image: Alexander Tolstykh
Figure courtesy of CEVEC