CAP®Ad – A Versatile Platform for RCA-free, Industrial Scale Adenoviral Vector Production

Adenoviral vectors are frequently used as gene delivery tools for various medical applications. In most cases, replication-incompetent adenoviruses are employed, which, once they have infected a target cell, cannot spread further in the patient‘s body. In such applications, regulatory guidelines require that the formation of replication-competent adenoviruses (RCA) in the production process must be minimized. Since the risk of RCA occurrence depends on the adenoviral vector and the cell line used for generating the virus stock and for manufacturing the vector at large scale, the choice of an appropriate cell line and production platform is a critical decision at the beginning of each project. Ideally, it should allow, among other things, easy, scalable and GMP-compliant production of adenoviral vectors at high titers and without the risk of RCA formation.

This whitepaper introduces the CAP®Ad platform, a production platform for Ad vectors based on CAP®cells and specifically designed to address these requirements. CAP® cells can be cultivated in all common bioreactors using serum-free, chemically defined media. They grow to high densities as single cells in suspension and support high titer, RCA-free adenoviral vector production. The paper provides further background information on the CAP®Ad production platform and typical process flows used for adenoviral vector manufacturing. With its excellent safety profile, scalability and productivity under serum-free culture conditions, the CAP®Ad technology is an outstanding platform for the industrial production of Ad vectors.



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