Together with product efficacy, product safety is an essential characteristic of any medicinal product, including cell and gene therapy (C>) biologics. Adventitious agents (viruses, bacteria, mycoplasma, prions, etc.) pose a constant risk to these biologics, and, as such they may impact product and patient safety directly. It is therefore of supreme importance to intentionally (by design) employ effective measures across the whole C> product manufacturing process to mitigate the risk of adventitious agents. This presentation will review various interconnected steps throughout the manufacturing process, from the raw materials to the fill and finish, that would, in concert, help mitigate risk while providing a high degree of product safety by design.
Date/Time: 24 May 2019 | 15.00 pm GMT
Mark Plavsic, Chief Technology Officer at Lysogene
Dr. Archie Lovatt, Biosafety Scientific Director, SGS