Webinar • BIO IT: BioPharma Asia Magazine

Viral Safety by Design for Cell and Gene Therapy ProductsAgéndalo en tu calendario habitual ¡en tu horario!

Domingo, 10 de noviembre de 2019, de 21.00 a 22.00 hs Horario de Virginia (US)
Webinar en inglés

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 constant risk to these biologics, and, as such they may impact directly product and patient safety. It is therefore of supreme importance to intentionally (by design) employ effective measures across the whole C> product manufacturing process to mitigate 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 the risk while providing a high degree of product safety by design.

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