Manufacturers require approval from National Regulatory Authorities to therapeutically use cell and gene therapies, whether for clinical trials or as licensed products. However, prior to use, their freedom from potential adventitious agent contamination must be established.
Such rigorous, clearly defined testing requirements emerged to protect clinical trialists’ and ensure consumers’ safety. This is to prevent repetitions of historical contamination events. For example, when patients with hemophilia and blood-related conditions were infected with HIV and other blood-borne viruses in the 1970s after receiving treatment using proteins isolated from human plasma.
The adventitious agent tests required today detect contaminating adventitious agents in biopharmaceutical products throughout the pre-clinical, clinical and licensing stages of the product lifecycle. This webinar will outline current testing strategies for cell and gene therapeutics, focusing on the types of validated assay methods required to detect potential adventitious agents, in compliance with current global regulatory authority requirements.
This webinar will clarify key requirements and considerations for biosafety analysis of cell and gene therapeutics.
Target Audience: This webinar is aimed at development scientists, QC directors and managers, research and development directors and project managers working for life science companies (or other organizations seeking to develop cell and gene therapy products).
Cost: No Charge
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