Viral safety of cell therapies webinar

Join members of BioPhorm Advanced Therapy Medicinal Products as they explore viral safety in cell therapy products, including regulatory landscapes, risk factors and practical mitigation strategies. This session highlights insights from a recent publication and provides a structured approach to viral contamination risk assessment using CAR-T as an example. What you'll learn: Why viral safety is critical for cell and gene therapies Key regulatory guidelines from FDA, EMA, USP and EP Risk factors across the cell therapy manufacturing process How to apply a viral contamination risk evaluation matrix Best practices for prevention and testing Download the full publication: https://eu1.hubs.ly/H0pWT3-0 Chapters 0:00 – Webinar and BioPhorum introduction 4:27 – Background on the publication 7:36 – Why viral safety matters for cell therapies 8:24 – Regulatory landscape overview 13:17 – Guidance on raw and starting materials 16:45 – Testing strategies and mitigation tools 17:36 – Risk factors in cell therapy processes 18:22 – CAR-T manufacturing as a model 21:01 – Viral safety risk matrix explained 22:02 – Patient and donor risk assessment 24:23 – Raw and ancillary materials risk 28:43 – Operator risk 30:01 – Starting materials and vectors 32:07 – Environment and facility risks 33:05 – Storage and transportation risks 34:18 – Summary of risk matrix 35:06 – Three pillars of viral safety 36:22 – Key takeaways and conclusion