Viral Clearance Studies – Current and Future Expectations
Live presentation and Q&A
Concept
Join Us!
The webinar will address past, current, and future viral clearance study designs. How options detailed in the revision 2 of the ICH Q5A can be implemented and acceptance by regulatory bodies across the world derived from experiences made by Charles River since the revision 2 implementation. It will be illustrated for classical CHO derived recombinants but also for more advanced products like Adeno-Associated-Viral Vector products.
- ICH Q5A(R2)
- Reduced study designs
- Regulatory acceptance
- Viral vector product types and others (e.g. vaccines)
- Platform approaches
- Prior knowledge
- New technologies (e.g. multi-spiking)
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Highlights
- Gain valuable insights and explore practical applications through scientific talks.
- Explore cutting-edge solutions at our product demonstrations and exhibition.
- Connect & engage with industry experts and peers to discuss innovative strategies for utilizing Sartorius' solutions.
Sessions
Agenda
Esteemed Voices From the Industry
Our selected experts will share insights on the latest trends, challenges, and developments in this dynamic field. Engage in unique discussions, learn about cutting-edge scientific discoveries, and explore the future of biopharmaceuticals with these influential thought leaders.
Dr. Horst Ruppach studied chemistry at the University of Cologne and the University of Marburg, Germany and earned his PhD in Virology (HIV) at the Georg Speyer House, Frankfurt. He has 25 years of experience in the field of virology. His scientific, technical, and regulatory expertise is in pathogen safety testing and virus/prion clearances studies for all kind of Biologics including Cell- and Gene Therapy products and medical devices. By expanding his expertise to all kind of analytical characterization and testing (identity, potency, purity….) required for Biologics from entering the clinical phase to commercialization he adopted the scientific leadership role at Charles River Biologics 2019. He supports and coordinates global analytical service developments and actively manages Charles River Biologic’s Testing portfolio.
