CRL Viral Clearance Studies – Current and Future Expectations

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)