The Road To Approval: Viral Clearance Strategies For Non-Enveloped Viral Vectors

The revised ICH Q5A(R2) guideline now includes viral vectors in its guidance for viral safety, emphasizing the expectation for a viral clearance study for non-enveloped viral vectors. Developing such a study involves the careful consideration of the risk of any adventitious, endogenous, or production viruses that could act as potential contaminants. It is essential to incorporate viral clearance steps into the manufacturing process that effectively inactivate and remove contaminants without negatively impacting the vector itself. A robust viral clearance study plays a key role in ensuring the overall viral safety of the vector on the road to regulatory approval. In this webinar, you will learn how to pinpoint potential sources of viral contaminants, establish manufacturing steps to remove or inactivate contaminants, make key distinctions between designing a viral clearance study for non-enveloped viral vectors versus those for monoclonal antibodies or recombinant proteins, and much more.