ICH Q5A(R2)

Since the publication of the Q5A(R1) Guideline in 1999, there has been advances in biotechnology product development and manufacturing that are not reflected in the original guideline. Additionally, emergence of new virus detection technologies and evolvement of strategies for virus clearance strategies based on manufacturing experience and scientific consensus has occurred. The revision of ICH Q5A(R2) was endorsed as a new topic for ICH harmonization in June 2019 and the concept paper was published in Nov 2019. The following areas were proposed for updating the ICH Q5A(R1):

• New classes of biotechnology products (e.g., virus-like particles (VLPs), subunit proteins, and viral-vectored products)
• Additional validation approaches for virus clearance (e.g., modular validation)
• New virus assays and alternative analytical methods (e.g., PCR, NGS)
• Virus clearance validation and risk mitigation strategies for advanced manufacturing (e.g., continuous manufacturing)
• Aspects of virus clearance validation that have emerged or evolved

This session will include brief presentations to describe the context for revisions to the guideline, and then provide opportunity for discussions related to their incorporation. For example:
1. How will the updates support or impact your current manufacturing process and practices?
2. Do you think the updates will address current gaps? Do you have additional suggestions within the scope of the updates?
3. What are the most challenging topics within viral safety validation for continuous / advanced manufacturing?