The International Council for Harmonization (ICH) published its original Q5A guidance in 1997. This global regulatory guidance outlines expectations regarding viral safety and viral clearance approaches for biotech products derived from human or animal cell lines.

Since the original publication, new therapeutic and vaccine modalities such as cell therapies and viral vectors have been developed. State-of-the-art detection technologies have emerged, and new manufacturing paradigms such as continuous manufacturing are also being adopted.

All these present unique challenges, and the regulation is now catching up with scientific development and industry expectations. This guideline revision is critical to today’s biologics landscape and viral safety.

The draft revision includes guidance on applications of molecular methods such as High Throughput sequencing (HTS) (i.e. Next Generation Sequencing (NGS)) and degenerate PCR (such as the Blazar^® platform) for adventitious testing and viral clearance. It is confirmed that this will provide support for industry and regulators to assess the suitability of new methods in the context of viral safety.

ICH Q5A Scope

Impacts to Biosafety Testing

Impacts to Viral Clearance

The ICH Q5A revision addressing viral safety of biotechnology products derived from cell lines of human or animal origin was recently published for public comment.

A key strategy for viral risk mitigation is through the testing of the product at appropriate steps during the manufacturing process.

Requirements for viral clearance mostly remain the same. Flexibility can be offered for platform processes to leverage prior knowledge with appropriate justification.

Related Resources

Webinar: Viral safety of biologics: What's changing with the ICH Q5A revision?
Webinar: PDA Virus Conference Follow Up: What to Expect with ICHQ5A (R2) for mAbs, CGT, and Beyond
White Paper: Regulatory Considerations for Implementation of Alternative Microbial Methods for Quality Control Testing