MilliporeSigma

ICH Q5A(R2) Regulatory Guidance Update

Understand the full impact to biosafety testing


The International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (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 modalities have been developed and this new publication now covers  monoclonal antibodies, recombinant proteins and viral vectors. 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 update includes guidance on application of molecular based methods such as Next Generation Sequencing ( NGS) and PCR for adventitious agent detection.  The use of NGS to replace in vivo extraneous agent detection is encouraged.  The classical MAP/HAP/RAP assay can be replaced using nucleic amplification techniques such as PCR or NGS systems. Where applicable, NGS and PCR may be appropriate to address broad and specific virus detection in starting and harvest materials.

Our regulatory experts have evaluated the changes to the ICH Q5A(R2) guidance and are hosting webinars as well as presentations helping biopharma companies understand the opportunities and challenges the revised guideline presents in the implementation of novel approaches.


ICH Q5A(R2): What’s new and changing? 

ICH Q5A (R2) Scope 

Impacts to Biosafety Testing

Impacts to Viral Clearance

The ICH Q5A (R2) revision addressing viral safety of biotechnology products derived from cell lines of human or animal origin was recently published.

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. 


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