What The ICH Q5A Virus Safety Guidelines Mean For Your Cell & Gene Therapy Product

Any Cell & Gene therapy (CGT) manufacturing strategy requires extensive characterization and release testing to assess the quality, safety, and efficacy of the intended final product. Many national regulatory agencies (i.e., FDA, EMA, NMPA, etc.) provide guidance on what type and degree of testing is expected; however, recommendations may not align between different national agencies. To address this, The International Council of Harmonization (ICH), a body of pharmaceutical regulatory experts, is tasked with harmonizing these quality and safety guidelines to benefit the global development of new pharmaceuticals while still maintaining safeguards to protect public health. The ICH’s quality chapter on viral safety testing for biological products (ICH Q5A) has recently been revised and now brings into scope a variety of CGT products. While the revision is still in draft, the final revision is expected in 2024 and has significant implications for the quality control and viral safety testing accepted and expected for viral-vector, viral-vector modified, or donor-derived CGT products.

Here, we provide a description of the CGT products now within the scope of the ICH Q5A guidance, descriptions of where alternative technologies can replace traditional testing strategies, the additional viral clearance studies some vector products are expected to complete, and how these changes will influence the viral safety testing strategies for future CGT products. Data and examples are presented to support the implication and changes expected from the ICH Q5A (R2) guidance.