Shaping the Future of Viral Clearance: Analyzing ICH Q5A(R2) and Its Impacts

In October 2022, a new draft of ICH Q5A (R2) was released, the first such update in more than 20 years. This draft revision was necessary to reflect current scientific knowledge and biotechnology advances such as new product types that are amenable to viral clearance and alternative virus clearance validation strategies.

In this report, we delve into the evolving landscape of viral clearance practices, focusing on the implementation of continuous manufacturing, advancements in study design, and the implications for cell and gene therapy products.  Additional topics discussed include the vital role of detergent treatment, low pH treatment, and viral filtration in shaping the future of viral clearance.

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