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# ICH Guide on Cell-line Product Viral Safety
- URL: https://www.fdaweb.com/ich-guide-on-cell-line-product-viral-safety/
- Published: 2022-11-10T12:00:00.000Z
- Updated: 2026-09-14T18:06:04.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5153173

FDA is seeking comments on a [draft guidance](https://www.fda.gov/media/163115/download?ref=fdaweb.com) entitled “Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin Q5A(R2).” The International Council for Harmonization document addresses the testing and evaluation of the viral safety of biotechnology products, and it outlines what data should be submitted in marketing applications. It covers products produced from *in vitro* cell culture using recombinant DNA technologies such as interferons, monoclonal antibodies, and recombinant subunit vaccines. The guidance also applies to certain genetically-engineered viral vectors and viral vector-derived products.