Module 9 2021

19/03/2021

ICH Q5A The 3-pronged Approach to virus safety of Biopharmaceuticals (a holistic approach)

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Cell Banks Bulk Harvest IVCA testing

Virus Safety

Virus Clearance Validation

Process Intermediates

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Components of viruses

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• CHO cells are host to mammalian viruses • E.coli are host to bacteriophage • Yeast are host to retroviral like elements and others including L-A virus • Nucleic acid genome (RNA or DNA) • Protein to give a nucleocapsid • Which may or may not have a lipid envelope • And/or associated with other proteins • Have no biochemical machinery (except sometimes for certain enzymes) • Cannot grow by themselves and require a cell to propagate • Inactivated by chemicals and heat

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