Borland tools4/6/2024 ![]() While there are no regulations solely dedicated to the viral safety of viral vector products, several guidance documents from various agencies provide relevant information on ensuring the viral safety of biological products. Both adventitious viral agents and replication-competent viruses are a concern, adds Tony Hitchcock, technical director with Cobra Biologics. Cell substrate banks, viral seed banks, raw materials of animal origin, bulk harvests, and the batches of the final manufactured clinical product all have to be tested, according to Francesca Vitelli, head of process development, for viral vectors at Lonza. Regulatory authorities require testing to be performed at every stage of the manufacturing process. Multiple analytical methods must be used, many of which have performance limitations, adding to the challenge. Because conventional viral clearance treatments would degrade or destroy many viral vectors, assessment of the potential risk for contamination and the implementation of prevention and control strategies are essential. Viral vectors must be free of viral contaminants, both adventitious agents introduced via raw materials and those generated during processing. ![]()
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