Virological Safety of Biopharmaceuticals October 2013

In an audiocast with managing editor Maribel Rios, Hazel Aranha (manager of viral clearance and safety at Catalent Pharma Solutions) discusses risk assessment and management strategies since her November 2005 article, “Virological Safety of Biopharmaceuticals.” Several factors have made risk an increasingly important issue, including the globalization of the industry and concerns over emerging viruses. Some strategies for addressing risk — such as the “as low as is reasonably practicable” (ALARP) approach and conducting a cost–benefit and decision analysis — are still appropriate. ICH has developed risk-related documents, including Q9, Q10, and Q11. Aranha discusses the effects of those guidelines on risk mitigation. She also talks about how increased collaboration between industry and regulatory groups and between industry and suppliers will be a major part of the bioprocessing industry in the next five years.