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The BioProcess International October Issue - Now Available in Print, Digital and Mobile App Editions
Date:10/31/2013

ver protein A. Lacki discuses the impact of those systems, pointing out their specific disadvantages that should be taken under consideration. In addition, he argues that the cost of protein A may be “misrepresented.” Finally, Lacki believes “smart engineering approaches” to the use of resins will be the next trend in efficient chomatography.

Best of BPI - Revisted: Virological Safety of Biopharmaceuticals

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.

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