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Biography

Tathagata is Manager leading India Biomanufacuring Sciences Network Group, working for the last eight years in Merck Millipore. His expertise include optimizing downstream unit operations and providing scale up solutions to biological manufacturers. By academic qualification, Tathagata is Master’s in Biotechnology. Tathagatahas publications in national and international journals.

Abstract

Manufacturers of biologicals are required to demonstrate that their downstream processes are capable of clearing adventitious or endogenous viruses in order to insure against the incidence of viral contamination. Virus filtration is routinely used in downstream processing as a virus clearance step as it is considered robust, easy to use and entails relatively simple validation requirements. In this lecture, we examine the regulatory landscape as it applies to virus filtration of biologics as well as discuss the critical operating parameters that impact viral filter process implementation. The session will specifically cover current practices relating to virus filter validation, expected clearance requirements, typical performance for a robust filter operation, scale-up & operational considerations to ensure robust viral clearance assurance.

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