Tangential flow filtration (TFF) is a unit operation that is used in monoclonal antibodies, recombinant proteins, and vaccine processing for ultrafiltration-diafiltration and/or clarification. In order to ensure the safety and efficacy of the drug, validation of the unit operations used in manufacturing is mandatory and a part of the regulatory requirement. The objective of validation of a unit operation is to demonstrate with a high degree of confidence that the process performs consistently. The present seminar will focus on the validation of the unit operation of TFF and will provide an overview of the regulatory landscape, the validation master plan, approaches to membrane re-use, cleaning validation, and best practices.
In this webinar, you will learn about:
- Validating TFF
- Validating a master plan
- Membrane reuse and cleaning
- TFF scale-down models
Speaker
Subhasis Banerjee, Ph.D.
Merck
Principal Bioprocessing Application Expert
Subhasis supports the technical consultation for downstream processing for the APAC region. He has a Ph.D. in biochemistry with post-doctoral experience from The Ohio State University, Columbus, USA. He has contributed to several publications in international peer-reviewed journals and conducted presentations in numerous national and international Conferences.
Pharma and biopharma manufacturing
- Liquid Formulation Strategies
기간:1h
언어:English
세션 1:발표 완료 July 13, 2021
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