Paradigm for Process Validation of Biopharmaceuticals
Posted on September 2, 2015
By: Kim H. Wong, Ph.D.
Director, Facilities & cGMP Support, BioProcess Research & Development
Sanofi Pasteur Ltd
Introduction Paradigm: a theory or a group of ideas about how something should be done, made, or thought about. (reference: Merriam-Webster dictionary) During the past 12 years there has been a gradual but significant paradigm shift regarding the strategy of how pharmaceuticals should be developed a...
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Related Topics and Keywords
biological entities, EMA, enhance the quality, General Principles and Practices” in 2011, ICH, integrated quality system, Kim H. Wong, lifecycle approach, NBEs, NCEs, new chemical, new science-based principles, on-going knowledge management, Process Validation of Biopharmaceuticals, product and process knowledge, quality risk management, Sanofi Pasteur Ltd., technological innovation, the FDA
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