ARTICLES BY MARK F. WITCHER
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![EDITED-iStock-1320989364]( "FMEA Vs. System Risk Structures (SRS): Which Is More Useful?")
FMEA Vs. System Risk Structures (SRS): Which Is More Useful?9/24/2021In this article, Mark Witcher, Ph.D., discusses the many failure modes of FMEA and risk priority number (RPN), comparing and contrasting it with system risk structures (SRS) and adjusted risk likelihood (RPN). He concludes that one of these is more useful than the other for pharma and medical devices; which one is it?
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![Bridge Over Water]( "Can Biosimilars Be The Bridge To More Widespread Continuous Bioprocessing?")
Can Biosimilars Be The Bridge To More Widespread Continuous Bioprocessing?5/19/2020This article will examine the relationship between improved continuous manufacturing (CM) and biosimilar development, paying particular attention to the reasons why biosimilars are especially promising candidates for CM development and innovation.
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![TS-153211616-1216]( "Are Good Manufacturing Practices No Longer Good Enough?")
Are Good Manufacturing Practices No Longer Good Enough?10/28/2019Janet Woodcock’s recent comment on the state of pharmaceutical development,“It’s not working…,” should not surprise anyone. Her continuation, “and, it won’t work in the future," is the more surprising, and particularly troubling statement. What must we change?
Mark F. Witcher
Mark F. Witcher, Ph.D., has over 35 years of experience in biopharmaceuticals. He currently consults with a few select companies. Previously, he worked for several engineering companies on feasibility and conceptual design studies for advanced biopharmaceutical manufacturing facilities. Witcher was an independent consultant in the biopharmaceutical industry for 15 years on operational issues related to: product and process development, strategic business development, clinical and commercial manufacturing, tech transfer, and facility design. He also taught courses on process validation for ISPE. He was previously the SVP of manufacturing operations for Covance Biotechnology Services, where he was responsible for the design, construction, start-up, and operation of their $50-million contract manufacturing facility. Prior to joining Covance, Witcher was VP of manufacturing at Amgen. You can reach him at witchermf@aol.com or on LinkedIn (linkedin.com/in/mark-witcher).