ARTICLES BY MARK F. WITCHER
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![TS-153211616-1216]( "Are Good Manufacturing Practices No Longer Good Enough?")
Are Good Manufacturing Practices No Longer Good Enough?Janet 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?
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![filling_test_tubes_450x300]( "Developing And Manufacturing Cell & Gene Therapies: Do Biopharma Methods Apply?")
Developing And Manufacturing Cell & Gene Therapies: Do Biopharma Methods Apply?Are the methods used for developing the current generation of biopharmaceuticals, monoclonal antibodies, hormone replacements, etc., applicable to the next generation of Cellular and gene therapies?
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![risk-management-concept_iStock-629768058]( "Developing Optimal Pharmaceutical Quality Control Strategies")
Developing Optimal Pharmaceutical Quality Control StrategiesHow can pharma product quality improve? The first tactic could be to increase the frequency of vendor inspections, using internal quality control programs to inspect suppliers to assure compliance.
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).