ARTICLES BY MARK F. WITCHER
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![Dart in Dartboard]( "Why Controlling CQAs Isn’t Good Enough For Gene & Cell Therapies")
Why Controlling CQAs Isn’t Good Enough For Gene & Cell TherapiesIt's frequently stated in the biopharma industry that to control a product’s critical quality attributes (CQAs) one must control the process’ critical process parameters (CPPs). While the statement is accurate literally, it does not convey the true technical requirements for controlling product quality.
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![iStock-1022130186]( "3 Keys To Realizing FDA’s Vision For CAR-T And Other ATMPs")
3 Keys To Realizing FDA’s Vision For CAR-T And Other ATMPsWhile cell therapy remains a very promising approach to developing much-needed new immunotherapies, significant challenges will have to be overcome in order to realize the FDA’s twenty-first century vision of making complex ATMPs widely and cost effectively available to patients.
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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?
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).