ARTICLES BY MARK F. WITCHER

• FMEA Vs. System Risk Structures (SRS): Which Is More Useful?

  9/24/2021

  In 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?

• Why Controlling CQAs Isn’t Good Enough For Gene & Cell Therapies

  3/31/2020

  It'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.

• 3 Keys To Realizing FDA’s Vision For CAR-T And Other ATMPs

  12/12/2019

  While 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.

• Developing And Manufacturing Cell & Gene Therapies: Do Biopharma Methods Apply?

  9/3/2019

  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?