Articles by Mark F. Witcher

  1. 2 (Major) Impediments To Faster Biopharma Product Development 5/29/2020

    As pharma products have become more complicated, companies have become bogged down in accomplishing their mission of launching new products because of complex regulatory requirements, convoluted management approaches, and inefficient resources and methods that add time and cost to moving new products from research to patients.

  2. Can Biosimilars Be The Bridge To More Widespread Continuous Bioprocessing? 5/19/2020

    This 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.

  3. 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.

  4. Straightforward, Risk-Based Approach To Better Quality Management Design 3/18/2020

    As biopharma products and processes gain complexity, so does the design and implementation of the QMS' necessary to support development and manufacturing. This article describes an approach for building a QMS based on the identification of risk exposed to the product, manufacturing process, employees, and patients during development and manufacturing. 

  5. 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.

  6. Are Good Manufacturing Practices No Longer Good Enough? 10/28/2019

    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?

  7. 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?

  8. How To Develop Optimal Pharmaceutical Quality Control Strategies 6/14/2019

    How 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.