ARTICLES BY MARK F. WITCHER

• Revising Annex 1: A Case Study In Controlling Operating Risks By Understanding Uncertainty

  Unfortunately, the pharmaceutical industry does not understand how to control a risk’s likelihood of occurrence. The current draft of EU GMP Annex 1 is an example of the industry’s focus on a risk’s severity while not understanding or evaluating a risk’s uncertainty and thus defaulting to using the precautionary principle for guidance.

• Can We Eradicate Tech Transfer And Other 20th Century Pharma Manufacturing Practices?

  While warp-speed manufacturing is a pandemic term, the concept is important to the FDA’s 21st century vision of “a maximally efficient, agile, flexible pharmaceutical manufacturing sector that reliably produces high-quality drugs without extensive oversight.” Reaching 21st century performance requires replacing many 20th century practices.

• A Functional History Of Process Validation: Part 2 – The Key To A More Effective Future

  Part 1 of this two-part series discussed the history and underlying concepts of process validation (PV), which is required for dealing with the increasingly sophisticated pharmaceutical manufacturing processes necessary for realizing advanced medical therapies. This article describes how PV concepts can be evolved so the industry can better develop, manufacture, and launch the next generations of biopharmaceutical products.

• A Functional History Of Process Validation, Part 1 – A Weak Foundation

  This article is the first of a two-part series that describes the origins of process validation to explain the underlying concepts necessary to control the advanced bioprocess manufacturing technologies required to make the next generations of biopharmaceutical therapies.

• System Risk Structures: A New Framework For Avoiding Disaster By Managing Risks

  Risks are ubiquitous, occurring in every aspect of our personal and professional lives. This article describes how pharmaceutical development and manufacturing risks can be easily understood and effectively managed using straightforward concepts.

• What Managing Personal SARS-CoV-2 Risks Can Teach Us About Managing Pharma Risks

  This article describes how the basic principles of managing personal risks of being infected by a respiratory virus can be used to manage risks for developing and manufacturing pharmaceuticals. The goal is to elucidate the basic principles of understanding, managing, and communicating a wide variety of risks from the trivially simple to the very complex.

• 2 (Major) Impediments To Faster Biopharmaceutical Product Development

  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.

• Can Biosimilars Be The Bridge To More Widespread Continuous Bioprocessing?

  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.

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

  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.

• A Straightforward, Risk-Based Approach to Better Quality Management System Design

  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. 

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

  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.

• 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?

• 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?

• Developing Optimal Pharmaceutical Quality Control Strategies

  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.