ARTICLES BY MARK F. WITCHER
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.