Michael W. Glacken, Sc.D., Senior Consultant, of BioProcess Technology Consultants has over 24 years of experience in developing efficient manufacturing processes for biological products. His expertise spans all phase of biopharmaceutical process development including rapid protein supply to Discovery Science, development of cell culture and purification processes for all stages of the clinical life cycle, drafting and reviewing regulatory filings, process characterization and validation, technology transfer, CMO management, facility start-up and commercial launch preparation.
Prior to joining BioProcess Technology Consultants, Dr. Glacken was Vice President of Operations at Joule Unlimited, where he led a group of over 20 scientists, engineers and operators dedicated to the outdoor development of Joule’s proprietary large-scale photosynthetic bioreactors for the production of fuels from the sun.
In the 20 years prior to his position at Joule, Dr. Glacken was devoted to directing and managing the CMC development of biopharmaceuticals at several established companies, including Millennium Pharmaceuticals, Bristol-Myers Squibb and SmithKline Beecham. At Millennium, Dr. Glacken led the CMC team responsible developing manufacturing processes for and ensuring supply of vedolizumab (Entyvio) for clinical trials, and the Bioprocess Development Group which was responsible for the development and outsourcing of the drug substance process for all biologics in development.
Dr. Glacken received his B.S. in Chemical Engineering from the University of Maryland, his Sc.D. in Biochemical Engineering from the Massachusetts Institute of Technology and was an Assistant Professor in Chemical Engineering at Rice University. Dr. Glacken currently is associated with the National Center for Therapeutics Manufacturing at Texas A&M as a curriculum reviewer.