San Francisco, California
London, United Kingdom
Presented by EG Life Sciences
We will be meeting at the MassBio in Cambridge, MA on the 8th Floor. Food and drinks will be provided.We look forward to seeing you there!
Topic: Core Components for Contamination Prevention and Control in Biopharmaceutical Manufacturing Operations
A 2016 review of FDA’s MedWatch Safety Alert Archive for Drugs and Therapeutic Biological Products revealed that 25% (15 of 60) of safety alerts involved microbial contamination or lack of sterility assurance. Moreover, according to a survey conducted by BioPlan in 2016 between 2 and 2 1/2% of biopharmaceutical production in process batches are lost to contamination. Contamination control constitutes a never ending concern for biopharmaceutical manufacturing operations requiring extraordinary attention to detail by a multidisciplinary group of dedicated individuals. Drawing upon 26 years’ experience in cell therapy and biological product manufacturing the core components for contamination prevention and control are the focus of this presentation.
Through an understanding of the multifactorial origins, dynamics of microbial contamination within the manufacturing environment, mode of transfer and mechanisms of amplification application of robust countermeasures directed at protecting the batch can be deployed. Creation of a proactive environmental action committee drawn from a number of manufacturing site-based operations disciplines can be an essential element of control to facilitate, investigate, interdict and prevent contamination events. Contamination control must be an inclusive and highly visible activity supported by senior management with an ability to promptly deploy countermeasures when adverse trends warrant such action.
ABOUT OUR GUEST SPEAKER:
Gary C. du Moulin, Ph.D., M.P.H. retired as Senior Director of Quality Aseptic Control for Genzyme (A Sanofi Company) where he participated in the development and execution of robust quality systems for Genzyme’s products including biologics and cell based therapies. Dr. du Moulin joined Genzyme Biosurgery in 1995 as Vice President, Quality Operations after working for six years developing quality systems for cellular therapies for the treatment of renal cell carcinoma. Prior to his industrial experience, he spent 15 years on the faculty of Harvard Medical School in the Department of Anesthesia at Beth Israel Hospital. He has more than 150 publications in the areas of microbiology, epidemiology, and the regulation and quality control of living cells as a therapeutic modality. Dr. du Moulin received his B.S. in 1969 from Norwich University, an M.S. degree from Northeastern University, and M.P.H. and Ph. D. degrees from Boston University. Dr. du Moulin has served on U.S. Pharmacopoeia’s General Chapters Biological Analysis Expert Committee, the Gene Therapy, Cell Therapy, and Tissue Engineering Expert Committee, and Modern Microbiological Methods Expert Panel. He chaired the ad hoc advisory panel for fetal bovine serum. He serves on the editorial board of Regenerative Medicine and is RAC certified and past Chairman of the Editorial Board of the Regulatory Affairs Professionals Society Magazine, Regulatory Focus and was appointed to the Grants Review Working Group of the California Institute for Regenerative Medicine. He is retired from the U.S. Army Reserve at the rank of Colonel after 38 years of service and currently teaches at the Massachusetts College of Pharmacy and Health Sciences University in Boston as Adjunct Associate Professor of Drug Regulatory Affairs.
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EG Life Sciences
EG Life Sciences is a professional consulting services firm that delivers flexible, scalable solutions for Pharmaceutical, Biotechnology, and Medical Device companies, including the resources they need to meet the unique challenges of FDA regulations.