Live eLearning ‐ PDA 459.2 Biopharmaceutical Manufacturing under Regulatory Compliance: Process Strategies, CGMP Considerations

Dr. Antonio R. Moreira is a well-known and highly regarded biotechnology expert in cell culture and fermentation bioprocessing. He holds a B.S. degree in chemical engineering from the University of Porto, Portugal and M.S. and Ph.D. degrees in chemical and biochemical engineering from the University of Pennsylvania. Dr. Moreira is President of Peritus Consultants, Inc., a consulting company that specializes in the bio/pharma industries. He is Professor of Chemical, Biochemical and Environmental Engineering at the University of Maryland, Baltimore County (UMBC) where he is Vice Provost for Academic Affairs since 1997. Dr. Moreira has also been Chair of the Department of Chemical and Biochemical Engineering and Associate Dean of Engineering at UMBC.

Prior to joining UMBC, Dr. Moreira spent ten years in the private sector, in senior technical management positions with International Flavors and Fragrances, Inc. and with Schering-Plough Corporation (now Merck & Co.). At Schering-Plough, he was responsible for the fermentation process development team that brought alpha-interferon to the market under FDA and many other international regulatory agencies approval. He was also responsible for the manufacture of biologics for the US market. He worked on additional biopharmaceutical products such as gamma interferon, GM-CSF, and IL-4. Dr. Moreira consults for a number of biotechnology companies in process development, regulatory and CGMP compliance, and validation of facilities and processes. He has an active research program currently focusing on the production of biologics via mammalian cell culture, including issues related to regulatory science. He has authored or co-authored over 200 scientific publications and presentations. He received the PDA James Agalloco award in 1997 and is an Associate Editor for the PDA Journal. Dr. Moreira was the Founding President of the Chesapeake Bay Area chapter of ISPE, he is a member of the International Board of Directors of ISPE and was Chair of the Council of Biotechnology Centers of the BIO Industry Organization. He has been a member of various FDA Advisory Committees. He is a graduate of Leadership Maryland.