This online training session will cover a case study of the selection, installation and operation of a flexible design and production platform that allows for clinical vaccine production. This unique cGMP mobile adaptive biopharma production platform was placed into operation in New Haven, CT in April 2016. Installation occurred in a matter of days and has been certified and operational since early May 2016. This true, Facility of the Future solution enabled critical preclinical stage vaccine development and clinical trial manufacturing to occur in house, with ACT's technology and expertise. Dr. Donald S. Masters will discuss the rationale for selecting their adaptive facility solution and the operation of this innovative facility. You will gain insight into how one company defined their facility needs, developed flexible design and production platform selection criteria and worked to implement an innovative approach to meet their critical R&D enablement needs.
Jeff Serle is the Senior Vice President of Germfree Laboratories, Incorporated in Ormond Beach, Florida. During his 25 year career at Germfree he has lead the design of Biological Safety Cabinets, Laminar Flow Equipment, Pharmacy Isolators, Class III Gloveboxes, as well as Modular and Mobile BSL 3 Laboratories and Cleanrooms. Jeff holds a Bachelor of Science in Mechanical Engineering from Florida International University. Jeff has been a long standing Member of the Controlled Environment Testing Association (CETA) and has twice been selected to serve on the Board of Directors in 1997, then again in 2009. Jeff served CETA as the Chair of the CETA National Board of Testing (CNBT), which developed the Registered Cleanroom Certification Professional for Sterile Compounding (RCCP-SC) Exam, from 2009 - 2012 and is formerly the President of CETA. Jeff is also a member of the American Biological Safety Association and the American Society of Heating, refrigeration, and Air-conditioning Engineers.
Dr. Donald Masters is President and Chief Executive officer of Artificial Cell Technologies. His twenty-nine year career began as a member of the Harvard-Monsanto Project that led to the development of the Biotechnology industry. He left Harvard to become the fifth employee at Genzyme, creating their successful Research Biologicals business unit which was eventually sold for $67 million. He left Genzyme to become the founding CEO of OxiGene, which is now a public company. Following his tenure at OxiGene he became involved in the information technology field, heading up the Biological Applications Program at TASC, INC., a $300 million per year information technology company, and TechEx a B2B exchange connecting University technology transfer offices to pharmaceutical companies which he successfully sold in 2002. After a period as a Principal at Commonwealth Pharmaceutical Partners, a business development consultancy and affiliate of the Medical Science Partners venture capital fund, he returned to the Biotech CEO ranks, heading up three start-ups: Bion, Inc, C3 Scientific Corporation and Esperance Pharmaceutical. Dr. Masters became CEO of ACT in July of 2008.Dr. Masters graduated from Johns Hopkins University with a degree in Biophysics, Received his Ph.D. in Biochemistry and Immunology from Cornell University Medical College and was a Post-doctoral Fellow at Harvard Medical School.