Launching New Biologics: A Process and Facility Design Approach
Process and facility design approaches can be delineated by three distinct stages of a new productís lifecycle: product development, launch, and commercial manufacturing. In the product development stage, the conflicting desires to manage risk and to assure rapid time to market are balanced against developing well understood processes. To maximize speed to market while minimizing spending, launch planning is focused on rapid execution to accelerate technology transfer and capacity expansion. As products move into commercial manufacturing, meeting strict production requirements in a consistent and reliable fashion and at the lowest possible cost become the key drivers. Approaches are discussed which address the shifting business drivers within a productís lifecycle and lay a framework for an integrated approach to process and facility design.
Note: This chapter was originally published in the first edition of this study, in its entirety.
About the Authors
Trent Carrier, Ph.D., Associate Director, Merck & Co., Inc. (Affiliation at time of first edition)
Dr. Carrier, an Associate Director in Vaccine Process Engineering, is focused primarily on the use of standardization and project execution strategies as a means to improve capital effectiveness, technology transfer, and manufacturing operations. Dr. Carrierís experience in biopharmaceuticals includes process and facility design for monoclonal antibodies, Adenovirus vectors, and bacterial vaccines. Dr. Carrier received a B.Ch.E. from North Carolina State University and a Ph.D. in Chemical Engineering from University of California, Berkeley.
Marshall Gayton, Director, Merck & Co., Inc.
Mr. Gayton is a Director in Bioprocess Research and Development, where he is currently responsible for operations of a multiproduct biopharmaceutical pilot plant and the preparation bulk clinical supplies for vaccines and therapeutic proteins. Mr. Gaytonís experience in APIs and biopharmaceutical spans over 15 years including manufacturing technical support, purification process development, and technology transfer to manufacturing for natural products and vaccines. Mr. Gayton received a B.S. degree in Chemical Engineering from Rutgers University and a M.S. in Chemical Engineering from Rice University.
Joye L. Bramble, Ph.D., Executive Director, Merck & Co., Inc.
Dr. Bramble is an Executive Director in Bioprocess Research and Development, where she is primarily responsible for biological clinical supply manufacture and release, associated GMP automation systems, and the development of supportive business systems and processes. Dr. Brambleís experience in biopharmaceuticals spans over 13 years including manufacturing, development, and equipment and facility design for cell culture based biological products. Dr. Bramble received a B.Ch.E. from University of Delaware and a Ph.D. from University of Pennsylvania in Chemical/Biochemical Engineering.
Abraham Shamir, Ph.D., Senior Director, Merck & Co., Inc.
Dr. Abraham Shamir is a Senior Director of Vaccine Process Engineering in the Manufacturing Division. Dr. Shamir has been with Merck since 1989 and held different positions of responsibility for vaccine technical operations and process engineering including direct manufacturing support, technology transfer for new vaccine entities and process design, qualification and start-up. Dr. Shamir received a B.S. degree in Biochemistry and a Ph.D. in Chemical Engineering from Columbia University.