Scott Lute, MSc Food and Drug Administration

Scott Lute is a Senior Biologist and Product Quality Assessor in the Office of Biotechnology Products, Division 2 and a member of the CDER Manufacturing Science & Innovation Center of Excellence. He has been with CDER/OBP since 2002. Over the past 20 years he has extensively studied various aspects of monoclonal antibody manufacturing focusing on regulatory concerns associated with the viral safety of downstream bioprocessing. His research has supported the development of PDA Technical Reports and the establishment of recent “Recommended Practices” for OBP, providing a knowledge base for FDA assessors. His current research focus includes advanced manufacturing technologies with a focus on continuous manufacturing to provide regulatory support for the Emerging Technology Program submissions at CDER.