David Vetterlein, PhDAdjunct Professor/Faculty Advisor, Team Master's Project
Upstream and Downstream Biologics Process Development and Troubleshooting, GMP Manufacturing (pre-IND through commercial), Protein Characterization and Analysis, New Technology Assessments, Facilities Layout, Design and Evaluation, Biologics CMO Arrangements and Management, Biologics Process Transfer and Implementation, Project Management, CMC Regulatory Submission Preparation and Review
David Vetterlein, PhD, has over 30 years of biotechnology experience in the areas of bioprocessing and protein manufacturing. Most recently, Dr. Vetterlein worked in numerous capacities at ICOS Corporation. At ICOS, he built a clinical manufacturing facility and developed the infrastructure needed to support a pipeline of biologic products at a production scale of up to 3,000L. This included hiring and staff management for process engineering, project management, upstream and downstream process development and cGMP manufacturing through Phase III development in preparation for commercial launch. Additionally, Dr. Vetterlein established a very successful contract manufacturing business at ICOS, completing more than 25 different projects from yeast, CHO and E.coli origin and developing many novel biologic manufacturing processes and characterization methods. In 2007, the ICOS biologics division was sold to CMC Biopharma of Copenhagen and Dr. Vetterlein became Chief Science Officer, focusing on process troubleshooting, originating new process technologies, and establishing the conceptual design for a large-scale commercial manufacturing facility.
Prior to ICOS, Dr. Vetterlein worked at Genentech, Inc. for 10 years as a Senior Scientist where he developed processes for manufacturing of vaccines, antibodies and other proteins. He is a member of the Amgen Bioprocess Advisory Board at Keck Graduate Institute of Applied Life Sciences in Claremont, CA and in 2009 he became an adjunct faculty member. Dr. Vetterlein earned in PhD in Biology (Biochemistry) from the University of California at Santa Barbara, where he utilized biophysical methods to study the kinetic and allosteric properties of a cytoplasmic enzyme. Dr. Vetterlein has been consulting in the area of Biologics Process Development, CMO Arrangements and GMP Manufacturing since November 2008.
|David Vetterlein, PhD|