Dr. Blank is a a recognized global leader in bioprocess development with over 23 years at Genentech, most recently as Director of the Late Stage Purification Department responsible for development of commercial processes, post approval changes, and process validation. Also reporting to Dr. Blank was the virus validation group. He received his Ph.D. in cell biology from the University of Southern California in 1981. Following post-doctoral fellowships at Case Western University School of Medicine and Becton Dickinson Monoclonal Center he joined the Recovery Sciences Department at Genentech in 1987, becoming department director in 2000. While at Genentech, Dr. Blank has focused on monoclonal antibody process technology and has led the development and commercial scale-up of recovery processes for both full-length antibodies (including Rituxan, Herceptin, and Raptiva) from mammalian cells and antibody fragments from bacteria. The purification processes Dr. Blank developed for Herceptin and Rituxan have formed the purification platform for all of Genentech’s monoclonal antibodies. He has also helped develop Genentech’s approach to process validation including virus validation, modular validation, and Quality by Design.Since 2010 Dr. Blank has consulted organizations across the globe in the areas of purification process development, scale-up of manufacturing operations, process validation and characterization, virus validation, and regulatory filings.
He has over 40 publications and patents in areas of process development, process validation, manufacturing operations, virus validation, documentation and has lectured extensively in these areas. He has had an appointment as an Adjunct Professor in the Department of Pharmaceutical Chemistry, University of Kansas and is on the Editorial Board of BioProcessing Journal.
Matthew S. Croughan
Since 1988, Matt has worked as an independent consultant providing expert guidance on biopharmaceutical, cell therapy, and biofuels process development and manufacturing to more than 65 firms. He serves on the Scientific Advisory Board or External Advisory Panel for several firms, ranging Pfizer to Pfenex to PBS Biotech, and also frequently works as an expert witness for court cases. From June 2013 to August 2014, he was Chief Technology Officer at Sapphire Energy, Inc., where he led the R & D effort, with a staff of up to 90 scientist and engineers, to invent, develop, and commercialize methods to economically produce renewable crude oil from algae. From January 2006 to August 2013, Matt was the George B. and Joy Rathmann Professor and Director of the Amgen Bioprocessing Center at Keck Graduate Institute (KGI) in Claremont, CA. Recruited by Dennis Fenton, KGI Board member and EVP Amgen, Matt was the founding professor of the KGI bioprocessing program, with over 108 masters and two doctoral graduates as his advisees. Prior to 1998, he worked at Genentech for 10 years, in process development and manufacturing sciences, where he developed the first licensed, high density, fed batch animal cell culture process, a core technology now used for dozens of commercial products with ~$100 billion in total annual sales. Matt has two chemical engineering degrees, a Ph.D. from MIT (1988) and BS from UC Berkeley (1983).
Dennis Fenton, PhD, an industry pioneer, has over three decades of experience in biotechnology. Dr. Fenton retired after a lengthy and distinguished career with Amgen, where he held a variety of notable roles, including Executive Vice President, Operations. Prior to Amgen, he was a senior researcher with Pfizer. Dr. Fenton most recently served on the board of directors of Hospira, Dendreon Corporation, Genzyme, Kythera Biopharmaceuticals, XenoPort, Nora Therapeutics and Amira Pharmaceuticals. He is an alumnus of Rutgers University, where he graduated with a Ph.D. in microbiology. Dr. Fenton currently serves as a member of the board of directors for Portola Pharmaceuticals, Sienna, and Modern Meadows.