This chapter is taken from the book Pharmaceutical Outsourcing: Quality Management and Project Delivery
These experts offer an excellent description of contract manufacturing and control to those involved in early phase production including cGMP, quality systems and the pathway for Phase I, II, III and the BLA.
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About the Authors
John Conner, currently Vice President of Manufacturing Science and Technology at Cytovance, has over 30 years of experience in research, process development and manufacturing of complex biotherapeutics. Before joining Cytovance, John directed Manufacturing Technical Support, Manufacturing and Process/Analytical Method development at CancerVax where he characterized, developed and managed process development, scaleup and manufacturing of many different complex cancer immunotherapeutics. John was also involved in the design and build out of several GMP manufacturing facilities at CancerVax. John attended Texas Tech University and holds a B.S. in Microbiology and completed his M.S. Graduate Studies in Biological Sciences from the University of Texas at El Paso.
Rabi Prusti, Ph.D., currently Executive Director of Quality Control and Analytical Development at Cytovance, has over 20 years of experience in R&D, Quality Systems, Quality Control and Compliance, Assay Development, Validation, CMC Documentation including IND, NDA and DMF. As a biochemist he has product development experience in new product and commercial platforms with human growth factors, virus free plasma proteins, bacterial proteins (enzymes), cell based immunotherapy product, and monoclonal antibody. He has written and contributed to numerous published papers and abstracts. Rabi completed his Bachelor of Science at Utkal University in India, Master of Science and Master of Philosophy at Nehru University, New Delhi, India. He holds a Ph.D. in Biochemistry from Texas Tech University and completed his post-doctoral research at the University of Washington, School of Medicine in Seattle.
Bill Minshall, currently Senior Vice President of Regulatory Affairs at Cytovance, has more than 30 years of experience in the Pharmaceutical/Biotech industry. Prior to joining Cytovance, Bill
was Principal of ASL Consultants, Inc., a consulting group that focused primarily on FDA regulated industries. Bill holds a Bachelor of Science in Mechanical Engineering from the United States Air Force Academy and a Master of Science in Operations Management from the University of Arkansas.