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Steve Kuwahara

Steven S. Kuwahara, Ph.D. is the West Coast Representative of BioInsights, Inc.. Dr. Kuwahara holds degrees in biochemistry from Cornell University (B.S.) and from the University of Wisconsin-Madison (M.S. and Ph.D.). After post-doctoral studies at the University of Washington, he spent four years on the chemistry faculty of the California State University at Long Beach, and two years as an NIH Special Research Fellow with the Department of Organismic Biology of the University of California at Irvine. He has worked with biologics for over 25 years, specializing in assay development, QA, and QC. He has worked in the Biologic Products Division of the Michigan Department of Public Healthth (now BioPort Corp.),the Hyland Division of Baxter Healthcare (now Baxter Biotech), Pyramid Laboratories, Alpha Therapeutics, SyStemics, BioReliance and Titan Pharmaceuticals. He has dealt with the testing and GMP requirements for manufacturing vaccines, blood derivatives, cellular and gene therapeutics, and small molecule drugs. He serves on the editorial boards of BioPharm, BioQuality and the Journal of GXP Compliance. In recent years Dr. Kuwahara has presented a large number of talks and authored several articles covering GMP and testing requirements for biopharmaceuticals. He has instructed short courses in training programs run by the PDA, Pharmaceutical training Institute, and IBC. He continues to teach the introductory GMP of Biopharmaceuticals course in the University of California at Santa Cruz extension program for Biotechnology.