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Jia-Hwa Fang, Ph.D., leads a team in scale up and clinical manufacturing of early-stage clinical trial materials (CTM) in compliance with current Good Manufacturing Practices (cGMP).
Fang has a broad range of expertise in process development and manufacture of small molecules and biologics for drug products such as parenterals, tablets, capsules, transdermals, suspensions, and topicals. He has extensive experience in all phases of clinical manufacturing, including process troubleshooting, and validation. He has also worked in technology and manufacturing process transfer for late-stage products.
Fang has more than 20 years of industry experience at small and large biotech companies. Prior to joining SRI, Fang was a consultant for Impax Laboratories, Inc. Previously, he was director of formulation and manufacturing at CMC Technology Management Group, and was responsible for formulation and manufacturing at APT Pharmaceuticals. Earlier, he was a senior scientist at Novartis, Chiron Corporation, and TheraTech Inc. He has successfully developed and manufactured microparticles under aseptic conditions for clinical trials, a proprietary adjuvant manufacturing process for Fluad® vaccine, and transdermal formulation for Theraderm®.
He has authored and reviewed regulatory documentation and submissions such as manufacturing and validation protocols and chemistry, manufacturing, and controls (CMC) sections for investigational new drug (IND) and new drug application (NDA) filings in the U.S. and European Medicines Agency (EMA) filings in Europe.
Fang’s Ph.D. in chemistry is from the Missouri University of Science and Technology. He completed a postdoctoral fellowship at Clarkson University, where he developed and transferred a process for the manufacturing of perfluorohydrocarbon blood substitute emulsions.
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