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DENIS BOYLE, PH.D.

Consultant

Dr. Denis Boyle is an internationally recognized bioprocess expert with more than 25 years of experience in the development and validation of technologies to produce biopharmaceuticals. He has led numerous protein therapeutic development teams for Pfizer spanning nearly 20 years, and includes several validated GMP animal health vaccines and the first monoclonal antibody for companion animals.  He was responsible for all bulk protein production for Promega Corp. of over 200 products including GMP enzymes that form Class I Medical Device products.

His expertise includes leading upstream microbial and mammalian production technology teams using stainless steel and single use bioreactors and personally directed the successful tech transfer and scale up to pilot and GMP commercial scale of over 12 protein products.  These products ranged from engineered growth factors or fusion proteins in E. coli requiring refolding, PEGylation or other chemistries, to high solids fermentations of secreted proteins in yeast and to monoclonal antibodies from CHO cells.  He also designed and completed process characterization studies and successful process validations for product registration and commercialization.

Denis has been an invited speaker and an extensively published author and referee and has received awards for his publications. He has detailed knowledge of the CMC milestones on the path to Regulatory approval, including alignment with clinical studies outcomes.

He holds a Ph.D. from University of the Witwatersrand, Johannesburg, S. Africa in Medical Biochemistry.