Denis M. Boyle, BA, MS, PhD
CMC BioPharma Consulting, LLC
Hampstead, North Carolina
Intellectual Property Expert Witness, Biomedical Engineering Expert Witness
Patent Infringement, Biopharmaceuticals, Bioprocess Technology, Biologics Manufacturing, Recombinant Proteins, Biochemistry, Engineering-Chemical, Engineering-Biomedical, GMO, Genetics, Microbiology, Natural Products Chemistry, Biomedical Research
Dr. Denis Boyle is an internationally recognized bioprocess expert with more than 25 years of experience in the development, validation and patent protection of technologies to produce biopharmaceuticals for commercial launch.
He has led protein therapeutic development teams for nearly 20 years, including GMP animal health vaccines. He led both microbial and mammalian upstream production technology development teams, recognized as a downstream bioprocess and chromatography expert, and was responsible for the transfer and scale up of commercial GMP production of multiple recombinant protein products. These products ranged from engineered growth factors or fusion proteins in E. coli requiring refolding, PEGylation or other chemistries, to secreted proteins in yeast and to monoclonal antibodies from Chinese hamster ovary (CHO) cells. He also designed or completed Process Characterization and Process Validation studies with the successful registration and commercialization of biophar...
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