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.

Denis has led protein therapeutic development teams for Pfizer and other companies spanning nearly 20 years, and includes 4 years leading the successful introduction of several validated GMP animal health vaccines.

He has a detailed knowledge of the CMC milestones on the path to Regulatory approval, including alignment with clinical studies outcomes. Having worked extensively with third party organizations at various stages of development and testing, his knowledge of the drug development process, CMC strategy, quality management systems and business priorities during outsourcing of product candidate technologies and services was essential for product progression. He has directed upstream microbial and mammalian production technology teams using stainless steel and single use bioreactors, is recognized as a downstream bioprocess expert, and personally directed the successful tech transfer and scale up to pilot and GMP commercial scale of over 12 protein products.

International experience was obtained from previous development, transfer and manufacturing projects in the US, Ireland, Sweden, a CMO in England and recently China, to establish new production technologies and analytical methods to meet tight timelines.

Examples of projects completed:

  • Developed and successfully transferred and scaled up engineered growth factors or fusion proteins in E. coli requiring refolding, PEGylation or other chemistries.
  • Purification of secreted proteins in yeast from high solids fermentations
  • Development of upstream and downstream technologies of monoclonal antibodies from CHO cells
  • Designed and completed several Process Characterization studies and Process Validations for registration and commercialization.
  • Invited speaker on multiple occasions, member of the scientific organizing committee for the RP-HIC conference.
  • Extensively published author and referee and has received awards for his publications.