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Kurt Brorson, PhD
Vice President, Technical at Parexel International

Profile

Kurt Brorson, Ph.D. is Vice President, Technical, at PAREXEL International where he provides a full range of consulting services for the quality of biopharmaceuticals, with specific expertise in biomanufacturing, biotech product quality and risk-mitigation, biosimilars, transition products and viral safety/viral clearance.  He also acts as a trusted advisor to clients, often on issues that lack precedent or are not clearly defined.   Strategist known for inspirational leadership and successful oversight of cross-functional teams engaged in complex research, quality, and process improvement initiatives.  Engaged in constant industry standards ideation and creation, technical report building, and program development that educated the whole industry

Prior to joining PAREXEL, Dr. Brorson was a Lab Chief in CDER/OPQ/Office of Biotechnology Products (OBP) at the FDA, with 26 years in the Agency.  At FDA, he was a reviewer, inspector and laboratory scientist, running a mission-focused research program project widely considered to be world-class in virus retentive filtration and viral safety of biotech products.  Dr. Brorson received his BA. in Biology from University of Chicago (Chicago IL) in 1984 and Ph.D. in Molecular Biology from California Institute of Technology (Pasadena CA) in 1990.

Agenda Sessions

  • Exploring the Linkage Between Cell Culture Process Parameters and Downstream Processing Utilizing a Placket-Burman Design for a Model Monoclonal Antibody

    11:20am
  • Regulatory Strategies for Continuous Processing

    11:20am