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Mike Brewer
Director, Global Principal Consultant, Regulatory at Thermo Fisher Scientific


Michael Brewer is the Director, Global Principal Consultant, Regulatory for the BioProduction Division (BPD) at Thermo Fisher Scientific. In this role, Michael is responsible for providing global support to BPD customers and serving as the regulatory thought leader and expert across all technology areas within BPD. Prior to moving to this role, he led the team responsible for product applications including microbiology, analytical sciences, and quality control. The products are fully integrated solutions for glycan profiling, bacterial and fungal identification, mycoplasma and viral detection, and host cell DNA and protein quantitation. Michael has over 30 years’ experience in the biopharma industry, including Scios, Synergen, and Amgen in a variety of roles including discovery research, analytical sciences, and quality control. Prior to joining Thermo Fisher Scientific, he led a group at Amgen that developed qualified, validated, and implemented molecular methods for host cell DNA quantitation, contaminant (mycoplasma, virus, and bacteria) detection, contaminant identification, strain typing, and genotypic verification of production cell lines.

Agenda Sessions

  • Live Speakers Discussion Forum

  • Validation design and results for qPCR based residual host cell DNA testing for biologics