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Simple In-House Mycoplasma Testing

Method for Regulatory Expectations and

Rapid, Confident, and Actionable Results

Presenter:

Michael Brewer
Director & Global Principal Consultant, Regulatory, BioProduction Group
Thermo Fisher Scientific
 
Michael Brewer is the Director and Global Principal Consultant, Regulatory for the BioProduction Group (BPG) at Thermo Fisher Scientific. In this role, Michael is responsible for providing global support to BioProduction customers and serving as the regulatory thought leader and expert across all technology areas within BPG.
 
Prior to this, he led the Pharma Analytics Business, a team responsible for development and commercialization of testing applications for 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 of experience in the biopharma industry, having been with Scios, Synergen and Amgen in a variety of roles including discovery Research, analytical sciences and quality control.
 
Before 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. Additionally, his group supported regulatory submissions including IND, NDA, and CMC updates, regulatory inspections, NC/CAPA investigations, contamination investigations and remediation, and developed regulatory strategy for implementation of new methods.