Analytical strategies for sterility and mycoplasma testing in biotherapies: from early development to production scale-up

Sharon Rouw is a Senior Product Manager with the BioProduction Group (BPG) at Thermo Fisher Scientific. She is part of the Pharma Analytics business, a team responsible for the development and commercialization of testing applications for microbiology, analytical sciences, and quality control. The products are fully integrated solutions for bacterial and fungal identification, mycoplasma and viral detection, and host cell DNA and protein quantitation. In this role, Sharon is responsible for managing the MycoSEQ™ Mycoplasma Detection products used by BioProduction customers worldwide. Sharon has over 20 years of experience across the biopharma, pharma, and life science industries. Prior to joining Thermo Fisher Scientific, she served in a variety of roles including product management, marketing management, and R&D for companies such as MilliporeSigma, Integrated DNA Technologies, and Pfizer. Sharon holds a master’s degree in cell & molecular biology and an MBA from Washington University.

Michael Brewer is the Director, 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 moving to this role, he led the pharma analytics business, a team responsible for the 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, with discovery research, analytical sciences, and quality control roles at Scios, Synergen, and Amgen. 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. 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 the implementation of new methods.