Analytical strategies for sterility and mycoplasma testing in biotherapies: from early development to production scale-up
Apr
4
2024
On demand

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

Thursday 08:00 PDT / 11:00 EDT / 16:00 BST / 17:00 CEST
Sponsor
Analytical strategies for sterility and mycoplasma testing in biotherapies: from early development to production scale-up

Biotherapies, and especially cell therapy products, are required to have sterility and mycoplasma testing. Developing an analytical strategy to test for impurities such as mycoplasma can be daunting. Which type of analytical testing can work in an early stage of therapeutic development and then be scaled to meet the challenges later in the production process?

Leveraging rapid mycoplasma and sterility detection techniques can help provide confidence in the final product by assisting in the detection of potential contamination earlier in the production process.

In this webinar, you’ll learn about:

  • Regulatory guidelines for impurity testing for cell therapies
  • How to overcome the challenges of other/traditional testing methods
  • The features and benefits of using rapid detection techniques
  • How these techniques can be scaled from therapy development through the production process
Sharon Rouw
Sharon Rouw
Sr. Product Manager, Bioproduction Group - Pharma Analytics at Thermo Fisher Scientific
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
Michael Brewer
Director, Global Principal Consultant, Regulatory for the BioProduction Group (BPG) at Thermo Fisher Scientific
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.

SPEAKERS

Sharon Rouw
Sharon Rouw
Sr. Product Manager, Bioproduction Group - Pharma Analytics at Thermo Fisher Scientific
Michael Brewer
Michael Brewer
Director, Global Principal Consultant, Regulatory for the BioProduction Group (BPG) at Thermo Fisher Scientific

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