Upcoming webinar

Mycoplasma testing regulatory guidance and strategies for cGMP cell and gene therapy manufacturing

Tuesday July 19th 2022 08:00 PDT / 11:00 EDT / 16:00 BST / 17:00 CEST
Mycoplasma testing regulatory guidance and strategies for cGMP cell and gene therapy manufacturing

Mycoplasma, the smallest known free living, self-replicating microorganisms, are potential contaminants of mammalian cell cultures, including biotherapeutic manufacturing cell cultures. As such, these cultures must be tested and are required to be free of Mycoplasma. Regulatory guidance globally for mycoplasma testing has evolved, from strictly requiring culture-based testing methods to now accepting rapid molecular methods, including real-time quantitative PCR based methods. Rapid time to results enabled by qPCR-based tests can be critical for short shelf-life therapeutics such as cell and gene-modified cell therapies. These modalities often present additional challenges that require expertise to interpret and apply to achieve the required sensitivity, specificity, and robustness expected for use in cGMP manufacturing processes.

In this webinar, an overview of analytical requirements for cell and gene therapy process will be presented, with an in-depth focus on regulatory guidance for mycoplasma testing and the particulars to the production of cell and gene therapies. With over a decade of field support of qPCR-based mycoplasma test method qualification, validation and implementation for lot-release, we will address common challenges such as the selection of a representative sample and techniques for sample preparation to help achieve regulatory requirements

Attendees will receive:

  • An in-depth review and analysis of mycoplasma testing regulatory guidance applied to cell and gene therapy manufacturing from worldwide regulatory bodies
  • Details of a highly sensitive, specific, and robust method for rapid mycoplasma detection with a strong regulatory acceptance track-record for lot-release testing and as well as in-process testing
  • Tips and tricks for cell and gene therapy customers developed over 10 years of field support from sample selection, preparation, and validation guidance

Michael Brewer

Director, Global Principal Consultant, Regulatory, BioProduction, 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 BPD. Prior to moving to this role, 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’ 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. 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.



Michael Brewer
Michael Brewer
Director, Global Principal Consultant, Regulatory for the BioProduction Group (BPG) at Thermo Fisher Scientific

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