ROCHE CORPORATE SESSION Overcoming the inertia; in-house abbreviated qualification of commercial mycoplasma detection kits for your CGT products
Friday, June 2, 2023 12:45 PM - 01:45 PM
Room 242AB
Corporate Session
Overcoming the inertia; in-house abbreviated qualification of commercial mycoplasma detection kits for your CGT products
Chair
Birgit Rogell, Product Manager, Roche CustomBiotech, Germany
Speakers
Sowmya Viswanathan, PhD, Scientist, University Health Network, Associate Professor, University of Toronto, Canada
Dr. Birgit Rogell, Product Manager, Roche Custombiotech, Germany
Detection of mycoplasma contamination using sensitive and validated tests is a regulatory requirement for all investigational and commercial cell and gene therapy products. In this tutorial, we will discuss the adoption of a commercially available validated mycoplasma detection kit for in-process and release testing of an investigational cell therapy product. Briefly, an abbreviated qualification plan, developed in consultation with regulators, was used to qualify the already validated kit. We discuss the details of the qualification plan, the justification for the minimal qualification and the interactions with the regulators to get their approvals. The in-house qualification was done in an academic setting with minimal resources and represents the basis for an approach that other investigators and sponsors can adopt and adapt.
Chair
Birgit Rogell, Product Manager, Roche CustomBiotech, Germany
Speakers
Sowmya Viswanathan, PhD, Scientist, University Health Network, Associate Professor, University of Toronto, Canada
Dr. Birgit Rogell, Product Manager, Roche Custombiotech, Germany
Detection of mycoplasma contamination using sensitive and validated tests is a regulatory requirement for all investigational and commercial cell and gene therapy products. In this tutorial, we will discuss the adoption of a commercially available validated mycoplasma detection kit for in-process and release testing of an investigational cell therapy product. Briefly, an abbreviated qualification plan, developed in consultation with regulators, was used to qualify the already validated kit. We discuss the details of the qualification plan, the justification for the minimal qualification and the interactions with the regulators to get their approvals. The in-house qualification was done in an academic setting with minimal resources and represents the basis for an approach that other investigators and sponsors can adopt and adapt.
Sponsored by:
Sowmya Viswanathan PhD
Scientist at the Osteoarthritis Program/Associate Professor at the Institute of Biomedical Engineering and Department of Medicine
University Health Network
Speaker
Scientist at the Osteoarthritis Program/Associate Professor at the Institute of Biomedical Engineering and Department of Medicine
University Health Network
Speaker