Single Viewer: Ensuring Safety and Compliance in Advanced Biotherapies: Evolving Standards and Testing Methodologies for Mycoplasma in Cell and Gene Therapy Manufacturing

Please note: This is a Single Viewer eCast registration for one participant for this eCast for both the live and on-demand version of this eCast. If you are interested in presenting this program to a group, please see the “eCast Registration Form– Group Viewing” form on the eCast program page.

Access instructions for the live eCast will be provided via email approximately 2-3 business days prior to the live program date. Access instructions for the on-demand version of this program will be provided via email approximately 3-10 business days after the live program has occurred and the on-demand version is available.

Program Description: Mycoplasma contamination poses a significant challenge in biopharmaceutical production and cell and gene therapy (CAGT), impacting product quality, safety, and regulatory compliance. These elusive bacteria, often undetectable by routine sterility testing, can silently sabotage cell cultures, leading to costly batch failures and jeopardizing patient safety.

This program will provide the audience with comprehensive understanding of mycoplasma, its multifaceted impact, and the latest strategies for effective detection, control, and validation. The speaker will delve into:

• The Dual Nature of Mycoplasma: Explore the clinical significance of mycoplasma as a pathogen and its detrimental effects on bioproduction and CAGT processes.

• A Spectrum of Detection Methods: Discover traditional and cutting-edge testing strategies, from growth based compendial methods to widely adopted alternatives, comparing their strengths and limitations.

• Navigating the Regulatory Landscape: Stay informed about the evolving regulatory requirements for mycoplasma testing, including pharmacopeial guidelines and agency expectations, with a focus on CAGT product development.

• Phase-Appropriate Validation Strategies: Learn how to implement robust qualification and validation protocols tailored to different stages of development, ensuring compliance and minimizing risks.

This program is crucial for scientists, quality control professionals, regulatory affairs personnel, and anyone involved in biopharmaceutical production and CAGT development.