Bionique Presentation: Mycoplasma Testing and Validation Strategies for Cell and Gene Therapies
Thursday, May 30, 2024 06:15 PM - 06:30 PM
Exhibit Hall - Theatre A
Presenter
The acceleration in the clinical and commercial development of cell and gene therapies (CGTs) have provided life-extending and life-saving treatments for conditions ranging from genetic disorders to cancer. Encompassed within the CMC activities is mycoplasma testing which is critical in product manufacturing and lot release to ensure the quality of the therapy and safeguard the patient. For autologous products and a myriad of other CGT products that have limited shelf life and batch sizes, the validation and implementation of a rapid mycoplasma test is necessary, which requires an understanding of key considerations of technical, scientific, quality and regulatory factors.
Session Objectives
- Lori Daane, PhD, Chief Scientific Officer, Bionique Testing Laboratories, USA
The acceleration in the clinical and commercial development of cell and gene therapies (CGTs) have provided life-extending and life-saving treatments for conditions ranging from genetic disorders to cancer. Encompassed within the CMC activities is mycoplasma testing which is critical in product manufacturing and lot release to ensure the quality of the therapy and safeguard the patient. For autologous products and a myriad of other CGT products that have limited shelf life and batch sizes, the validation and implementation of a rapid mycoplasma test is necessary, which requires an understanding of key considerations of technical, scientific, quality and regulatory factors.
Session Objectives
- Key considerations in the development and implementation of a mycoplasma testing strategy for cell and gene therapies.
- Overview of phase-appropriate approach for validation of a rapid mycoplasma testing method.
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