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