Rapid PCR-based assays for mycoplasma and sterility testing offer cell therapy developers many advantages over culture-based tests.
Cell therapy innovators are facing significant challenges as they strive to accelerate the testing of their cell therapies while maintaining the high standards of safety, purity, and quality required by global regulatory agencies.
Polymerase chain reaction (PCR)-based methods for mycoplasma and sterility testing offer several advantages over traditional culture-based assays, including the ability to detect contaminants in one day versus the two- to four-weeks required for growth-based testing. Real-time quantitative PCR testing for mycoplasma and sterility detection can be integrated into analytical workflows, with automated sample preparation that helps to improve speed, flexibility and consistency.
This report provides a practical roadmap for modernizing safety testing practices in cell therapy development by adopting molecular testing methods. Topics include:
- The scientific benefits of PCR-based assays for detecting mycoplasma or other microbial contaminants (including bacteria and fungi)
- Operational advantages of switching to molecular methods, including reductions in time, sample sizes, equipment and personnel training required to complete safety testing
- Guidance on how analytical development teams make the transition to PCR-based mycoplasma and sterility testing
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