White Paper: Successfully Implementing Rapid Microbial Methods for Mycoplasma Detection

For the last several years, Bionique Testing Laboratories has been in a unique position to facilitate the adoption of rapid mycoplasma testing strategies by their clients. Predominantly cell therapy developers motivated by particularly short production schedules and product shelf life, this pool of clients has grown to include raw material providers interested in reducing inventory hold times.

This discussion will cover lessons learned throughout Bionique’s experience with guiding sponsors through the process of developing and qualifying or validating a MycoSEQ-based rapid mycoplasma testing strategy.

In this white paper you’ll learn the importance of demonstrating product-specific suitability, defining representative sample, consistent sampling protocols, accommodating volume and turnaround time constraints, and the need to establish equivalence.

Who should read: Anyone considering the adoption of a rapid mycoplasma testing strategy including assay development scientists, QC managers, Global Product Quality leads, and other CMC-focused quality professionals.

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