Whitepaper covers 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. Rapid microbial methods are increasingly being used by cell therapy developers motivated by particularly short production schedules and product shelf life, and has grown to include raw material providers interested in reducing inventory hold times.