Bionique in Association with ThermoFisher and American Pharmaceutical Review Present: Key Considerations for Implementing Rapid Microbial Methods for Mycoplasma Detection.

This white paper explains 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.