Mycoplasma Testing: Past, Current, and Future State

For nearly 30 years, mycoplasma testing for biologics has been performed using cell culture-based methods. The compendial mycoplasma detection method has been the gold standard in the biopharma industry. 1 CFU/mL detection) is achieved through multiple subcultures and observations of culture media and agar plates over the course of 28 days.

While waiting for the results of testing, CHO-derived antibody drug substances are stored in freezers; however, long storage times have contributed to an inefficient supply chain network resulting in huge costs.