Past, Current, and Future State
November 24, 2021
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. Its high sensitivity (0.1 CFU/mL detection) is achieved through multiple subcultures and observations of culture media and agar plates over the course of 28 days. While awaiting 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.
Pressure to reduce long turnaround times (TAT) has spurred innovation through the use of nucleic acid technologies (NAT), such as real-time PCR. With guidance from the European pharmacopeia chapter (2.6.7), multiple biopharmaceutical companies have successfully validated real time PCR methods for testing. In addition to the benefit of reducing TAT from 28 days to a single day, cost to the patients are reduced from lowering FTE, reducing storage costs, and creating a more agile supply chain network.
TAT reduction becomes even more critical in the new cell and gene therapy landscape, where some of these medicinal products are customized from the patients themselves. Furthermore, integration of testing built into the production line can improve efficiency and further expedite live saving medicines. As innovate therapies emerge, quality control tests must also become creative to adapt to these new modalities. That includes mycoplasma testing.
Dr. Kenneth Tai
Senior Manager, Analytical Science and Transfer
Dr. Lori Daane
Sr. Director, Scientific Affairs
Senior Manager Global Analytical Science and Technology (gASAT), Global Quality Control