Mycoplasma Testing: Past, Current, and Future State

29th April 2021 | 10:00am PST / 1:00pm EST / 6:00pm GMT | Kenneth Tai, Quality Control Scientist, Global Analytical Science Technology at Genentech |BOOK FREE SEAT FOR THIS WEBINAR

For nearly 30 years, mycoplasma testing for biologics have 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 life saving medicines.  As innovate therapies emerge, quality control tests must also become creative to adapt to these new modalities.  That includes mycoplasma testing.

Presented by Kenneth Tai, Quality Control Scientist, Global Analytical Science Technology at Genentech

Kenneth Tai received his Ph.D. in genetic, molecular and cellular biology at the University of Southern California with a focus on structure/function of antimicrobial peptides.  In 2012, he joined Life Technologies (now Thermofisher) as a technical applications scientist to support real-time PCR technologies and reagents.

In 2014, Ken joined the global adventitious agents testing group at Genentech where he performed method validations and transfers of real-time PCR-based assays to replace the traditional cell culture-based methods for the detection of adventitious agents.  He has successfully validated multiple clinical and commercial products for real-time PCR testing of Mycoplasma. Leptospira, and MVM.

Currently, Ken is a scientist in the global analytical science and technology group where he is focused on the implementation of innovative analytical methods to quality control.  His major project will be evaluating next generation sequencing as a platform to replace in vivo and in vitro viral screening of CHO-derived cell banks and products.

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