Mycoplasma Testing: Past, Current, and Future State

29th April 2021 | 10:00am PST / 1:00pm EST / 6:00pm GMT | Kenneth Tai, Senior Manager, Analytical Science and Technology at Kite Pharma, Lori Daane, Pharma Microbiology Scientific Director at bioMérieux and Alexander Bartes, Senior Manager Global Analytical Science and Technology (gASAT), Global Quality Control, Roche Pharma |WATCH FOR FREE

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 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.

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, costs 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 innovative therapies emerge, quality control tests must also become creative to adapt to these new modalities.  That includes mycoplasma testing.

Presented by Kenneth Tai, Senior Manager, Analytical Science, and Technology at Kite Pharma

Kenneth Tai received his Ph.D. in genetic, molecular, and cellular biology at the University of Southern California with a focus on the 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.

Ken was a scientist at Genentech 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.

In January 2021, Ken joined Kite Pharma, evaluating new technologies in microbiology and applying them strategically within the network. His primary goal is to continuously improve and adapt to the ever changing landscape in biologic therapeutics.


Followed by Lori Daane, Pharma Microbiology Scientific Director at bioMérieux

Lori Daane is the Director of Scientific Affairs at bioMérieux and has over 30 years of experience in clinical, environmental and industrial microbiology.  She is a technical expert on rapid and alternative methods and provides scientific support to the Healthcare Business in North America. Prior to joining bioMérieux, Lori worked for 11 years at Celsis in a variety of technical roles including VP of Scientific Affairs and Reagent Development.   Lori received her Ph.D. from the University of Minnesota in Microbial Ecology and performed postdoctoral research at Rutgers University and Los Alamos National Laboratory. She also holds a Master’s degree in Limnology and a Bachelor’s degree in Medical Technology.

Followed by Alexander Bartes, Senior Manager Global Analytical Science and Technology (gASAT), Global Quality Control, Roche Pharma

Alexander Bartes studied biotechnology at the University of Applied Science Aachen/Juelich, Germany. After completion of his Master Thesis at Roche Bioscience, Palo Alto, CA, USA he joined Roche Diagnostics GmbH, Penzberg, Germany in 2002 working in the R&D unit of Roche Applied Science (RAS). In 2008, he took over the lead of Roche Custom Biotech’s Training and Application lab. In addition, he was responsible for the development of qPCR/NAT based assays and Kits for RAS Custom Biotech as well as for the RAS Life Science Research Market. In 2013, he moved on to Roche’s Pharma business unit Pharma Biotech Penzberg as Manager QC responsible for PCR/NAT based in-process control and release testing in the Roche/Genentech network. In 2018, he moved on to Roche Pharma Global Quality Control as Senior Manager QC and will continue in his current role as Lead of the Analytical Technology Center for Adventitious Agents Testing.

Sponsored by BioMérieux & Roche CustomBiotech

About BioMérieux

With more than 50 years of pioneering diagnostics, the people of bioMérieux understand the challenges you face when it comes to ensuring product quality and are proud to offer the most comprehensive portfolio of solutions for microbiology Quality Control of biopharmaceuticals and ATMPs.  Choosing the right microbiology diagnostic can boost efficiency with in-processes testing and automation simplifies the testing processes, reduces human error, and helps ensures data integrity. Rapid, simple, at-line testing of key parameters allows in-process tests to be performed closer to the production environment and provides certainty that your manufacturing process is secure.


About Roche

At Roche CustomBiotech, we believe the advancement of your products requires building unprecedented manufacturing processes. We support your development and manufacturing activities by providing high-quality raw materials that reduce uncertainties and providing quality control analytical tools that fit your specific manufacturing requirements.  More than a supplier, we aim to be your partner in bringing the next generation of your products to market.  In support of our goal to help you advance, building on almost two decades of mycoplasma testing innovation, Roche CustomBiotech offers a mycoplasma testing portfolio primed to revolutionize your mycoplasma QC testing strategy and meet your lab’s evolving throughput and application needs.  The MycoTOOL PCR-based testing kits have been used in test methods validated according to E.P. 2.6.7 NAT validation guidelines. These testing kits have been chosen by many manufacturers for a variety of QC testing points, including for their mycoplasma lot release methods that they have validated and received acceptance from certain regulatory agencies for select clinical or commercial products.  During this event, Roche CustomBiotech brings an industry expert to share insight on a global biopharma manufacturer’s need for and experience using our mycoplasma real-time PCR test to meet evolving QC testing requirements.

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