PDA Metro: The Future of Mycoplasma Testing is Now: Sample to Results in Less than One Hour

PDA Metro invites you to a virtual discussion: The Future of Mycoplasma Testing is Now: Sample to Results in Less than One Hour

Abstract: Compendial methods require ≥28 days to generate mycoplasma testing results leading to an inefficient supply chain network and huge costs for bioproduction manufacturers. Turnaround times (TATs) become even more critical for testing cell & gene therapy (CAGT) products that have a short shelf-life and can’t be tested using compendial methods.

Innovation has delivered shorter TATs by using nucleic acid techniques (NAT), such as real-time PCR that provides results in ~ 5 hours, however these systems require specialized laboratories and often the data must be confirmed by molecular biologists. In addition, they are open systems and prone to contamination and human error.

Fully automated sample-to-answer closed-PCR systems providing results in ~1 h have been developed in the past decade and are commonly used in clinical diagnostics, public health and biodefense.  Only recently has there been such a system available for pharmaceutical applications for testing bioproduction and CAGT samples allowing for at-line testing with little to no technical skills required. The future of mycoplasma detection is now using the BIOFIRE® Mycoplasma test.

In this webinar, a historical evolution of the past, future, and present testing for mycoplasma will be presented. Two protocols have been developed and validated for the BIOFIRE Mycoplasma test allowing it to be used as both an in-process and end-product release method. Data will be presented for detection limit, specificity, robustness, repeatability, and ruggedness. Market evaluation data from bioproduction companies including false-positive/false-negative rates and inoculation study results testing high density CHO cell products will be presented.

Lori Daane joined bioMérieux in 2016 and is the Sr. Director of Scientific Affairs. She has over 30 years’ 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 where she helped develop and launch a number of new & improved products that helped customers minimize reagent waste and expand the product matrices tested. 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.