A Rapid and Sensitive Nucleic Acid Amplification Technique for Mycoplasma Screening of Cell Therapy Products

Molecular Therapy. Methods & Clinical Development
Lisa DreoliniRobert A Holt

Abstract

Mycoplasma species (spp.) bacteria can infect cell cultures, posing a potential threat to recipients of cell therapy products. Conventional Mycoplasma testing methods are highly sensitive but typically require a minimum of 28 days to produce results. This delay is problematic if rapid results are needed to inform treatment decisions. Nucleic acid amplification technique (NAT) methods have been gaining favor for Mycoplasma testing due to their speed and specificity; however, they must first be qualified as meeting or exceeding the sensitivity of the compendial method. We present herein a NAT method for the detection of Mycoplasma that circumvents the need for live Mycoplasma spp. in the test procedure by instead being qualified using Mycoplasma spp. genomic DNA. We have demonstrated a lower limit of detection that exceeds the regulatory requirements set by Health Canada. This assay is now being used to screen clinical cell therapy products manufactured at our center.

References

Sep 1, 1992·Clinical Infectious Diseases : an Official Publication of the Infectious Diseases Society of America·A YechouronJ G Tully
Dec 2, 2004·Biologicals : Journal of the International Association of Biological Standardization·Joyce A ElderingBarbara J Potts
Feb 13, 2010·Biologicals : Journal of the International Association of Biological Standardization·Yan ZhiGarry B Takle
Mar 9, 2010·Biologicals : Journal of the International Association of Biological Standardization·Sven M DeutschmannYvonne Knack
Apr 7, 2010·Biologicals : Journal of the International Association of Biological Standardization·Shayn E ArmstrongDaniel J Lundin
Jun 18, 2010·International Journal of Infectious Diseases : IJID : Official Publication of the International Society for Infectious Diseases·Colin R MacKenzieBirgit Henrich
Jul 13, 2012·Journal of Clinical Microbiology·Mayumi WatanabeYuichi Hasegawa
Aug 6, 2013·Biologicals : Journal of the International Association of Biological Standardization·Alena DabrazhynetskayaVladimir Chizhikov
Oct 12, 2013·Journal of Applied Microbiology·A DabrazhynetskayaV Chizhikov

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Methods Mentioned

BETA
PCR
electrophoresis
Assay

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