New PCR Assay for Detection of Mycoplasma that Meets New FDA Vaccine Guidance
May 4, 2010 – Recently, the U.S. Food and Drug Administration (FDA) issued new guidance on cell substrates and other biological materials in vaccines that target infectious disease (Guidance for Industry: Characterization and Qualification of Cell Substrates and Other Biological Materials Used in the Production of Viral Vaccines for Infectious Disease Indications, FDA, CBER, February 2010). We now offer a validated assay that meets the new FDA guidance for detection of mycoplasma, as well as the requirements of the European Pharmacopoeia.
In the new guidance, the FDA specifically allows and in some cases necessitates the use of polymerase chain reaction (PCR)-based assays for mycoplasma detection, as long as the assays are properly validated. Mycoplasma contamination of cell cultures can compromise the safety of vaccines and other products and is a major economic and safety risk for biopharmaceuticals from the research and development phase all the way to the product phase.
Mycoplasma are difficult to detect and almost impossible to remove due to their size and flexibility, which allows them to pass through the microfilters used in cell culture. PCR is an established, highly sensitive, reliable and time-efficient method for the detection and identification of contaminants such as mycoplasma.
Our PCR assay targets mycoplasma RNA using reverse transcriptase-PCR technology with sequence-specific primers and dual-labeled fluorescent probes developed at Charles River.
Since RNA is more labile than DNA, targeting RNA should decrease the detection of non-viable organisms as well as persistent residual DNA in the samples. In addition, in viable bacteria, more copies of the target RNA are expected to be present compared to the target gene copy number, thereby increasing the sensitivity of the assay.
This PCR assay is already available from Charles River and is part of the extensive portfolio of expert and customized testing services that we offer to help you get your biologic to market safely and efficiently. Contact us at askcharlesriver@crl.com to learn more.
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