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    Gene therapy, cell therapy and vaccine research have led to an increased use of qPCR/ddPCR in bioanalytical laboratories. CROs are progressively undertaking the development and validation of qPCR and ddPCR assays. Currently, however, there is limited regulatory guidance for the use of qPCR and a complete lack of any regulatory guidelines for the use of the newer ddPCR to support regulated bioanalysis. Hence, the Global CRO Council in Bioanalysis (GCC) has issued this White Paper to provide; 1) a consensus on the different validation parameters required to support qPCR/ddPCR assays; 2) a harmonized approach to their validation and 3) a consistent development of standard operating procedures (SOPs) for all the bioanalytical laboratories using these techniques.

    Citation

    Mark Wissel, Martin Poirier, Christina Satterwhite, John Lin, Rafiq Islam, Jennifer Zimmer, Ardeshir Khadang, Jennifer Zemo, Todd Lester, Marianne Fjording, Amanda Hays, Nicola Hughes, Fabio Garofolo, Rudolf Guilbaud, Elizabeth Groeber, Heidi Renfrew, Kelly Colletti, Mathilde Yu, Jenny Lin, Xinping Fang, Santosh Shah, Wei Garofolo, Sumit Kar, Roger Hayes, John Pirro, Cheikh Kane, Marsha Luna, Allan Xu, Stephanie Cape, Mark O'Dell, Robert Wheller, Hanna Ritzen, Jennifer Vance, Esme Farley, Katie Matys, Edward Tabler, William Mylott, Moucun Yuan, Shane Karnik, Troy Voelker, Ira DuBey, Clark Williard, Jing Shi, Jim Yamashita. Recommendations on qPCR/ddPCR assay validation by GCC. Bioanalysis. 2022 Jun;14(12):853-863

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    PMID: 35703321

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