GMP/GLP Validated Quantitative Real-Time PCR at Charles River
September 20, 2011 - Quantitative reverse transcriptase polymerase chain reaction (Q-RTPCR) and quantitative polymerase chain reaction (Q-PCR) are considered the “gold standard” methods for measuring individual gene expression and determining the quantity of a specific DNA, respectively. With the increasing importance of genomic biomarker correlation in disease progression and drug treatment effects, Q-RTPCR has become a valuable method for use in clinical studies, and Q-PCR is the method of choice for detecting therapeutic plasmid or viral load in tissue derived from biodistribution or persistence studies.
Charles River performs a comprehensive array of quantitative real-time PCR assays to support all phases of drug development. Our Preclinical Services group focuses on GLP-compliant DNA detection and gene expression assays, whereas our Biopharmaceutical Services group focuses on lot release as well as product and cell line contamination assays performed to GMP.
Our Molecular Biology groups operate Applied Biosystems 7900HT Real-Time PCR Systems (with SDS Enterprise Edition software) and BioRad Opticon Chromo4™ systems. These systems are compatible with many different chemistries, including SYBR® Green I, Molecular Beacons, TaqMan® Probes, Scorpion® Probes and the Amplifluor® System. All of our real-time PCR systems and supporting software have undergone complete computer system validations, satisfying the requirements of US and European regulatory authorities.
Additionally, real-time PCR assay validations are performed for each Sponsor-specific DNA or gene expression target. Real-time PCR assays are validated for performance-related parameters, such as intra- and inter-assay precision and accuracy, range of response, limit of detection (LOD), specificity and selectivity, as well as short- and long-term and freeze-thaw matrix stabilities. Real-time PCR assays are validated to Food and Drug Administration (FDA)/International Conference on Harmonisation (ICH) guidelines and are in compliance with Good Laboratory Practice (GLP) regulations, as required.
Besides our portfolio of regulated assays, Charles River Research Models and Services offers non-GxP PCR assays for infectious agent detection and genetic testing. Furthermore, our Avian Vaccine Services group offers PCR testing for avian pathogens.
Charles River has considerable scientific and technical expertise in the development of quantitative real-time PCR assays. Our expertise includes assay development and validation/qualification, sample processing, and data analysis and interpretation.
For additional information about our quantitative real-time PCR capabilities, please contact us at 1.877.CRIVER.1 or askcharlesriver@crl.com.
Related Info