Download Molecular Biology - Charles River Laboratories

Molecular Biology
Regulatory guidance recommends the inclusion of pharmacogenomic
investigations during the drug or biological product development process,
therefore you need a partner that can offer you the most advanced and reliable
assays as well as the flexibility to tailor them to your specifications. Leveraging
the latest technologies such as real-time quantitative PCR (qPCR) and real-time
reverse transcriptase qPCR (RT-qPCR), Charles River performs a comprehensive
array of genomics-based assays to support all phases of drug development,
from discovery and preclinical studies through clinical trials, in either singleplex or
multiplex formats.
Our Facilities
Our molecular biology facilities have custom-designed, dedicated laboratories
with separate sample processing (e.g., nucleic acid extraction), reagent
preparation and amplification/product detection areas to minimize the possibility
of cross-contamination.
We can isolate and purify DNA and RNA from a variety of tissues, body fluids, cells
in culture or any other biological sample. Our extraction procedures are optimized to
provide the highest quality real-time qPCR results; both quality and yield of extracted
nucleic acid samples are assessed prior to being used in the qPCR assay.
Technical Capabilities
Charles River has invested in leading-edge, real-time qPCR platforms capable of
supporting multiple fluorescent chemistries, such as TaqMan® and SYBR® Green,
to facilitate the development of the most sensitive and robust qPCR assays for
your products. Our real-time qPCR platforms are also capable of performing
allelic discrimination assays using next-generation TaqMan® probe chemistry.
Regulatory Expertise and Compliance
Charles River has vast experience in the development of assays for gene
expression studies or target gene detection. Our expertise includes assay
development, sample processing, and data analysis and interpretation.
Molecular assays are validated to Food and Drug Administration (FDA),
Organisation for Economic Co-operation and Development (OECD), Ministry
of Health, Labour and Welfare (MHLW) and International Conference on
Harmonisation (ICH) guidelines, and are compliant with GLP or GMP, as required.
Services
• Allelic discrimination assays (SNP genotyping)
• Assay feasibility, development and validation
• Biological sample analysis
• Biomarker assessment
• Biosafety testing
-- Adventitious agents testing by
qPCR/ RT-qPCR
-- PCR-based reverse transcriptase testing
-- PCR-based mycoplasma testing
• Cell line authentication
-- Barcode of Life sequence analysis
-- Human and Vero short tandem repeat
(STR) analysis
• Cell line characterization (mammalian, fungal,
bacterial)
-- Restriction endonuclease analysis
-- Gene copy number
-- Recombinant gene sequencing
-- Transcript sequencing
• Cytokine mRNA profiling in immune response
• Gene expression analysis
• Genomic and plasmid DNA isolation
• Microbial contaminant identification by
sequence analysis
• Nucleic acid therapeutic assessments
-- Biodistribution studies
-- Pharmacokinetics
• Residual DNA detection by qPCR or
hybridization analysis
• RNA isolation and integrity assessment
[email protected]
www.criver.com
© 2013, Charles River Laboratories International, Inc.