Charles River provides comprehensive bioanalytical support for all stages of product development, from early discovery and preclinical studies through all phases of clinical development. Our experienced chemists develop, validate, and apply quantitative methods for the determination of pharmaceutical compounds in biological samples, from small molecules to larger peptides. Methods can be transferred from sponsor laboratories and feasibility studies performed to confirm suitability for purpose. All work is conducted to GLP standards, although we can offer non-GLP study designs and reporting to reflect your specific requirements.
Significant investments in the area of bioanalysis continue to increase our capability to conduct sensitive and specific sample analysis. Our bioanalytical chemists use advanced technologies, such as 96-well plate automated sample extraction and high-throughput microcolumn analysis, to rapidly analyze sample batches of varying sizes at an industry-leading pace. Our laboratories have the latest analytical equipment to measure drug and metabolite concentrations in biological matrices such as plasma, serum, CSF, urine, and tissue using a wide range of different techniques. All studies are supported by a validated Watson™ LIMS for sample and data management. This brings a number of benefits, the most significant being improved efficiencies in the collation and reporting of data.
Analytical Methodologies
- LC-MS/MS
- LC-MS and GC-MS
- HPLC and GC
- CE
- Immunoassay techniques such as ELISA, RIA, EIA, IRMA, and DELFIA
- AAS for measurement of total metal content in biological samples
To assist in quantitative bioanalysis, our chemical synthesis group can produce non-labeled or stable isotope labeled compounds, such as deuterated or carbon-13 analogues, for use as assay internal standards. They can also assist with metabolite identification, profiling, and synthesis.