Charles River offers non-GLP and discovery bioanalytical services, either in support of studies conducted in-house or as a stand-alone service, with the flexibility to meet the timelines and diverse needs for discovering the best drug candidate.
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Our research-grade assay approach via LC-MS/MS can quickly analyze samples for compound ranking. Once a lead candidate has been selected in the discovery analytical process, these methods can be transferred to method development for GLP bioanalytical testing including feasibility, validation, and preclinical and clinical sample analysis.
In discovery bioanalysis, the lab is often blind to analyte structure. To proceed quickly and intelligently, we start with a default protein precipitation LC-MS/MS method that is applicable to the vast majority of small molecule compounds, eliminating the need for method development or qualification. Features of the methodology include:
- Assay range of 1–5000 ng/mL (default; can be modified as required)
- Front and back calibration standards consisting of nine different concentrations
- Sample aliquot volume default of 10 µL of biofluid (particularly important for serial mouse sampling)
- Addition of gradient selection based on retention time
The use of bracketing calibration standards is crucial in discovery to control potential divergence (drift) that can occur due to buildup of matrix components or dosing vehicle. This effort is further aided by our use of small sample volumes, which minimize these adverse effects, plus our use of the latest technologies, such as UPLC and Tandem MS (MS/MS), to achieve appropriate sensitivity even with such small sample aliquots.
The key to balancing the competing demands of data quality, speed of execution and cost is an understanding of the data quality required to satisfy experimental objectives. Charles River offers a suite of standardized, fit-for-purpose non-GLP research-grade assays to address client needs across the drug continuum. Additionally, for studies with multiple matrices, we can flexibly work with you on alternative assay scenarios to effectively manage cost and minimize time while ultimately satisfying data-quality requirements. We can perform studies using client-defined procedures and acceptance criteria to ensure data comparability, consistent with our philosophy of providing services as a true extension of your internal capabilities and processes.
Experience has taught us that great design must be followed by great execution. To ensure this, we have designed a number of diagnostic probes embedded into our sample analysis to assess and demonstrate the production of high-quality data. Diagnostic probes are further used to identify, diagnose and troubleshoot areas where data quality may be compromised, enabling us to solve problems and re-establish quality quickly. Examples of these probes include:
- Multiple internal standards (to accommodate a range of retention times and to assess suppression)
- Multiple transitions for each analyte
- Matrix effect probe (to determine if matrix or vehicle may be causing quantitation interferences)
- Bioanalysis stability probe (to assess short-term stability of the analyte in study matrix)