Keystone Bioanalytical is a GLP-compliant CRO specializing in quantitative LC-MS/MS method development, validation, and analysis, as well as drug metabolite profiling and identification.

We provide bioanalytical and MetID support for discovery, preclinical, and clinical stage studies. These include ADME, PK, toxicology and clinical trial studies.

Services | Assays | Biomarkers | Antibiotics | Drugs | Synthesis

See our List of Validated Assays and our Custom Synthesis Services

Support of small, large, and/or multiple clinical studies. Sample receipt, sample tracking, and sample suppository services. Method development, validation, and sample analysis performed in full compliance with regulatory guidelines. Complete quality assurance auditing at each stage of study. Bioanalytical report for regulatory submission with compliance statements. Interim results reporting and expedited bioanalysis available.

• Single or multiple analyte method development.
• Complete method validation or method transfer
• Compliance with FDA and white paper guidances
• Quality control sample and stock solution stability confirmation
• Incurred sample reproducibility
• Established batch acceptance criteria
• Whole blood stability for sample collection intergrity

• Bioanalytical analysis for toxicokinetics for non-clincal laboratory studies
• Method development, validation, and sample analysis performed in full compliance with regulatory guidelines
• Sample storage and solution stability confirmation. Incurred sample reproducibility evaluation
• Complete and thorough quality assurance audits throughout study
• GLP compliant bioanalytical report and documentation
• Sample storage stability, solution stability and incurred sample reproducibility

• Dependable and expedient bioanalytical support for research and development studies such as ADME and pharmacokinetic (PK) studies
• Method development and analysis in all types of biological matrices
• Results provided on the next business day on request
• Data interpretation and elucidation
• Support for small or on-going studies

• Metabolic stability screening in liver microsomes
• Metabolite stability screening in liver S9
• Metabolic soft-spot analysis in liver microsomes
• Metabolite profiling and characterization in liver S9
• Reactive metabolite screening in liver microsomes
• Metabolism comparison in liver microsomes across species
• Screening of oxidative and conjugate metabolites in liver microsomes
• Detection and structure characterization of payload-related components released from ADC in liver S9 incubation
• Metabolite profiling and structure characterization of PDC in liver microsomes and S9
• Metabolite profiling and identification in plasma, urine, feces, and bile samples from human and animals
• MIST evaluation by comparing metabolite exposures in human and Tox species
• ADME study in BDC rats or other animals by profiling and identifying metabolites in plasma, urine, bile and/or feces

Keystone Bioanalytical has extensive experience at applying bioanalytical techniques for the analysis biomarkers. These include renin activity, fatty acid analysis, aldosterone, angiotensin II, GLP-1, T3 T4, and others. Analysis of biomarkers can be performed in a regulated setting or for research and development.

Keystone Bioanalytical specializes in the analysis of tissue samples for drugs and biomarkers. Our automated tissue homogenization provides optimal accuracy and precision for tissue extractions together with rapid sample processing.

Keystone Bioanalytical has expanded our ligand binding capabilities which include multiple biomarkers.