LCMS Bioanalysis - USA Laboratory

Semi-quantitative and quantitative protein and bioanalytical LC-MS/MS services for developing and validating complex methods

LC-MS studies can contribute important data to support preclinical and clinical drug development.

Our scientists, located at our GLP Bioanalytical Center of Excellence in San Diego, California, USA, have extensive experience in the development, validation and sample analysis of bioanalytical LC-MS assays for parent drug and metabolites in a large variety of biological matrices for both preclinical and clinical programs.

Our LC-MS teams are specialists in the conduct of US FDA Good Laboratory Practice (GLP) compliant studies.

We also perform non-GLP / discovery LC-MS assays on large and small molecules. Combined with automated data capture and reporting systems, this has established our laboratory as a leading center of excellence for bioanalysis in North America. Capabilities include high throughput sample analysis, non-GLP rapid discovery phase bioanalysis, diverse types of protein LC-MS analysis using high-resolution / accurate mass (HRMS) instrumentation, clinical pharmacokinetics (PK), and toxicokinetics (TK) support, as well as specialized bioanalysis for ocular and other tissues. Core expertise includes developing and validating methods that are robust and reproducible, and employing these methods in a high throughput environment to accelerate development times for prescription medicines (Rx drugs) and generics.

Our laboratory is FDA inspected and GLP-compliant.

LCMS Bioanalysis Services:

• Method Development
• Method Validation
• Sample Analysis
• Rapid Discovery Phase Bioanalysis
• Ocular Tissue Bioanalysis
• Sample Handling and Management
• Protein Analysis using LC-HRAMS

• Immunochemistry
• Bioanalytical Services