Regulated Immunoassay Bioanalysis
Excellence in Immunoassay Analysis
With deep expertise in high-sensitivity immunoassays, we deliver accurate and reproducible biomarker data to support drug development and precision medicine initiatives. Our lab leverages cutting-edge platforms to provide customized assay development and validation, ensuring compliance with regulatory standards while accelerating timelines for our customers.
Key Services:
- Method development, transfer, and validation
- Regulated GLP pre-clinical and clinical GCP sample analysis
- Streamlined method development, validation, and sample analysis
- Expertise, customization, flexibility, and speed
- Biomarker assay development and validation based on context of use
Validated LC-MS/MS methods for sensitive, reliable analysis of small molecules, peptides, and biomarkers.
Applications: Our services support pharmaceutical analysis for diagnosis, disease monitoring, and therapeutic drug monitoring. We facilitate clinical pharmacokinetic and bioequivalence studies in drug discovery, quantitation based on antigen-antibody reaction mechanisms, and ELISA applications including HIV, hepatitis, and mycobacterial antibody detection.
Technical Note: ELISA (Enzyme-Linked Immunosorbent Assay) uses specific immunosorbent material to absorb either antigen or antibody components.
Instrumentation: We utilize advanced technologies, including:
- MSD (MESO QuickPlex SQ 120MM Model 1300)
- Plate readers (Tecan Infinite M200 Pro and Infinite M Nano)