Biomarker Immunoassay Development Services

Biomarkers are objective, quantifiable biological indicators that reflect human physiological changes, pathological conditions and therapeutic responses. They support key drug development workflows, including target validation, efficacy evaluation, patient stratification and personalized medicine implementation. As a critical translational link between preclinical research and clinical application, biomarkers power the whole drug R&D process. Through the closed-loop cycle of screening, validation, application and iteration, they optimize traditional development models, reduce research uncertainties and clinical failure risks, shorten R&D cycles, and enable more efficient, accurate and standardized modern drug development.
Service Offerings

Exogenous / Endogenous Standards

Exogenous / Endogenous Standards

Single B-cell Antibody Pair Screening

Single B-cell Antibody Pair Screening

Method Development and Validation

Method Development and Validation

Method Transfer to GLP/GCP Laboratories

Method Transfer to GLP/GCP Laboratories

Core Technical Advantages

Antibody Pair Screening: Select biologically active antigens as immunogens; high-throughput single B-cell screening improves sensitivity and specificity by over 30%, accelerating R&D efficiency.

Assay Development & Validation: Fit-for-purpose biomarker assay development and full validation.

Multi-Platform Support: ELISA / FACS / TR-FRET / IHC covering cells, blood, and tissues.

Kit Production: GMP-compliant manufacturing with full IVD-grade quality control ensures batch-to-batch variation ≤8%.

RUO-to-IVD Transition: Professional regulatory support shortens FDA/CE certification timelines by 6–8 months.

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Cooperation Process

Cooperation Process

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