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Bioanalytical Method Development and Validation

Robust biomarker data begins with the right bioanalytical method. WuXi AppTec offers an expansive suite of qualified and validated bioanalytical platforms to support biomarker quantification across small and large molecule programs.

Peptide Testing Services by WuXi AppTec Lab Testing Division

Small Molecule Validated Bioanalytical Methods

In Vitro Studies for Peptides

In Vivo Studies for Peptides

Validated Bioanalytical Platforms for Biomarker Measurement

Our bioanalytical scientists leverage decades of expertise, advanced automation, and high-throughput technologies to deliver robust, reproducible data rapidly. Our team’s experience in assay selection, optimization, and validation provides data you can trust – from nonclinical pharmacodynamic markers to clinical safety and efficacy biomarkers. All methods are developed and validated according to global regulatory standards, including ICH M10 compliance.

WuXi AppTec’s most recent white paper, ICH M10 Guidance: Harmonization and Modification to Bioanalytical Method Validation, outlines the sections that will have the most significant impact on bioanalytical method globally.

    Available Platforms and Technologies:

    • LC-MS/MS: Ideal for small-molecule and peptide biomarkers
    • Ligand Binding Assays (ELISA, MSD, Gyrolab): For cytokines, hormones, and protein biomarkers
    • Simoa (Single Molecule Array): For ultra-sensitive biomarker detection
    • qPCR and RT-PCR: For gene expression and mRNA biomarkers
    • Flow Cytometry: For cell-based markers, immune profiling, and cell therapy applications

    Integrated Services to Support Biomarker Programs:

    • Custom assay development
    • Assay qualification and validation for regulated use
    • Multi-matrix and multi-species support
    • Sample analysis across discovery, IND-enabling, and clinical stages
    • Rapid method transfers and optimization

    Our expertise encompasses emerging therapeutic modalities, including oligonucleotide therapeutics, peptides, antibody-drug conjugates, and other innovative approaches.

    See WuXi AppTec’s current list of validated biomarkers or learn more by downloading our Biomarkers brochure.

    Whether you need a validated method for a known biomarker or a custom solution for a novel target, our bioanalytical experts deliver the data quality you need for confident decision-making.

    Learn more about WuXi AppTec’s bioanalytical services or talk to an expert today.

    Your Global Partner for Bioanalysis

    Need help moving your molecule forward? We can help.