Bioanalytical Method Development & Validation

Validated Bioanalytical Platforms for Biomarker Measurement

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

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.

200+

Small Molecule Validated Bioanalytical Methods

40+

Validated New Methods for Proprietary/Innovator Small Molecules Every Year

150+

Large Molecule Validated Bioanalytical Methods

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 peptides and oligonucleotides, antibody-drug conjugates, and other innovative approaches.

See our 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.