Biomarkers
In the evolving landscape of drug development, biomarkers are critical tools for assessing drug safety, efficacy, and mechanism of action. At WuXi AppTec, we offer comprehensive biomarker method development and validation services to support programs from discovery to preclinical to clinical development.
Accelerate Your Biomarker Strategy with Expert Method Development and Validation
Our scientific and regulatory experts work closely with you to identify relevant biomarkers, develop fit-for-purpose assays, and validate them in accordance with global regulatory guidelines.
Leveraging advanced automation and high-throughput platforms, we rapidly deliver precise biomarker analyses, improving data quality and accelerating timelines. Our expertise encompasses emerging therapeutic modalities, including oligonucleotide therapeutics, peptides, antibody-drug conjugates, and other innovative approaches.
Whether you require exploratory, translational, or fully validated biomarkers, our platform-agnostic approach ensures flexibility and scientific rigor.
Our Services Include:
- Biomarker identification and feasibility assessments
- Custom biomarker assay development using LC-MS/MS, immunoassays (ELISA, MSD, Simoa), qPCR, and flow cytometry
- Fit-for-purpose and full GLP/GCP-compliant bioanalytical validation
- Cross-species and matrix bridging for preclinical to clinical continuity
- Data packages aligned with regulatory expectations
Check out our biomarker-related blogs:
- Application of Protein Biomarkers in Pharmaceutical Research and Bioanalysis Strategies
- Biological Significance and Bioanalytical Strategies of Biomarkers – Complement Detection
- From screening to IND submission: Biomarker analysis in preclinical drug development
- The Crucial Role of Biomarkers in Precision Medicine
- The Essential Role of Biomarkers in Modern Medicine: From Disease Diagnosis to Treatment Optimization
Extensive Biomarker Menu Across Therapeutic Areas
We offer an extensive menu of validated and fit-for-purpose biomarker assays across therapeutic areas, including oncology, immunology, CNS, cardiovascular, and infectious diseases. Our biomarker portfolio covers soluble proteins, enzymes, cytokines, metabolites, and cell-based markers, supporting both exploratory and regulatory-driven programs.
See Our Menu
Small Molecule Preclinical
Large Molecule Preclinical
Small Molecule Clinical
Large Molecule Clinical
If you are unable to find the bioanalytical method you need or require the development of a proprietary assay, please contact us.
We offer a growing library of over 350 validated and qualified biomarkers, many of which are supported by GLP-compliant methods. Custom biomarker assay development is also available to meet your specific scientific and regulatory needs.
Download our Biomarkers brochure, learn more about WuXi AppTec’s bioanalytical services, or talk to an expert today.