Expert-led scientific partnership
- Early engagement to define assay strategy
- Fit-for-purpose assay design and validation
- Ongoing scientific and regulatory support
Precision Immunoassays for Global Clinical Development
Drive confident clinical decisions with sensitive, reliable immunoassay testing and expert-led global delivery.
Consistent immunoassay performance across global studies
Immunoassays generate the protein, biomarker, and immune-response data that helps explain how a treatment is behaving in the body. But when assay sensitivity, performance, or delivery varies from site to site, it can create gaps in the data and make results harder to interpret.
For global programs, consistency has to be designed in from the start. That means building an immunoassay strategy around your molecule, study objectives, and the practical realities of running trials across regions and phases.
We support an integrated approach through a focused set of immunoassay services, all delivered under the same quality and scientific standards.
Our capabilities include:
- Ligand-binding assays for protein and biomarker quantification
- Immunogenicity testing, including anti-drug antibody (ADA) and neutralizing antibody (NAb) support
- Pharmacokinetic (PK) and pharmacodynamic (PD) support
- Custom assay development and validation
- Integration with broader biomarker and clinical datasets.
With expert scientific oversight, validated methods, and harmonized delivery across our global lab network, you get consistent, analysis-ready data, so you can see the full picture across your study.
Delivering the expertise your program demands
Advanced immunoassay technologies
- Ligand-binding platforms (MSD, ELISA, ELLA, and more)
- High-sensitivity and high-specificity assay development
- Support for complex biological matrices
Agile and scalable global delivery
- Harmonized laboratory network across regions
- Standardized workflows and validated methods
- Seamless support from early phase to global trials
Integrated biomarker solutions
- Connection between immunoassay, molecular, and cellular data
- Multi-modal data generation across platforms
- Clear, analysis-ready outputs for decision-making
Comprehensive immunoassay capabilities
Ligand-binding assays (LBA)
Develop and execute robust ligand-binding assays to quantify proteins, cytokines, and other biomarkers with high sensitivity and specificity.
Pharmacokinetics (PK) and pharmacodynamics (PD)
Generate precise PK/PD data to assess drug exposure and biological response throughout your study.
Immunogenicity testing (ADA/NAb)
Evaluate ADAs and NAbs to assess immune response and potential impact on safety and efficacy.
Custom assay development and validation
Design, optimize, and validate assays tailored to your specific program, ensuring alignment with study endpoints and regulatory expectations.
Data integration and reporting
Deliver structured, analysis-ready datasets that integrate immunoassay outputs with broader clinical and biomarker data.
Off-the-shelf MSD panel list
Review Cerba Research’s off-the-shelf 37-plex MSD panel, enabling comprehensive, high-sensitivity cytokine and biomarker profiling in a single assay to support disease characterization and safety assessment in complex clinical studies.
Immunoassay insights and resources
Mitigating Immunogenicity Risks in AAV Gene Therapy Clinical Trials
Explore expert perspectives on managing immunogenicity risk, including strategies for assay selection, data interpretation, and minimizing impact on safety and efficacy in biologic drug development.
Prioritizing Safety in CAR-T Therapy: Patient Monitoring with Cerba Research’s Testing Portfolio
Gain insight into FDA expectations for CAR‑T therapies, including analytical strategies, assay validation, and key considerations for supporting regulatory submissions in cell and gene therapy programs.
