Immunogenicity Assessment

Immunogenicity testing is critical for evaluating the safety and efficacy of biotherapeutics by assessing immune responses to therapeutic proteins, monoclonal antibodies, and biosimilars. At WaveCyte Bio, we offer comprehensive immunogenicity assessment services to meet regulatory and clinical requirements.

Our Immunogenicity Assessment Services

Anti-Drug Antibody (ADA) Testing: We provide a multi-tiered approach for ADA detection:

• Screening Assays: Identify samples with potential ADA presence.

• Confirmatory Assays: Verify ADA specificity.

• Titer Assays: Quantify the magnitude of the immune response.

Neutralizing Antibody (NAb) Assays: Evaluate the functional impact of antibodies using:

• Cell-Based Assays: Assess inhibition of biological activity.

• Ligand-Binding Assays: Detect NAb interactions with therapeutic targets.

Innate Immune Assays:

• Flow cytometry, ELISA and ELISpot options.

• Cytokine release assay using whole blood or PBMCs

• Monocyte activation assays (MAT)

• Dendritic cell (DC) activation/maturation assays

• Reporter cell line assays

T-Cell Specific Assays:

• T-cell proliferation and Fluorospot assays

• DC/T-cell co-culture assay

What Is Immunogenicity Assessment

Immunogenicity assessment measures the immune response triggered by therapeutic proteins or biologics. This process is vital to:

• Detect anti-drug antibodies (ADA) that may affect drug efficacy or safety.

• Assess the risk of neutralizing antibody (NAb) formation.

• Support regulatory submissions and clinical trial evaluations.

Comprehensive immunogenicity testing to evaluate immune responses elicited by therapeutics. From ELISA-based detection to high-throughput flow cytometry and cytokine release assays, we provide comprehensive data to assess immunogenicity risk. Advance capabilities including T-cell proliferation and Fluorospot assays, enable detailed immune response profiling.

Find out how we can help

Additional Assay Services

PBMC and Immune Cell Isolation, Differentiation and Banking

• Creation and management of various cell banks from donor samples

• Differentiation into specific desired lineages (dendritic cells, macrophages and more)

• Long term cryopreservation and monitoring

Fibroblast Services

• Custom fibroblast cell banking for long-term use

• Differentiation of fibroblasts for specific research applications.

See below for a full list of services

Biological Sample Processing