Immunogenicity Services

As an experienced leader in the field of immunogenicity testing, the Pharmaron US team understands the complexities related to immune responses which have the potential to affect a product’s pharmacokinetics, pharmacodynamics, safety and efficacy. Whether at a humoral level for antidrug antibodies (ADA) and neutralizing antibodies (NAb) or looking at cellular immune responses to specific antigens, we can help identify the optimal platform and methodologies to provide high quality reliable results.

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Services

Humoral Immune Response

Anti-drug antibodies – identification and titration of total binding antibodies
Neutralizing antibodies - assessment of ADAs for neutralizing activity
Cell-based transduction inhibition
Plate-based ligand binding
in vivo transduction inhibition

Cellular Immune Response

Peripheral blood mononuclear cell (PBMC) assays to detect cellular responses against the test agent, detection of secreted immune molecules or protein of interest (e.g., interleukins and cytokines)
Quality PBMC preparations for analyzing antigen-specific cells
Optimal concentration of each peptide pool

Multi-Tiered Approach per FDA Guidelines

Screening assay for presence of any ADA
Confirmatory assay to verify positive samples
Titration to determine antibody titer
Neutralizing assay, NAb titers
ADA characterization for isotyping, epitope specificity, cross reactivity

Capabilities

Technology Platforms

Ligand binding assays (ELISA)
Fluorescence- and luminescence-based assays
ELISpot and FluoroSpot
Meso-scale discovery (MSD)
Luminex
Flow cytometry

Learn more about Pharmaron’s expertise by registering for our monthly CGT webinar series, which is focused on identifying key cell and gene therapy questions that arise during drug discovery and development. Register here.

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