Immunogenicity Assays
Pharmaron offers multiple analytical platforms for immunogenicity assessments to provide robust, reliable results. Understanding how to best characterize immune response is critical throughout the development process with respect to a therapeutics’ safety and efficacy.
As an experienced leader in the field of immunogenicity testing, Pharmaron is experienced in handling the complexities related to immune response which has the potential to affect a product’s pharmacokinetics, pharmacodynamics, safety and efficacy. Whether at a humoral level for Anti-drug 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.
Our Services
Humoral Immune Response
- Development and validation of Anti-drug Antibody (ADA) and Neutralizing Antibody (Nab) assays for preclinical and clinical studies tailored to regulatory needs (GLP, GcLP)
- Utilization of cell-based transduction inhibition and plate-based ligand binding assays for inclusion/exclusion criteria and post-dose monitoring as a safety assessment
- Regulatory and industry-driven strategies for determining cutpoint in populations with pre-existing immunity to a therapeutic
- Adherence to a multi-tiered approach per FDA Guidelines with further ADA characterization for isotyping, epitope specificity, and cross-reactivity
Our Services
Cellular Immune Response
- For viral capsid or/and transgene
- Establishment of Peripheral blood mononuclear cell (PBMC) assays to detect cellular responses against the test agent (e.g. viral capsid and/or transgene), detection of secreted immune molecules or proteins of interest (e.g., interleukins and cytokines)
- Determination of appropriate PBMC preparations for analyzing antigen-specific cells
- Optimized peptide pool concentrations for different assays
Our Services
Immunogenicity Assay Technology Platforms
- Ligand binding assay (ELISA)
- Fluorescence and luminescence-based assays
- ELISpot and FluroSpot
- Meso-scale discovery (MSD)
- Luminex
- Flow cytometry