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Immunogenicity Testing Services
Evaluate immune responses to drug candidates, biologics, and other test articles with our in vivo and in vitro immunogenicity testing services. Ichor Life Sciences supports non-GLP discovery research through cytokine profiling, immunoglobulin measurement, cellular assays, and exploratory anti-drug antibody assessment.
Immunogenicity Testing Services for Early-Stage Drug Development
Immunogenicity is the ability of a substance, such as a therapeutic protein, antibody, or other drug candidate, to provoke an immune response. Understanding these responses early in development can help researchers characterize a test article's biological activity and identify potential immune-related liabilities.
Our preclinical immunogenicity testing services combine animal models, blood-based cellular assays, and analytical readouts tailored to the test article, species, and research question. Studies are designed for non-GLP research rather than clinical or regulatory immunogenicity testing.
In Vivo Immunogenicity Testing
Evaluate immune responses following administration of test articles in preclinical animal models, including mice, rats, and rabbits. Depending on the study design, endpoints may include circulating cytokines and immunoglobulin levels.
In Vitro Immune Response Assays
Expose peripheral blood mononuclear cells (PBMCs) or other suitable blood-derived cells to test articles or active pharmaceutical ingredients to investigate cellular immune activation. Available readouts may include flow cytometry and secreted cytokine measurements.
Cytokine Profiling
Measure individual cytokines using targeted assays or evaluate multiple cytokines in parallel through multiplex platforms when compatible with the sample species and assay. Rabbit cytokine analysis may require specialized assay development or individual-analyte approaches.
Immunoglobulin Quantification
Use ELISA-based methods to quantify immunoglobulins, including IgM and IgG, as markers of humoral immune responses. IgM is commonly associated with an early primary response, while IgG often reflects a later or class-switched response.
Exploratory Anti-Drug Antibody Assessment
Investigate whether an animal model develops antibodies that recognize a test article. Study-specific binding assessments may use ELISA, surface plasmon resonance (SPR), or biolayer interferometry (BLI), depending on assay feasibility and reagent availability
Quantitative ELISA Services
Measure soluble analytes such as cytokines, immunoglobulins, proteins, and other study-specific targets with immunoassays developed or selected for the analyte and sample matrix.
Immunogenicity Testing Services: Available Models and Sample Types
In Vivo Models
- Mouse models
- Rat models
- Rabbit models, including test article administration followed by immune-response assessment
In Vitro Sample Sources
- Human blood-derived cells, including PBMCs
- Nonhuman primate blood-derived samples
- Rodent blood-derived samples
- Rabbit blood-derived samples
Featured capability: Rabbit immunogenicity testing services. Ichor can administer test articles to rabbits and evaluate subsequent immune responses using appropriate immunoglobulin and other feasible analytical readouts. Assay availability and sensitivity are confirmed during study planning.