Immunology Services

IITRI provides a wide range of preclinical immunology services including qualification or validation of in vitro immunology assays in the support of GLP studies for FDA submissions. We have expertise with testing of small molecule, biologic, cancer immunotherapy, and gene therapy, and preventative vaccine development programs. We utilize both in vitro and in vivo assays to analyze the immune response of organisms to biologic therapeutics, viral vectors, vaccines, and adjuvants for infectious disease or cancer treatment and prevention.

Immunogenicity

Measuring the ability of a biologic drug or vaccine to elicit an immune response is essential to the preclinical assessment of the biologic’s potential effectiveness (vaccines) or its potential adverse effects (biotherapeutic) in humans. IITRI offers immunogenicity assays for the detection of an immune response against therapeutics or vaccines as part of an in-life study or for in vitro screening of potential vaccines.

• ELISAs: anti-drug antibodies (ADAs), toxicokinetics/pharmacokinetics (TK/PK), or cytokine/biomarker analysis
• Hemagglutination inhibition assays (HAI)
• Viral neutralization assays: view our poster on automated microneutralization focus assays
• Neutralizing antibody assays

Immunophenotyping

The characterization of immune cell populations isolated from peripheral blood, lymphoid organs, or tissues in preclinical animal studies provides insight into the immunotoxicity or Immunomodulatory effects of the drug being evaluated. IITRI offers the following services for immunophenotyping:

• Flow cytometry analysis
• Cell population dynamics and infiltration
• Mucosal immunology
• Cell cycle analysis
• Intracellular cytokine staining (ICS)

Immunotoxicology

Immunotoxicology assays are an essential component of toxicology assessments for potential new medications, according to the ICH/EMA/FDA Guidance S8, “Immunotoxicity Studies for Human Pharmaceuticals.” In addition to the monitoring of standard hematological changes, organ weight alterations, and the occurrence of tumors, IITRI offers the following assays for the additional characterization of immunotoxicology mechanisms.

• Immunophenotyping of cytokines (Luminex, MSD ECL or flow cytometric based arrays)
• Cytokine-secreting cell analysis (ELISpot assay)
• Antibody-Dependent Cell-mediated Cytotoxicity assay (ADCC)
• Cytotoxic T-lymphocyte assay (CTL)
• T-cell exhaustion models
• Murine local lymph node assay
• Lymphocyte blastogenesis / proliferation assay