IITRI provides a wide range of preclinical in vitro immunology assays to support preclinical studies for small molecule, biologic, and gene therapy treatments, and vaccine development programs from discovery through analysis of human clinical trial samples. We utilize both in vitro and in vivo assays to analyze the immune response of organisms to biologic therapeutics and to infectious disease antiviral or antibacterial drugs, vaccines, and adjuvants.
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) or cytokines
- Hemagglutination inhibition assays (HAI)
- Viral neutralization assays: view our poster on automated microneutralization focus assays
- Neutralizing antibody assays
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 (FACS)
- Cell population dynamics and infiltration
- Mucosal immunology
- Cell cycle analysis
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 cytokine 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
The IITRI Advantage
- Highly skilled and experienced scientific team with over 50% of the scientists holding advanced degrees
- Extensive experience in evaluating the immune response of vaccines and antivirals
- Expertise in GLP and GMP compliant ELISA method development and validation
- Personalized program design for non-standard and customized studies