Immunotoxicity Evaluation

The discipline of immunotoxicology had its origins in the early 1970s, following the recognition of altered immune function and increased sensitivity to infections and cancers after exposure to environmental chemicals and therapeutic drugs. Therefore, immunotoxicity evaluation is an important part of nonclinical evaluation of oligonucleotide therapeutics. Alfa Chemistry has innovative insights in immunotoxicity evaluation. Please contact us if necessary.

Immune-mediated Adverse Effects

Immunosuppression, immunostimulation, hypersensitivity and autoimmunity are the four types of immune-mediated adverse effects.

Nonclinical evaluation of immunosuppression

Various animal models and assays have been designed, standardized, and validated to evaluate the immunosuppressive effects of oligonucleotide therapeutics in nonclinical studies. Common assays include immune function assays (such as NK-cell activity assays, lymphocyte proliferation assays, delayed-type hypersensitivity assays, etc.), host resistance assays, histological examination of the lymphoid organs, and so on.

Nonclinical evaluation of immunostimulation

Because the clinical consequences of immunostimulation are totally different from those associated with immunosuppression, different host resistance models (such as animal models of experimentally induced autoimmunity, or autoimmunity-prone animals) are generally used to evaluate immunostimulation.

Nonclinical evaluation of hypersensitivity

Guinea-pig contact sensitization tests, for example, the Magnusson and Kligman maximization test or the Buhler test, have long been used in the nonclinical evaluation of hypersensitivity. In addition, the Local Lymph Node Assay (LLNA) in mice is now accepted and increasingly used by regulators. In contrast to guinea-pig tests, where animals are given several sensitizing applications or injections of the test drug followed by topical application after a period of rest, the LLNA mice receive topical applications on one ear and an intravenous injection of tritiated methyl-thymidine to measure lymphocyte proliferation in the draining auricular lymph node.

Nonclinical evaluation of autoimmunity

The popliteal lymph node assay (PLNA) is the only widely studied assay used to evaluate autoimmunity of drugs. By comparing the weight of lymph nodes in treated and control conditions, researchers can infer the immune-stimulatory effects of a drug, guiding further development and safety assessment efforts.

What We Offer?

With experienced experts and state-of-the-art equipment, Alfa Chemistry is able to provide customers with immunotoxicity evaluation services and related technical advice for oligonucleotide therapeutics. We are committed to:

Our products and services are for research use only and cannot be used for any clinical purposes.

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