Immunogenicity and immunotoxicity are used to evaluate the influence of drug toxicity on the structure and function of the body's immune system and its mechanism of action. Our company has talented, highly trained toxicologists and a comprehensive technology platform focused on safety evaluation services. We provide end-to-end immunogenicity and immunotoxicity evaluation services to ensure that we can respond quickly to all the needs of rare disease research projects.

Introduction to Immunogenicity

Immunogenicity refers to the property of a drug to stimulate the body to form specific antibodies or sensitizing lymphocytes. Factors affecting immunogenicity mainly include molecular size, molecular structure, host, and foreignness, etc. Immunogenicity is a property of the drug itself, and the antibody response it induces can often affect the evaluation of drug toxicity. Mice, rats, guinea pigs, rabbits, and non-human primates are mainly used for immunogenicity evaluation.

Introduction to Immunotoxicity Evaluation

Immunotoxicity evaluation includes immunosuppression, hypersensitivity, adverse immune stimulation, and autoimmunity, which may be related to pharmacological activity. Immunotoxicity evaluation is an important part of studying the effects of drugs or chemical substances on human health, for example, immunosuppression may lead to infection or reduced defense against tumors; immune enhancement may amplify autoimmune reactions or allergic reactions.

Fig.1 Immunotoxicity evaluation in biopharmaceutical development. (Subramanyam, M., et al., 2017)