Immunogenicity test studies include: antibody titer, time of antibody appearance, number of animals with antibody, dose relationship, dynamic change of antibody titer, neutralizing activity of antibody, change of pharmacodynamics, P, and P toxicity during the same period 1. The activation of complement, the deposition of immune complexes in the liver and kidney, the conditions for termination of administration, analysis of clinical significance, etc.
Immunogenicity refers to the property that drugs stimulate the body to form specific anti- or sensitized lymphocytes. Immunogenicity is the nature of the drug itself. The evaluation of the immunogenicity of biotech drugs is mainly because the antibody response induced by them can often affect the objective evaluation of drug toxicity.
Immunogenicity test antibody detection: It is necessary to establish corresponding methods and investigate methodologies, such as sensitivity and interference of test substances in serum samples. If the neutralizing antibody appears after administration and affects the pharmacological and/or toxic reactions of most animals, the administration can be terminated.
Our Bioanalysis Department can provide analysis of macromolecular drugs in accordance with FDA and NMPA GLP standards to support the selection and development, of small molecule drugs, antibody drugs, vaccines and biomarkers.
Mice, rats, guinea pigs, rabbits, dogs, and non-human primates are mainly used for immunogenic toxicity tests. Specific tests include:
1. Whole body active allergy test (ASA)
2. Whole body passive allergy test (PCA)
3. Skin allergy test (BT)
4. Maximum Test (GMPT)
5. Active skin allergy test (ACA)
6. Skin photosensitivity test
7. Spleen lymphocyte transformation test
8. Choose other relevant tests according to the characteristics of the test substance
| Test type | Animal species | Drug type | Route of administration | research content |
|---|---|---|---|---|
| Immunogenicity | Mice Rat Guinea pig Rabbit Beagles | Small molecule biological Natural products vaccine traditional Chinese medicine | Oral: gavage, capsule Parenteral: intraperitoneal injection, intravenous injection, intramuscular injection, intradermal injection, subcutaneous injection, continuous infusion, intravitreal injection Others: nasal feeding, nasal cavity, eyes, rectum, vagina, implantation | Systemic allergy test Skin allergy test Passive skin allergy test Neutrophil phagocytosis test T, B lymphocyte transformation test NK cell activity test |
Immunotoxicity refers to the immunosuppression or enhancement, allergic reaction or autoimmune reaction caused by the test article, which may be related to pharmacological activity (such as anti-rejection drugs) or not (such as some anti-tumor drugs).
Immunogenicity refers to the nature of drugs that stimulate the body to form specific antibodies or sensitize lymphocytes.
Immunotoxicity refers to the immunosuppression or enhancement, allergic reaction or autoimmune reaction caused by the test article, which may be related to pharmacological activity (such as anti-rejection drugs) or not (such as some anti-tumor drugs). For example, immunosuppression may lead to infection or decrease the defense ability of tumors; immune enhancement may amplify autoimmune reactions or allergic reactions.
Immunotoxicity studies include observation of immunotoxicity indicators in routine toxicity tests and additional immunotoxicity tests:
1. Conventional immunotoxicity indicators include: total number of white blood cells and their classification counts, globulin and white P ball ratio, gross anatomy of lymphoid organ P tissues, organ weight and histological examination of thymus and spleen (thymus, spleen, drainage lymph nodes and One lymph node, bone marrow, Peyerps node, BALT, NALT) in other parts.
2. Additional immunotoxicity test: from the literature report, the structure of the test product and the routine immunotoxicity index test results suggest that there is immunotoxicity, additional immunotoxicity test should be conducted. Some additional immunotoxicity tests can be incorporated into routine toxicity tests, and only the conventional toxicity test protocol needs to be modified, such as adding satellite groups, increasing immunological indicators, or changing the dosing protocol. In addition, after the immunosuppressive effect is found in adult animals, it is necessary to evaluate the immunotoxicity of development, such as observing the changes in the lymphatic system and blood system of the offspring after the mother is exposed to the drug. Additional immunotoxicity tests include immune function tests (e.g. T cell dependent antibody response, NK cell activity, CTL activity, cytokine expression, macrophage P neutrophil function, skin hypersensitivity, host resistance studies) and Immunophenotype detection. The choice of test items depends on the action characteristics and indications of the tested drugs.
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The above is related to the immunogenicity test and immunogenicity test, which is from the official website of Medicilon.
Factors Affecting the Immunogenicity of Biological Drugs
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