Introduction of Immunotoxicity
Immunotoxicity refers to the damage of exogenous compounds to the immune system. Evaluation of potential adverse effects of human drugs on immune system should be included in standardized drug development. Immune system toxicity includes many adverse reactions. One is immunosuppression, that is, extensive suppression of the immune system, which can increase the susceptibility of the body to infection and the incidence of tumor. The other is immune enhancement, that is, the reactivity of the immune system is excessively enhanced, which may include immune production, allergic reaction (hypersensitivity or allergy), autoimmune reaction and adverse immune stimulation.
If the conventional toxicity study indicates the existence of immunotoxicity, the appropriate additional immunotoxicity test method should be decided according to the nature of the observed immunological changes and the types of compounds. The immune system is very sensitive to exogenous substances, so it is necessary to selectively study some tested substances, especially the poisons whose target organs are the immune system.
Immunotoxicity Studies Provided by Prisys
Generally speaking, immunotoxicity test methods that have been widely used and have proved to be sensitive and specific to known immunosuppressants should be selected. For many drugs, the immunotoxicity of non-human primates is a strongly recommended option. With years of efforts, Prisys developed a world-leading preclinical experiment platform, and completed the immunotoxicity research experiments of hundreds of candidate drugs for many customers around the world. We have an experienced team of over 10 years, which can not only provide suggestions for research design, but also provide extensive in vitro and in vivo immunotoxicological analysis. Include:
1. Conventional toxicity study
Hematology and clinical biochemistry
Gross pathology and organ weight
Histopathological examination
Explanation of stress-related changes
MTD, dose-ranging tests
Single-dose toxicity test
Repeated Dosing Toxicity Test
Allergy test
Hemolytic test
Local irritation test
In vivo phototoxicity test
2. Additional immunotoxicity study.
Test characteristics and test verification
T-cell dependent antibody reaction (TDAR)
Delayed Type hypersensitivity (DTH)
Immunophenotypic analysis
Detection of natural killer cell (NK) activity
Study on host resistance
Macrophage/neutrophil function
Test for measuring cellular immunity
3. Juvenile Animal Study.
Shape differentiation and gender differentiation
Reflection function
Spontaneity
Learning and memory functions
Growth hormone and insulin-like Factor assays
Sperm test
Bone density and bone mass testing
4. Inhalation Study
Routine evaluation test
Mucosal immunity and irritation
Pulmonary function evaluation:
ventilation function
Pathological examination, functional examination
Particle size analysis of inhaled formulations and distribution
5. Animal Species.
Routine test animals
Non-human primates
Miniature pig
Beagle dog
Golden hamster
Immunodeficient mice
Humanized Animal Models
For more information about these models, please contact Mr. James Song, mailto:james.song@prisysbiotech.com
