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Published on: February 15, 2019
Immunotoxicity testing in nonhuman primates.
Methods in Molecular Biology (Clifton, N.J.)
|December 8, 2009
Summary
Adapting rodent immunotoxicity testing protocols for nonhuman primates (NHP) is crucial for preclinical safety assessment of biopharmaceuticals and small molecules. These adapted NHP protocols, particularly for cynomolgus monkeys, enhance the detection of specific immunotoxic side effects.
Area of Science:
- Toxicology and Pharmacology
- Immunotoxicology
- Preclinical Safety Assessment
Background:
- Nonhuman primates (NHP) are vital for preclinical safety assessment, especially for biopharmaceuticals and small molecules requiring metabolic similarity or specific immunotoxicity evaluation.
- Standardized immunotoxicity testing protocols are less available for NHP compared to rodents.
- The close physiological similarity between NHP and humans allows for the use of human test kits and reagents.
Purpose of the Study:
- To adapt existing rodent immunotoxicity testing protocols for application to nonhuman primate (NHP) samples.
- To outline methods for assessing immunotoxicity in NHP, focusing on parameters relevant to regulatory guidelines like ICH S8.
- To provide specific guidance for using cynomolgus monkeys and potentially other macaques in immunotoxicity studies.
Main Methods:
- Adaptation of rodent-based immunotoxicity testing protocols for NHP samples.
- Application of most ICH S8 guideline parameters to NHP specimens, with noted exceptions like host resistance and delayed type hypersensitivity assays.
- Development of specific experimental protocols and reagents for cynomolgus monkeys (Macaca fascicularis).
Main Results:
- Established immunotoxicity testing protocols are adaptable for NHP, particularly cynomolgus monkeys.
- Most ICH S8 immunotoxicity parameters are applicable to NHP, facilitating standardized safety assessments.
- Significant inter-animal variability in NHP immunotoxicity assay results is expected due to the absence of inbred strains.
Conclusions:
- Adapted immunotoxicity testing protocols provide a framework for NHP safety assessment, crucial for biopharmaceutical and small molecule development.
- Protocols developed for cynomolgus monkeys are likely applicable to other macaques, expanding their utility in toxicology.
- Understanding and accounting for inter-animal variability is essential for accurate data interpretation in NHP immunotoxicity studies.
