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The regulatory gold standard - TDAR is recommended by FDA, EMA and ICH S8 as the preferred immune function test for immune toxicity assessment.
Comprehensive immune assessment Quantifiable endpoints – KLH-specific IgM and IgG titers; B cell phenotyping (percentage and absolute counts); primary and secondary response kinetics.
IND Ready Data Package – Studies can be conducted according to GLP principles for regulatory submissions.
Representative data from our KLH-induced NHP TDAR model:
KLH-induced NHP TDAR model
• Immunotoxicity assessment of small molecules, biologics, and immunomodulators
• IND supporting studies requiring immune function assessment (ICH S8 compliance)
• Study on the mechanism of action of immunosuppressive or immunostimulating drugs
• Vaccine adjuvant evaluation
• Biomarker discovery of immune competence
scope | Specification |
Species | cynomolgus monkey ( Macaca fascicularis ) |
induction method | Immunization with keyhole limpet hemocyanin (KLH), usually with adjuvant, intramuscular or subcutaneous injection |
study time | 4-8 weeks (evaluation of major and minor reactions) |
critical endpoint | KLH-specific IgM (days 7-14), KLH-specific IgG (days 14-28), B cell phenotyping (percentage and absolute count), optional: T cell subsets, cytokine analysis |
packet | Raw data, analysis reports, flow cytometry files, bioinformatics (optional) |
Q: Why is TDAR considered the gold standard for immunotoxicity assessment?
A: TDAR integrates multiple components of adaptive immunity (antigen presentation, T cell help, B cell activation, antibody production) into a single functional assay. Regulatory guidelines (ICH S8, FDA, EMA) recommend TDAR as the preferred immune function test.
Q: Why use KLH as an antigen?
A: KLH is a highly immunogenic protein that has not been previously exposed in humans or experimental animals, ensuring that the measured antibody response is specific to the immunization and not confounded with pre-existing immunity.
Q: Can this model be used for IND support studies?
Answer: Yes. Studies can be conducted in compliance with GLP principles to support regulatory submissions (FDA, EMA) and meet ICH S8 immunotoxicity testing requirements.
Q: Do you offer customized study protocols (e.g., different adjuvants, timing of immunizations)?
Answer: Of course. Our scientific team customizes immunization plans, adjuvant selection and endpoint analysis based on your specific drug candidate and regulatory requirements.
