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Three major concerns are associated with drug immunogenicity:
- drug allergenicity or anaphylactic shock
- cross-priming of auto-immune responses
- the ability of anti-drug immune responses to alter pharmacokinetics, pharmacodynamics or other biological activities of the drug
Immunogenicity testing is recommended for biopharmaceuticals by the EMA and FDA .
The „International Conference on Harmonization“ (ICH) adopted guidelines for this testing (see ICH Topic Q6B).
Studies on immunogenicity of therapeutically used peptides, proteins or antibodies are often indispensable in determining bioequivalence – also for generics to determine biosimilarity or biocomparability.
vivo Science provides validated test protocols using rodents to investigate the immunogen- icity of drug candidates or their ingredients.
in vivo studies in rodents
- local lymph node assay
- measurement of DTH responses
- active and passive cutaneous anaphylaxis (GPM, ASA, ACA, PCA)
ex vivo studies in rodents
- Antigen dependent proliferation of primed lymphocytes using 3H-thymidine incorporation
- Antigen dependent cytokine production of primed lymphocytes
- Quantitation of antigen-specific antibodies (ELISA, hemagglutination, additional methods when appropriate)
- Quantitation of antigen/allergen-specific IgE (ELISA)
- Detection of glomerular immune complexes
- Detection of autoantibodies
Please find more information on tests for humoral allergenicity in our anaphylaxis protocols.