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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

harvester of beta-scintillation counter for T cell proliferation assaysImmunogenicity 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.