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 .
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.