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 and by the “International Conference on Harmonization” (ICH Q6B).
Studies on immunogenicity of therapeutic peptides, proteins or antibodies are often needed to determine bioequivalence and for generics to determine biosimilarity or biocomparability.
Using a custom approach we can develop and validate specific sandwich ELISA for measuring total and specific immunoglobulins. We evaluate the assay cut-off point, sensitivity, intra-/inter-assay variability and sample stability.
vivo Science, a Texcell company, provides validated test protocols using rodents to investigate the immunogenicity of drug candidates. Please visit vivo Science, a Texcell company, for more information or for additional tests.