Anti-drug antibody testing
For Anti-drug antibody testing, ELISA, ECL and Imperacer are widely used as platforms of choice. Whereas ELISA is most commonly used for Anti-drug antibody testing throughout the industry, the Imperacer® assay system is the perfect alternative for projects requiring highest drug tolerance.
Drug Tolerance
Imperacer® assays combine greatest sensitivity, excellent precision, highest drug tolerance, and minimal matrix effects. Due to the ultra-sensitivity, Imperacer® is capable of detecting low affinity antibodies already during initial screens in pre-clinical studies. The broad linear range of Imperacer® usually reduces the number of required sample dilutions to one, with no high dose hook effect (“hook effect”) within physiological concentrations.
It has been demonstrated that Imperacer® bridging assay format shows tolerance to the free circulating drug of ratios exceeding 1:1000 just by high dilution of the sample in an appropriate AnySource® buffer. Dissociation of the ADA-drug complex, or even purification of the sample from the free drug, can be fully omitted [1].
Fig. 1: Influence of various amounts of the interfering drug on the sensitivity of an Imperacer® bridging assay for the detection of anti-drug antibody (ADA) [1].
In addition, Imperacer® assays show a very broad detection window in cell-free assays for the evaluation of neutralizing antibodies (Nab). Here, binding of an analyte to its immobilized binding partner (e.g. cell surface receptor) can still be detected even in the presence of more than a 1000-fold excess of Nab [1].
Fig.2: Imperacer® signal intensities in a cell-free neutralizing assay format for the detection of 25 ng/ml labeled drug in the presence of variable amounts of neutralizing ADA/Nab [1].
Following current industry guidelines, we provide assay development and validation as well as bio-analytical services for all phases in the stepwise, risk-based approach to assess the nature and extent of an immunogenic response following the administration of biotherapeutics.
For a web-based presentation of our services or if you have specific questions, pleaseRequest information form our support team.
Literature:
[1] M. Spengler, M. Adler, A. Jonas, C.M. Niemeyer, Immuno-PCR assays for immunogenicity testing, Biochem. Biophys. Res. Commun. 387 (2) (2009) 278-282.
