Anti-drug antibody testing: Example results
ADA surrogate assay
In this example, run at Gyros AB, application development labs, Uppsala, Sweden, data was generated from a model system simulating an ADA assay. This is based on mixing biotinylated ‘surrogate’ DM, Alexa-labeled ‘surrogate’ Drug Molecule (DM) and an anti-idiotypic antibody against the ‘surrogate’ DM in a bridging assay format including pre-incubation outside the CD. All antibodies are of mouse origin.
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0.25 µg/ml of biotinylated
‘surrogate’ DM
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0.25 µg/ml Alexa-labeled
‘surrogate’ DM
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0.07 – 300 µg/ml of anti-DM
idiotypic antibody
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In buffer and 10 % mouse
serum, respectively
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Drug tolerance, ADA surrogate assay
In this example, run at Gyros AB, application development labs, Uppsala, Sweden, the same model system has been used to test drug tolerance in the range of 1, 5 and 40 µg/ml of DM.
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0.25 µg/ml of biotinylated
‘surrogate’ DM
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0.25 µg/ml Alexa-labeled
‘surrogate’ DM
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0.07 – 300 µg/ml of anti-DM
idiotypic antibody
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1, 5, 40 µg/ml of unlabeled
DM, respectively
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