Any effort aimed at developing antibody drugs must consider the clinical consequences of ADA detection and assessment. The following actions are required for an exhaustive ADA determination:
Screening Assays: competitive, direct, or bridging ELISA
Assay confirmation: determining specificity
Description Assay: identification of isotypes, neutralizing capacity
One potential early indicator of ADA development is IgM ADA.
IgE antibodies against the medication indicate an allergic response.
The biological actions of ADA may benefit from the determination of IgG subclasses. For example, IgG1 and IgG3 in humans are more likely to recognize natural killer (NK) cells and are primarily engaged in complement activation.
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