New technologies for the detection of antibodies to therapeutic proteins.

ABSTRACT

The determination of antibody formation in response to a therapeutic product requires that a variety of data be evaluated. In addition to examining immuno-assay and bioassay results, it is important to determine any clinical relevance. By also examining pharmacokinetic data as well as other clinical results, an evaluation can be made as to whether any clinically relevant antibodies were generated. To help in this evaluation, it is important to fully characterize the antibodies that are generated. Both the BIAcore and IGEN platforms are powerful tools for determining if antibodies have been produced in a subject The BIAcore is also able to characterize these antibodies as to isotype, relative concentration, and relative affinity. The bioassay result can identify serum samples that contain an agent capable of inhibiting a biological effect of a drug. When combined with the results of an immuno-assay, it is possible to determine if the antibodies are capable of neutralizing the drug.