Biacore T100 in an immunogenicity study: The characterization of antibody responses to a recombinant IgE-derived immunotherapeutic protein. Patterns of changes in the rate constants and affinity constants of the responding antibodies were determined throughout the response period. This “affinity maturation” was shown to be attributable to the changes in both on and off rates of the responding antibody populations.

Four analytical methods for examining antibody-mediated red cell aplasia are compared: Biacore, ELISA, RIP and a biological assay.

A clinical study to evaluate the tolerability, pharmacodynamics and pharmacokinetics of AMG 531, a novel thrombopoietin receptor ligand. Biosensor immunoassays and cell-based bioassays were performed for antibody detections. The study looked for antibodies to AMG 531 and thrombopoietin receptor. No neutralizing antibodies to AMG 531 or antibodies to endogenous thrombopoietin were detected in this study. No binding antibodies to endogenous thrombopoietin were observed. This paper is a good example of the use of Biacore in immunogenicity assays in a clinical study.

This article describes a validated Biacore immunoassay for the detection and characterization of serum antibodies with specificity for erythropoietic molecules (e.g. darbepoetin-a). Traditionally, radioimmune precipitation assays and/or ELISAs are used for the primary detection of host immune responses; however, the Biacore platform may be better suited for this purpose in many instances. Biacore is shown to be a robust tool that should be considered for the detection and characterization of antibodies directed against protein-based therapeutics.

Immunogenicity of an anti-colon cancer antibody in clinical trials. Serum samples were analyzed using Biacore for evidence of the appearance of anti-human antibodies in patients. Serum antibody concentrations were reproducibly and accurately measured using Biacore.

On the detection and isotyping of anti-adenoviral antibodies in patients dosed with an adenoviral-based gene therapy vector (virus integrated with human wildtype pro-apoptotic p53). Whole, intact virus was immobilized onto the sensor surface. Diluted serum and ascitic fluid from patients dosed with vector were analyzed. Results corresponded to an existing ELISA. Reported as easy and rapid.