Neutralization Antibody Assays

Neutralization Antibody AssaysWhen an immune response to a therapeutic macromolecule is deemed positive from a immunogenicity assay screening, a cell-based neutralization antibody assay is one approach for the determination of specificity.  This format can specifically detect the presence of anti-drug antibodies (ADAs) that may interfere with the biological activity.

All generated methods for this type of secondary confirmation analysis are performed in close collaboration with the client and can then be validated, all in-line with FDA requirements (GLP, cGMP).  TGA Sciences, Inc. has been performing this service for its clients since 1998 generating various formats that include cell proliferation or some other cell based assay readout or biomarker.