KRISHGEN BIOSYSTEMS Immunoassay for the Quantitative Determination of Anti-Eculizumab antibodies in human serum and plasma. Assay Range: 20 - 640 ng/ml; Sensitivity: 18 ng/ml.

Supplier:  KRISHGEN BIOSYSTEMS KBI2024

Pack Size: 1 x 96 wells. This ELISA kit detects Anti-Eculizumab antibodies and may be used for monitoring immunogenicity. Introduction: Eculizumab, sold under the trade name Soliris, is a medication used to treat paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS). It is a humanized monoclonal antibody functioning as a terminal complement inhibitor. In people with PNH, it reduces both the destruction of red blood cells and need for blood transfusion, but does not appear to affect the risk of death. Eculizumab was the first drug approved for each of its uses, and its approval was granted on the basis of small clinical trials. Anti-Drug Antibodies (ADA) may induce unwanted side effects in biopharmaceuticals. Hence, ADA has been subjected to increase in scrutiny by the regulatory authorities using immunogenicity safety studies. ELISA Features include a pre-coated plate with break-apart wells, standardisation and Precision CV <10%.

Catalog No. NC2747150