Infliximab (REMICADE) Neutralizing Antibody ELISA Assay Kit
The Infliximab (REMICADE) Neutralizing Antibody ELISA Assay Kit is For Research Use Only
Size: 12 x 8 wells
Sensitivity: +/-
Incubation Time: 2 hour 20 minutes
Sample Type: Serum, Plasma
Sample Size: 10 µL
Alternative Name: Remicade
Controls Included
Assay Background
“Biological therapeutic proteins can induce the production of anti-drug antibodies (ADA), including neutralizing antibodies (NAb), and consequently result in unwanted immune response in recipients.
NAb can diminish therapeutic efficacy by either preventing the drug from binding to its target or inhibiting downstream signaling upon binding due to steric hindrance. NAb can also cross-react and neutralize the biological activity of an endogenous counterpart in some cases, resulting in the impairment of an essential normal physiological function and life-threatening adverse effects. Therefore, it is essential to monitor the potential NAb during biological drug development. NAb monitoring provides the key information that could allow interpretation of safety studies. Non- neutralizing antibodies (non-NAb) are ADA that bind to sites on the drug molecule that do not affect target binding and thereby do not impact the drug’s pharmacodynamic activity. Non-NAb are often referred to as ‘binding antibodies’, but that is an incorrect term because all types of ADA, are inherently binding antibodies since they bind drug as neutralizing antibodies. Neutralizing antibodies (NAb) are a subset of binding ADA that bind to the drug and inhibit its pharmacological function by preventing target binding. NAbs can inhibit drug activity soon after the drug is administered, but non-NAb do not inhibit the pharmacodynamic activity of the drug.
A neutralizing antibody assay is based on neutralizing antibodies’ drug-target interaction blocking ability. As the concentration of NAb and/or NAb’s binding affinity to drug gets higher, drug-target binding interaction gets lower. In Target Capture Competitive Ligand Binding NAb assays’ design relies on the NAb and target’s competition to bind to the drug between each other. NAb assays are named as direct binding when the presence of NAb can be detected by reduction in signal.
Assay Principle
Target Capture Competitive Ligand Binding NAb assays’ design relies on the NAb and target’s competition to bind to the drug between each other. Controls and samples (serum or plasma) are incubated at room temperature with HRP conjugated infliximab. After l hour incubation the mixture transferred to the plate coated with target ligand protein of the drug. After incubation, the wells are washed, and chromogen-substrate is added to each well. Finally, the reaction is terminated with an acidic stop solution. The inhibition of the color development is proportional to the amount of neutralizing antibodies to infliximab in the sample or controls. The results can be evaluated by using cut-off value.
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