Description：Enzyme Immunoassay for the quantitative determination of Nivolumab （OPDIVO） in serum, plasma and cell culture supernatant
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Nivolumab is a human IgG4 monoclonal antibody that blocks PD-1.
PD-1 is a protein on the surface of activated T cells.
If another molecule, called programmed cell death 1 ligand 1 or programmed cell death 1 ligand 2 （PD-L1 or PD-L2）, binds to PD-1, the T cell becomes inactive.
This is one way that the body regulates the immune system, to avoid an overreaction.
Many cancer cells make PD-L1, which inhibits T cells from attacking the tumor.
Nivolumab blocks PD-L1 from binding to PD-1, allowing the T cell to work.
PD-L1 is expressed on 40–50％ of melanomas and has limited expression otherwise in most visceral organs with the exception of respiratory epithelium and placental tissue.
Krishgen PK kits, developed using the innovator drug as calibrator, are used for the quantitation of serum protein drug levels, and can be used for biosimilar and generics research as well.
About the kit：
- Uses anti-idiotypic antibodies sourced from our vendor partner in the US, which ensures higher specificity, and low cross reactivity.
- Recovery rates are between 85 - 115％
- Ready to use with a standard protocol with break-apart pre-coated wells
- Validated as per US FDA guidelines for Bioassays
- Optimized for matrix effects to ensure higher sensitivity.
- Shelf life： 1 year
The method employs the quantitative sandwich enzyme immunoassay technique.
Antibodies to Nivolumab are pre-coated onto microwells.
Samples and standards are pipetted into microwells and human Nivolumab present in the sample are bound by the capture antibody.
Then, a HRP （horseradish peroxidase） conjugated anti-Nivolumab antibody is pipetted and incubated.
After washing microwells in order to remove any non-specific binding, the ready to use substrate solution （TMB） is added to microwells and color develops proportionally to the amount of Nivolumab in the sample.
Color development is then stopped by addition of stop solution.
