Description：Enzyme Immunoassay for the Quantitative Determination of Anti-Pembrolizumab in human serum and plasma.
Pembrolizumab, sold under the brand name Keytruda, is a humanized antibody used in cancer immunotherapy that treats melanoma, lung cancer, head and neck cancer, Hodgkin lymphoma, stomach cancer, and cervical cancer.
Pembrolizumab was approved for medical use in the United States in 2014.
In 2017, the US Food and Drug Administration （FDA） approved it for any unresectable or metastatic solid tumor with certain genetic anomalies （mismatch repair deficiency or microsatellite instability）.
It is on the World Health Organization's List of Essential Medicines.
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 sandwich enzyme immunoassay technique.
Pembrolizumab is pre-coated onto microwells.
Samples or standards are pipetted into microwells and antibodies to Pembrolizumab present in the standards or sample are bound by the capture antibody.
Then, a HRP （horseradish peroxidase） conjugated Pembrolizumab is pipetted and incubated.
After washing microwells in order to remove any nonspecific binding, the ready to use substrate solution （TMB） is added to microwells and color develops proportionally to the amount of Anti-Pembrolizumab in the sample.
Color development is then stopped by addition of stop solution.
