Description
Introduction:
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 List of Essential Medicines. 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. ADA has been observed in pre-clinical and clinical studies, resulting in significant changes in toxicology, pharmacokinetics and efficacy. These effects result from the generation of drug-induced (neutralizing) autoantibodies against Trastuzumab and can be responsible for allergic reaction, or even anaphylactic shock. This ELISA kit detects Anti-Pembrolizumab antibodies and may be used for monitoring immunogenicity.
Intended Use:
The KRIBIOLISA Anti-Pembrolizumab ELISA is used as an analytical tool for quantitative determination of Anti-Pembrolizumab antibodies in human serum and plasma.
Principle:
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. Absorbance is measured at 450 nm.
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