Introduction:
Daratumumab (trade name Darzalex) is an anti-cancer drug. It binds to CD38, which multiple myeloma cells overexpress. Daratumumab was originally developed by Genmab, but it is now being jointly developed by Genmab along with the Johnson & Johnson subsidiary Janssen Biotech, which acquired worldwide commercialization rights to the drug from Genmab. Daratumumab was given breakthrough therapy drug status in 2013 for multiple myeloma. It was awarded orphan drug status for multiple myeloma, diffuse large B cell lymphoma, follicular lymphoma, and mantle cell lymphoma. 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 Daratumumab and can be responsible for allergic reaction, or even anaphylactic shock. This ELISA kit detects Anti-Daratumumab antibodies and may be used for monitoring immunogenicity.
Intended Use:
The KRIBIOLISA Anti-Daratumumab (Darzalex) ELISA is used as an analytical tool for quantitative determination of Anti-Daratumumab antibodies in serum, plasma and cell culture supernatant.
Principle:
The method employs the quantitative sandwich enzyme immunoassay technique. Daratumumab is pre-coated onto microwells. Samples and standards are pipetted into microwells and antibodies to Daratumumab present in the sample are bound by the capture antibody. Then, a HRP (horseradish peroxidase) conjugated Daratumumab 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-Daratumumab in the sample. Color development is then stopped by addition of stop solution. Absorbance is measured at 450 nm.
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