Catalog Products » Pembrolizumab Immunogenicity Kit (Bridging ELISA)
Pembrolizumab Immunogenicity Kit (Bridging ELISA)

Pembrolizumab Immunogenicity Kit (Bridging ELISA)

Figure 1: Pembrolizumab Immunogenicity Kit (Bridging ELISA) standard curve.

Pembrolizumab Immunogenicity Kit (Bridging ELISA)

Figure 2. MRD analysis of the Kit

Pembrolizumab Immunogenicity Kit (Bridging ELISA)

GenScript Pembrolizumab Immunogenicity Kit (Bridging ELISA) is used for detection of anti-Pembrolizumab antibody in serum and plasma samples. It is a validated bridging immunoassay based on the FDA, EMA and NMPA Immunogenicity Guidelines. The kit has been proved to be highly sensitive, specific, and free from matrix effect in the validation study.
L00971
$498.00

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Overview
Product Description Pembrolizumab, with the brand name Keytruda, is a humanized monoclonal antibody of IgG4 isotype. It targets the programmed cell death protein 1 (PD-1) receptor of lymphocytes, allowing the immune system to destroy cancer cells. Pembrolizumab is an immunotherapy drug. It is used for the treatment of patients with lung cancer, head and neck cancer, and stomach cancer.
Antibody drugs have the possibility to generate anti-drug antibodies (ADAs), which may alter drug clearance and neutralize target binding, causing reduction of drug efficacy. The immunogenicity of antibody drugs may cause anaphylaxis, infusion reactions, and immune complex disorders. Pembrolizumab ADAs and its impact on exposure, safety, and efficacy should be assessed. Analysis of pembrolizumab immunogenicity is generally carried out with a multi-tiered testing approach, which consists of screening tier, confirmation tier, and antibody titer assessment.
GenScript Pembrolizumab Immunogenicity Kit (Bridging ELISA) is used for detection of anti-Pembrolizumab antibody in serum and plasma samples. It is a validated bridging immunoassay based on the FDA, EMA and NMPA Immunogenicity Guidelines[1-5]. The kit has been proved to be highly sensitive, specific, and free from matrix effect in the validation study. It is suitable for the analysis of ADA against Pembrolizumab. 

Product Introduction
Sensitivity 1.56 ng/ml
Detection Range 1.56-50 ng/mL
Precision Intra-assay≤10%
Inter-assay≤15%
Minimum required dilution (MRD) 1:5, validated non-human primate plasma
Conveniency All reagents and buffers for the test are provided and the test can be completed within 2.5 hours
Kit Contents
Component Quantity/Size Part No.
Capture Plate 1 plate K1-80
Standard Stock 1 vial (50 μL) K1-10
100×Biotin Pembrolizumab 1 vial (100 μL) K1-20
Streptavidin-HRP 1 bottle (12 mL) K1-30
Sample Dilution Buffer 1 bottle (60 mL) K1-60
20×Wash Solution 1 bottle (60 mL) K1-70
Stop Solution 1 bottle (6 mL) A1-50
TMB Solution 1 bottle (12 mL) A1-40
Plate Sealer 2 pieces N/A
User Manual 1 piece N/A
Storage The unopened kit is stable for at least 12 months from the date of manufacture at 2°C to 8°C, and the opened kit is stable for up to 1 month from the date of opening at 2°C to 8°C.

Assay Principle
Assay Principle GenScript Pembrolizumab Immunogenicity ELISA Kit is a bridging immunoassay that contains a microplate coated with the pembrolizumab. During the first incubation period, anti-Pembrolizumab antibody and biotin conjugated Pembrolizumab are added to each well of the plate and then incubated at the same time. After a washing step, horseradish peroxidase conjugated streptavidin is added and to react with the TMB substrate to develop a blue product in the solution. The reaction is stopped by adding stop solution, which turns the color yellow and the absorbance can be read at 450 nm by a microplate reader. The intensity of the reaction color is directly proportional to the concentration of antibodies to pembrolizumab in samples.
Reference 1, ImmunogenicityTesting of Therapeutic Protein Products — Developing and Validating Assays forAnti-Drug Antibody Detection.
2, Immunogenicity of pembrolizumab in patients withadvanced tumors.
3, Technical Guideline on Immunogenicityof Therapeutic Agents,NMPA, 2021.03.
4, Immunogenicity Testing of Therapeutic ProteinProducts- Developing and Validating Assays for Anti-Drug Antibody DetectionGuidance for Industry, January 2019.
5, Guide line on Immunogenicity assessment of biotechnology-derivedtherapeutic proteins (EMEA/CHMP/BMWP/14327/2006 Rev 1), 1st Dec 2017.

Examples
  • Pembrolizumab Immunogenicity Kit (Bridging ELISA)
  • Pembrolizumab Immunogenicity Kit (Bridging ELISA)

  • Pembrolizumab Immunogenicity Kit (Bridging ELISA)
  • Pembrolizumab Immunogenicity Kit (Bridging ELISA)

    Figure 1: Pembrolizumab Immunogenicity Kit (Bridging ELISA) standard curve.

  • Pembrolizumab Immunogenicity Kit (Bridging ELISA)
  • Pembrolizumab Immunogenicity Kit (Bridging ELISA)

    Figure 2. MRD analysis of the Kit


For research use only. Not intended for human and animal therapeutic or diagnostic use.


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