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Pembrolizumab Pharmacokinetic ELISA Kit

Pembrolizumab Pharmacokinetic ELISA Kit

Figure 1: Pembrolizumab ELISA kit standard curve.
A set of Pembrolizumab (PBZ) calibration standards from 160 ng/mL to 2.5 ng/mL was then diluted with Sample Dilution Buffer with a volume ratio of 1:100.

Pembrolizumab Pharmacokinetic ELISA Kit

GenScript’s Pembrolizumab Pharmacokinetic ELISA Kit had been comprehensively developed and validated for quantitative measurement of Pembrolizumab in cynomolgus monkey serum and plasma, based on the ICH M10 and the FDA bioanalytical method validation guidance for industry.
L00968
$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.
GenScript’s Pembrolizumab Pharmacokinetic ELISA Kit had been comprehensively developed and validated for quantitative measurement of Pembrolizumab in cynomolgus monkey serum and plasma, based on the ICH M10 and the FDA bioanalytical method validation guidance for industry. Its precision, accuracy, dilutional linearity, specificity, selectivity, stability, and hook effect were acceptable according to the guidances[1-4]. The Pembrolizumab ELISA kit is a validated tool for whole Pembrolizumab and its biosimilar quantification in biological matrices for drug research and development. The kit can be also used for the detection of single chain variable fragment (scFv) of Pembrolizumab.

Product Introduction
Linearity Range 5 ng/mL-160 ng/mL
Precision Intra-assay: CV≤10%
Inter-assay: CV≤15%
Minimum required dilution (MRD) 1:100 selected by cynomolgus monkey plasma
Specificity No cross-reactivity at 1600 ng/mL of Human IgG4
Hook Effect Not observed at 15000 ng/mL of Pembrolizumab
Kit Contents
Component Quantity/Size Part No.
Capture Plate 1 plate H1-80
Standard Stock 1 vial (50 μL) H1-10
Sample Dilution Buffer 1 bottle (60 mL) E1-90
Biotin Anti-Pembrolizumab Antibody 1 bottle (12 mL) H1-20
Streptavidin-HRP 1 bottle (12 mL) H1-30
TMB Solution 1 bottle (12 mL) A1-40
20× Wash Solution 1 bottle (60 mL) A1-70
Stop Solution 1 bottle (6 mL) A1-50
Plate Sealer 2 pieces 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 Pembrolizumab Pharmacokinetic ELISA Kit is a classic bridging ELISA assay with a pair of anti-idiotypic monoclonal capture and detection antibodies. When standards or samples are added to the capture plate, the Pembrolizumab in the sample can be captured on the plate coated with the Pembrolizumab capture antibody. Then the Biotin Anti-Pembrolizumab Antibody is added to interact with the Pembrolizumab bound on the plate. Streptavidin-HRP (Streptavidin-Horseradish Peroxidase conjugate) is added to interact with the Biotin Anti-Pembrolizumab Antibody. After the washing steps, TMB Solution is added, resulting in the formation of blue color. The reaction is stopped by adding Stop Solution. Application of the Stop Solution results in the color changing from blue to yellow. The intensity of the color can be read at 450 nm and 630 nm by a microplate reader.
The quantity of Pembrolizumab in the sample is precisely quantified against a Pembrolizumab standard curve.
Reference 1, International Council for Harmonisation of TechnicalRequirements for Pharmaceuticals for Human Use. ICH Harmonised Guideline,Bioanalytical Method Validation M10 (2019).
2, US FDA. Bioanalytical Method Validation Guidance for Industry (2018).
3, European Medicines Agency. Guideline on Bioanalytical Method Validation(2011).
4, DeSilva B, Smith W, Weiner R et al. Recommendations for the bioanalyticalmethod validation of ligand-binding assays to support.

Examples
  • Pembrolizumab Pharmacokinetic ELISA Kit
  • Pembrolizumab Pharmacokinetic ELISA Kit

  • Pembrolizumab Pharmacokinetic ELISA Kit
  • Pembrolizumab Pharmacokinetic ELISA Kit

    Figure 1: Pembrolizumab ELISA kit standard curve.
    A set of Pembrolizumab (PBZ) calibration standards from 160 ng/mL to 2.5 ng/mL was then diluted with Sample Dilution Buffer with a volume ratio of 1:100.


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


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