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Pertuzumab Pharmacokinetic ELISA Kit

Pertuzumab Pharmacokinetic ELISA Kit

Figure 1: Pertuzumab ELISA kit standard curve.

Pertuzumab Pharmacokinetic ELISA Kit

The Pertuzumab ELISA kit is a validated tool for whole Pertuzumab and its biosimilar quantification in biological matrices for drug research and development. GenScript’s Pertuzumab Pharmacokinetic ELISA Kit had been comprehensively developed and validated for quantitative measurement of Pertuzumab in cynomolgus monkey serum and plasma, based on the ICH M10 and the FDA bioanalytical method validation guidance for industry
L00978
$498.00

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Overview
Product Description Pertuzumab, marketed under the brand name Perjeta, is a HER2/neu receptor antagonist. It works by preventing the formation of the HER2/HER3 dimer, which in turn blocks signaling by the dimer. Pertuzumab is used in combination with trastuzumab for the treatment of patients with HER2-positive tumors. It is a humanised IgG1 monoclonal antibody produced in mammalian cells.
GenScript’s Pertuzumab Pharmacokinetic ELISA Kit had been comprehensively developed and validated for quantitative measurement of Pertuzumab 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 Pertuzumab ELISA kit is a validated tool for whole Pertuzumab and its biosimilar quantification in biological matrices for drug research and development. 

Product Introduction
LLOQ 6.25 ng/mL
ULOQ 400 ng/mL
Precision Intra-assay: CV≤10%
Inter-assay: CV≤15%
Minimum required dilution (MRD) 1:50, validated non-human primate plasma
Kit Contents
Component Quantity/Size Part No.
Capture Plate 1 plate L1-80
Standard Stock 1 vial (50 μL) L1-10
100×Biotin Anti-Pertuzumab Antibody 1 vial (160 μL) L1-20
Streptavidin-HRP 1 bottle (12 mL) L1-30
Sample Dilution Buffer 1 bottle (60 mL) L1-60
Assay Dilution Buffer 1 bottle (15 mL) L1-90
20×Wash Solution 1 bottle (60 mL) L1-70
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 21 days from the date of opening at 2°C to 8°C.

Assay Principle
Assay Principle Pertuzumab Pharmacokinetic ELISA Kit is a sandwich ELISA assay with a pair of anti-idiotypic monoclonal capture and detection antibodies. When standards or samples are added to the capture plate, the Pertuzumab in the sample can be captured on the plate coated with the Pertuzumab capture antibody. Then the Biotin Anti-Pertuzumab Antibody is added to interact with the Pertuzumab bound on the plate. Streptavidin-HRP (Streptavidin-Horseradish Peroxidase conjugate) is added to interact with the Biotin Anti-Pertuzumab Antibody. After the washing steps, TMB Solution is added, resulting in the formation of blue color. The reaction is stopped by adding Stop Solution. Adding the Stop Solution changes the color 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 Pertuzumab in the sample is precisely quantified against a Pertuzumab 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
  • Pertuzumab Pharmacokinetic ELISA Kit
  • Pertuzumab Pharmacokinetic ELISA Kit

  • Pertuzumab Pharmacokinetic ELISA Kit
  • Pertuzumab Pharmacokinetic ELISA Kit

    Figure 1: Pertuzumab ELISA kit standard curve.


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


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