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

Pertuzumab Immunogenicity Kit (Bridging ELISA)

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

Pertuzumab Immunogenicity Kit (Bridging ELISA)

Figure 2. MRD analysis of the Kit

Pertuzumab Immunogenicity Kit (Bridging ELISA)

GenScript Pertuzumab Immunogenicity Kit (Bridging ELISA) is designed for detection of anti-Pertuzumab antibody in serum and plasma samples. This kit utilizes a validated bridging immunoassay method based on the FDA, EMA and NMPA Immunogenicity Guidelines
L00979
$498.00

Ask us a question
Overview
Product Description Pertuzumab, marketed under the brand name Perjeta, is a HER2/neu receptor antagonist. It is used in combination with trastuzumab for the treatment of patients with HER2-positive tumors. It is a humanized IgG1 monoclonal antibody produced in mammalian cells.
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. Therefore, it is important to assess the presence and impact of Pertuzumab ADAs on exposure, safety, and efficacy.
GenScript Pertuzumab Immunogenicity Kit (Bridging ELISA) is designed for detection of anti-Pertuzumab antibody in serum and plasma samples. This kit utilizes a validated bridging immunoassay method based on the FDA, EMA and NMPA Immunogenicity Guidelines [1-5]. Through rigorous validation studies, the kit has been demonstrated high sensitivity, specificity, and is free from matrix effects. It is an ideal tool for the analysis of ADA against Pertuzumab. 

Product Introduction
Sensitivity 2.5 ng/mL
Detection Range 1.25-80 ng/mL
Precision Intra-Assay: CV≤10%
Inter-Assay: CV≤15%
Minimum required dilution (MRD) 1:10, validated non-human primate plasma
Hook Effect Not observed at 9,720 ng/mL of anti-Pertuzumab antibodies
Conveniency All reagents and buffers for the test are provided and the test can be completed within 2 hours
Kit Contents
Component Quantity/Size Part No.
Capture Plate 1 plate P1-80
Standard Stock 1 vial (50 μL) P1-10
Biotin Pertuzumab 1 bottle (12 mL) P1-20
Streptavidin-HRP 1 bottle (12 mL) P1-30
Sample Dilution Buffer 1 bottle (60 mL) P1-60
20× Wash Solution 1 bottle (60 mL) P1-70
Stop Solution 1 bottle (6 mL) A1-50
TMB Solution 1 bottle (12 mL) A1-40
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 The GenScript Pertuzumab Immunogenicity ELISA Kit is a bridging immunoassay that utilizes a microplate coated with the Pertuzumab. During the first incubation period, both anti-Pertuzumab antibodies and biotin-conjugated Pertuzumab are added to each well of the plate and then incubated simultaneously. After a washing step, horseradish peroxidase conjugated streptavidin (Streptavidin-HRP) is added and to react with the 3,3',5,5'-Tetramethylbenzidine solution (TMB Solution) 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 Pertuzumab in samples.
Reference 1. Immunogenicity Testing of Therapeutic Protein Products — Developing and Validating Assays for Anti-Drug Antibody Detection.
2. Immunogenicity of Pertuzumab in patients with advanced tumors.
3. Technical Guideline on Immunogenicity of Therapeutic Agents, NMPA, 2021.03.
4. Immunogenicity Testing of Therapeutic Protein Products- Developing and Validating Assays for Anti-Drug Antibody Detection Guidance for Industry, January 2019.
5. Guideline on Immunogenicity assessment of biotechnology-derived therapeutic proteins (EMEA/CHMP/BMWP/14327/2006 Rev 1), 1st Dec 2017.

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

  • Pertuzumab Immunogenicity Kit (Bridging ELISA)
  • Pertuzumab Immunogenicity Kit (Bridging ELISA)

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

  • Pertuzumab Immunogenicity Kit (Bridging ELISA)
  • Pertuzumab 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.


feedback

Do you like the current new website?

Hate

Dislike

Neutral

Like

Love

*