| 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. |
| 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 |
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. |
Figure 1: Pertuzumab Immunogenicity Kit (Bridging ELISA) standard curve.
Figure 2. MRD analysis of the Kit
For research use only.
Not intended for human and animal therapeutic or diagnostic use.
