| 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. |
| 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 |
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 |
Figure 1: Pertuzumab ELISA kit standard curve.
For research use only.
Not intended for human and animal therapeutic or diagnostic use.
