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GenScript Pertuzumab Pharmacokinetic Elisa Kit; 96 tests
List Price
$498.00
Your Price
$498.00
GenScript Pertuzumab Pharmacokinetic Elisa Kit - GSCRPT (Additional S&H or Hazmat Fees May Apply)
NETA PART:
GSCRPT-L00978
MFG.PART:
L00978
UNSPSC:
41116126
Manufacturer:
GenScript USA Inc
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. |
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 |
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| 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. |
| 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, |
For research use only. Not intended for human and animal therapeutic or diagnostic use.
| SKU | GSCRPT-L00978 |
|---|---|
| Supplier Part Number | L00978 |
| UM | EA |
| UNSPSC | 41116126 |
| Manufacturer | GenScript USA Inc |
| Temperature | 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. |
| ProductLine | GSCRPT |
| Qty | 1 |
| MinOrderQty | 1 |
| Weight | 7.000000 |
| Lead Time | 7 |
| Hazardous | Y |
| Energy Star | No |
| Green | No |
| Controlled | N |