目录产品 » Bevacizumab Pharmacokinetic ELISA Kit

Figure 1: Bevacizumab ELISA kit standard curve.
A set of Bevacizumab calibration standards from 39.06 ng/mL to 2500 ng/mL was then diluted with Sample Dilution Buffer with a volume ratio of 1:50.

Bevacizumab Pharmacokinetic ELISA Kit

The Bevacizumab ELISA kit is a validated tool for quantifying both Bevacizumab and its biosimilars in biological matrices, facilitating drug research and development. GenScript’s Bevacizumab Pharmacokinetic ELISA Kit has been comprehensively developed and validated for quantitative measurement of Bevacizumab in cynomolgus monkey serum and plasma, based on the ICH M10 and the FDA bioanalytical method validation guidance for industry.

产品编号	L00969
规格	96 Tests 大单询价
数量
价格	￥4980


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产品概述

Product Description

Bevacizumab, with the brand name Avastin, is a humanized monoclonal antibody of IgG1 isotype. It targets the vascular endothelial growth factor A (VEGF-A), preventing its activation of VEGF receptor and inhibiting malignant cell growth and blood vessel formation. Bevacizumab is approved for the treatment of patients with cervical cancer, metastatic colorectal cancer, primary peritoneal cancer and so on.
GenScript has developed and validated the Bevacizumab Pharmacokinetic ELISA Kit for quantitative measurement of Bevacizumab in cynomolgus monkey serum and plasma, following 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 Bevacizumab ELISA kit is a validated tool for quantifying both Bevacizumab and its biosimilars in biological matrices, facilitating drug research and development.

产品简介

LLOQ

39.06 ng/mL

ULOQ

2500 ng/mL

Precision

Intra-assay: CV≤10%
Inter-assay: CV≤15%

Minimum required dilution (MRD)

1:50 selected by cynomolgus monkey plasma

Specificity

No cross-reactivity at 25,000 ng/mL of Human IgG1

Hook Effect

Not observed at 200,000 ng/mL of Bevacizumab

Kit Contents

Component	Quantity/Size	Part No.
Capture Plate	1 plate	M1-80
Standard Stock	1 vial (50 μL)	M1-10
Sample Dilution Buffer	1 bottle (60 mL)	M1-60
Biotin Anti-Bevacizumab Antibody	1 bottle (12 mL)	M1-20
Streptavidin-HRP	1 bottle (12 mL)	M1-30
20× Wash Solution	1 bottle (60 mL)	M1-70
TMB Solution	1 bottle (12 mL)	A1-40
Stop Solution	1 bottle (6 mL)	A1-50
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.

原理

Assay Principle

Bevacizumab Pharmacokinetic ELISA Kit utilizes a sandwich ELISA assay format with a pair of anti-idiotypic monoclonal antibodies for capture and detection. When standards or samples are added to the capture plate, the Bevacizumab in the sample can be captured on the plate coated with the Bevacizumab capture antibody. The Biotin Anti-Bevacizumab Antibody is then added to interact with the Bevacizumab bound on the plate. Streptavidin-Horseradish Peroxidase conjugate (Streptavidin-HRP) is added to interact with the Biotin Anti-Bevacizumab Antibody. After the washing steps, the addition of 3,3',5,5'-Tetramethylbenzidine solution (TMB Solution) leads to the development of a blue color. The reaction is stopped by adding Stop Solution, causing the color to change from blue to yellow. The intensity of the resulting color can be measured at 450 nm and 630 nm using a microplate reader. The quantity of Bevacizumab in the sample is accurately determined by comparing it against a Bevacizumab standard curve.

Reference

1. International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. ICH HarmonisedGuideline, 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.

图例

Figure 1: Bevacizumab ELISA kit standard curve.
A set of Bevacizumab calibration standards from 39.06 ng/mL to 2500 ng/mL was then diluted with Sample Dilution Buffer with a volume ratio of 1:50.

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