KRIBIOLISA™ Benralizumab (FASENRA) ELISA

SKU: KBI1183 Category:

58,000.00

Enzyme Immunoassay for the estimation of Benralizumab (FASENRA) in serum and plasma.

Key features:
1. Developed using highly specific monoclonal anti-idiotypic antibodies in a sandwich assay format
2. Validated as per international bioassay validation guidelines
3. Recovery: 80-120%
4. Precision CV <10%


The below Kit Insert is subject to change with the new lot of kits.

Availability: 3 – 4 Weeks | Pack Size: 1 x 96 wells



Description

Background:
Benralizumab is a humanized recombinant monoclonal antibody of the isotype IgG1k immunoglobulin that specifically binds to the alpha chain of the interleukin 5 receptor (IL-5R) expressed on eosinophils and basophils.2 It inhibits the binding of IL-5 as well as the hetero-oligomerization of the alpha and beta subunits of the IL-5R, thus blocking, signal transduction. Besides, it is an afucosylated IgG which gives it high affinity for the FcRIII receptor in natural killer cells, macrophages and neutrophils.1 Benralizumab, FDA approved on November 14, 2017, was developed by MedImmune, the AstraZeneca’s global biologic research and development arm.

Intended Use:
For Estimation of Benralizumab (FASENRA) in human serum and plasma. Please note the kit has not been optimized to be used for any other animal species. Should you require a specific sera tested, please connect with us at sales@krishgen.com for optimization.

Principle:
The method employs the quantitative sandwich enzyme immunoassay technique. Antibodies to Benralizumab are pre-coated onto microwells. Samples and standards are pipetted into microwells and human Benralizumab present in the sample are bound by the capture antibody. Then, a HRP (horseradish peroxidase) conjugated anti-Benralizumab antibody is pipetted and incubated. After washing microwells in order to remove any non-specific binding, the ready to use substrate solution (TMB) is added to microwells and color develops proportionally to the amount of Benralizumab in the sample. Color development is then stopped by addition of stop solution. Absorbance is measured at 450 nm.

Principle:
The method employs the quantitative sandwich enzyme immunoassay technique. Antibodies to Benralizumab are pre-coated onto microwells. Samples and standards are pipetted into microwells and human Benralizumab present in the sample are bound by the capture antibody. Then, a HRP (horseradish peroxidase) conjugated anti-Benralizumab antibody is pipetted and incubated. After washing microwells in order to remove any non-specific binding, the ready to use substrate solution (TMB) is added to microwells and color develops proportionally to the amount of Benralizumab in the sample. Color development is then stopped by addition of stop solution. Absorbance is measured at 450 nm.

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Additional information

Sample Type

Serum (100 ul), EDTA Plasma (100 ul), Heparin Plasma (100 ul), Citrate Plasma (100 ul)

Calibration Range

0 ng/ml – 2000 ng/ml

Detection Method

Colorimetric

Specificity

80% – 120% to Benralizumab (FASENRA)

Cross Reactivity

< 0.5% cross-reactivity observed with related biomarker.

Interference

No significant interference observed with available related molecules.

Regulatory Status

Research Use Only

Research Area

Biosimilars / Therapeutic Drug Monitoring

Entez Gene ID

BIW-8405 Human

Storage Temperature

Store the unopened product at 2-8 Deg C. Opened products to be stored as per temperatures indicated on the datasheet.

Validation

The kit uses a biosimilar research grade standard / calibrator. The standard / calibrator has been validated against WHO/NIBSC standard and/or against commercially sourced innovator drug where available. Please refer to the IFU for more details.

Disclaimer

Trade name indicated is for reference purposes only. It does not reflect any licences or patent usage. The tradename is the registered trademark of the respective owners only.

Long Name

Protein Based Therapies – Monoclonal Antibody