KRIBIOLISA™ Certolizumab pegol (CIMZIA) Inhibition ELISA

SKU: KBI1060 Category:

66,000.00

Enzyme Immunoassay for the estimation of Certolizumab pegol (CIMZIA) Inhibition 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%


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



Description

Background:
Certolizumab pegol is a pegylated monoclonal antibody against the tumor necrosis factor-alpha (TNF-alpha). It is formed with a humanized Fab fragment of 50 kDa, from an IgG 1 isotype, fused to a 40 kDa polyethylene glycol moiety replacing the Fc antibody region. The absence of the Fc region was ideated to prevent complement fixation and antibody-mediated cytotoxicity as well as to markedly increase its half-life. Certolizumab does not require glycosylation for active function and hence, its production is significantly more affordable when compared to other existing TNF-alpha therapies as it can be done directly in bacterial hosts such as E. coli. It was developed and manufactured by UCB Pharma, first FDA approved in 200813 and updated for a new indication on March 28, 2019.

Intended Use:
For Estimation of Certolizumab pegol (CIMZIA) Inhibition 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.

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Additional information

Species

Human

Biomarker Estimation

inhibition assay based on competitive principle

Sample Type

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

Calibration Range

0 ng/ml – 640 ng/ml

Sensitivity

Limit of Quantification: 8 ng/ml
Limit Of Detection: 7.75 ng/ml

Detection Method

Colorimetric

Specificity

80% – 120% to Certolizumab pegol (CIMZIA) Inhibition

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

CDP 870 Human

Alternate Names / Synonyms

Certolizumab pegol

Alternate Drug Brand Names

Cimzia

Drug Bank Accession Number

DB08904

ELISA Type

Direct Sandwich Assay

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