KRIBIOLISA™ Crovalimab ELISA

SKU: KBI1251 Category:

58,000.00

Enzyme Immunoassay for the estimation of Crovalimab 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:
Crovalimab (SKY59; RO7112689) is a novel humanized antibody against C5 in a pH-dependent manner. Crovalimab binds human FcRn with great affinity, and can block cleavage of C5 by the C5 convertase and inhibite the activity of a C5 variant (p.Arg885His). Crovalimab inhibits C5b-9 formation significantly in all three complement pathways, the classical pathway (CP), lectin pathway (LP), and alternative pathway (AP). Crovalimab has the potential for paroxysmal nocturnal hemoglobinuria (PNH) and complement-mediated diseases research.

Intended Use:
For Estimation of Crovalimab 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 Crovalimab are pre-coated onto microwells. Samples and standards are pipetted into microwells and human Crovalimab present in the sample are bound by the capture antibody. Then, a HRP (horseradish peroxidase) conjugated anti-Crovalimab 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 Crovalimab 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

Species

Human

Biomarker Estimation

measures free drug

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 Crovalimab

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

RG-6107 Human

Alternate Names / Synonyms

Complement c5 inhibitory humanized recycling monoclonal antibody (rg-6107 ), Crovalimab, Immunoglobulin g1, anti-(human complement c5)(humanized ro7112689 heavy chain), disulfide with humanized ro7112689 light chain, dimer

Drug Bank Accession Number

DB16128

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