KRIBIOLISA™ Cemiplimab (LIBTAYO) ELISA

SKU: KBI1224 Category:

58,000.00

Enzyme Immunoassay for the estimation of Cemiplimab (LIBTAYO) 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:
Cemiplimab is a fully human monoclonal antibody that works against programmed death receptor-1 (PD-1), which is a negative regulator of T cell function. By blocking PD-1, cemiplimab works to enhance T cell-mediated antitumour responses.Cemiplimab was first approved by the FDA on September 28, 2018, as the first FDA-approved treatment for advanced cutaneous squamous cell carcinoma (CSCC). It was later approved to be used in basal cell carcinoma and non-small non-small cell lung cancer. Cemiplimab was also approved by the European Commission on June 28, 2019. In October 2022, the EMA’s Committee for Medicinal Products for Human Use (CHMP) recommended cemiplimab be granted marketing authorization for the treatment of cervical cancer.

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

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

Immune Checkpoints

Entez Gene ID

REGN-2810 Human

Alternate Names / Synonyms

Cemiplimab, Cemiplimab-rwlc

Alternate Drug Brand Names

Libtayo

Drug Bank Accession Number

DB14707

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