KRIBIOLISA™ Lanadelumab (TAKHZYRO) ELISA

SKU: KBI1413 Category:

58,000.00

Enzyme Immunoassay for the estimation of Lanadelumab in serum and plasma.

About the kit:
– Uses anti-idiotypic monoclonal antibodies which ensures higher specificity, and low cross reactivity.
– Recovery rates are between 85 – 115%
– Validated as per US FDA guidelines for Bioassays
– Precision CV<10%

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



Description

Background:
Lanadelumab, also known as DX-2930, is a human IgG1 monoclonal antibody designed for subcutaneous self-injection.6 It is a fully human immunoglobulin, k-light-chain made in recombinant Chinese Hamster Ovary cells.5 The FDA and EU granted the designation of priority review, breakthrough therapy and orphan drug for rare diseases based on the results of the reported clinical trials.1 Lanadelumab was developed by Shire and FDA approved on August 28, 2018.5

Intended Use:
For Estimation of Lanadelumab (TAKHZYRO) 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.

If you have published a paper by using any of our ELISA since 01/01/2023, kindly fill out the “Krishgen Publication Reward Application Form” with complete information and send it by at email: info@krishgen.com, with the subject “Krishgen Publication Reward”. We will get back to you with the Amazon / Krishgen Credit Reward after we confirm it ASAP!

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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 Lanadelumab

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

DX-2930 Human

Alternate Names / Synonyms

Lanadelumab, Lanadelumab-flyo

Alternate Drug Brand Names

Takhzyro

Drug Bank Accession Number

DB14597

ELISA Type

Direct Sandwich Assay

Storage Temperature

Store the unopened product at 2-8 Deg C. Do not use past expiration date.

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 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