KRIBIOLISA™ Teclistamab ELISA

SKU: KBI1667 Category:

Enzyme Immunoassay for the estimation of Teclistamab 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%

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:
Teclistamab is a bispecific T-cell engager antibody that targets both B-cell maturation antigen (BCMA) expressed on the surface of myeloma cells and the CD3 receptor expressed on the surface of T cells. The FDA in Oct 2022 granted approval to Janssen Biotech’s Teclistamab (TECVAYLI) for treatment of relapsed or refractory multiple myeloma, marking a new class of therapy now available for patients whose disease had progressed on other types of therapy.

Intended Use:
For Estimation of Teclistamab in human serum and plasma. Krishgen’s range of KRIBIOLISA kits are developed using the high quality raw materials and are thoroughly validated for accuracy and precison. They allow quantification of serum or plasma protein drug levels, and can be used for biosimilar and generics research to understand pharmacokinetic properties of the drug. 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 for optimisation.









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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 @ 450nm

Specificity

80% – 120% to Teclistamab

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

JNJ 64007957 Human

Alternate Drug Brand Names

Tecvayli

Drug Bank Accession Number

DB16655

ELISA Type

Direct Sandwich Assay

Storage Temperature

Store the unopened product at 2-8?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