KRIBIOLISA Denintuzumab Mafodotin ELISA

KRIBIOLISA Denintuzumab Mafodotin ELISA

SKU: KBI1260

Rs 105,000.00

Enzyme Immunoassay for the estimation of Denintuzumab Mafodotin 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

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Background:
Denintuzumab (hBU 12) is a recombinant humanized anti-CD19 monoclonal antibody. Denintuzumab can be used as the antibody moiety (ADC antibody) of antibody-drug conjugates to synthesize ADC, Denintuzumab Mafodotin (SGN-CD19A). Denintuzumab Mafodotin can be used in the research of acute lymphoblastic leukemia.

Intended Use:
For Estimation of Denintuzumab Mafodotin 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.

Additional information

Target / Pathway

Therapeutic target / pathway (unspecified)
Active Molecule / Modality

Biologic Drug / Protein
Pack Type

1 x 96 wells, break-apart
Species Reactivity

Homo Sapiens (Human)
Sample Type

Serum, plasma, tissue homogenates, cell lysates, cell culture supernates and other biological fluids. For tear samples, please connect with us to discuss further. Note the kit has been validated using human matrices only. For any other animal matrix, pleas connect with us to optimize the kit accordingly.
Analyte / Drug

Denintuzumab
Species / Population Reported for Cmax Value

not available
Dose & Regimen Reported

not available
Cmax (value + units)

Not reported in label/PI
Cmax Source (DOI/URL), where available

not available
Sample Dilution

Samples are to be diluted 1:1000 with the Sample Diluent provided in the kit. For more specific dilution instructions, please refer to the most updated IFU enclosed with the kit supplied
Assay Range Correlated with Cmax Value, where available

0 – 2000 ng/ml
Standards Available

0; 31.25; 62.5; 125; 250; 500; 1000; 2000 ng/ml
Calibration Curve

6/8 point; standards available
Sensitivity

15 ng/ml
Interference

Preparations of the known factors were assayed for interference. No significant interference was observed.
Specificity

The assay uses anti idiotypic (humanized) antibody for capture and / or recombinant protein expressed in mamalian cells, The standards used are research grade biosimilars referenced to the innovator product. In specfic cases where vailable the kit has also been validated against the innovator / reference product. Refer our detailed validation guide for the same.
Detection Method

Colorimetric, Absorbance measured at 450nm
Conjugate-Enzyme Reaction

Uses stable HRP Enzyme Conjugate with (single component) TMB Chromogenic Substrate for color development.
Shipping Temperature

Shipped at Room Temperature or in gel pack to maintain temperature at 2-8 degrees Celsius
Storage Temperature

The kit (2-8 Degree Celsius) and its components are to be stored as indicated in the IFU (instructions for use). To ensure quality of your results, if all the wells in the kit are not being used, store the unused wells in the foil pouch containing the desiccant pack, well sealed and store at the indicated temperature. Similary aliquot and store the reconstituted standard at -20 Degree Celsius for long term storage (maximum 6 months from reconstitution) and to avoid deterioration in the activity.
ELISA Type

Sandwich ELISA, Double Antibody
ELISA Interpretation

Quantitative Results Intepretation, 4PL (2nd order) or Cubic Spline Graph. Software (MS Excel) available, on request, to support interpretation of results.
Shelf Life Available

8 -10 months at time of shipping
Alternate Names / Synonyms

Denintuzumab Mafodotin
Research Area

Immune Molecule; Cell Biology; Immunology, Tumor
SKU: KBI1260 Category: Tag:

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