| Field | Specification |
|---|---|
| Mfr No | |
| Alternative Names | BB-10901, IMGN901, huN901-DM1, CAS: 1008106-64-6 |
| Assay Type | |
| Cas No. | |
| Detection Method | |
| Detection Range | |
| Product Type | |
| Reactivity | |
| Sample Type(s) | Plasma, Serum |
| Sensitivity | |
| Shipping | |
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Overview
Lorvotuzumab ELISA Kit is an ELISA-based immunoassay designed for quantitative measurement of Lorvotuzumab in research samples. It is commonly used to generate traceable concentration data for biomarker discovery, pathway studies, and comparative analyses across experimental conditions.
Key elements and design rationale
- Assay format: Quantitative Colorimetric ELISA. The format defines how signal scales with analyte abundance and how results are interpreted across a standard curve.
- Working range and sensitivity: dynamic range 0.31-5 μg/mL; analytical sensitivity 0.156 μg/ml. Use these values to plan dilutions and keep readouts within the linear portion of the calibration curve.
- Sample compatibility: Intended for Plasma, Serum matrices. As with most immunoassays, matrix composition can influence apparent signal and should be evaluated with dilution linearity and spike-recovery concepts.
- Recovery reference: Typical recovery is reported as 80-120%. Recovery helps assess whether the sample matrix interferes with detection of spiked analyte.
This kit is supplied for research use in laboratory settings where defined, quantitative readouts are needed for experimental interpretation.
Biological background
Lorvotuzumab mertansine (IMGN901, BB10901, huN901-DM1) is an antibody-drug conjugate (ADC) composed of the cytotoxic maytansinoid derivative, DM1, conjugated to the humanized N901 monoclonal antibody (lorvotuzumab, huN901), which binds CD56 with high affinity. DM1 conjugated to lorvotuzumab via a stable disulfide SPP linker (When DM1 is attached to an antibody with the SPP linker, it is mertansine; when it is attached with the thioether linker, SMCC, it is emtansine). It was developed by ImmunoGen, Inc. Lorvotuzumab mertansine is designed for the treatment of CD56 positive cancers (e.g. small-cell lung cancer, ovarian cancer). It has been granted orphan drug status for Merkel cell carcinoma and has reported encouraging Phase II results for small-cell lung cancer (SCLC). Once bound to CD56 on the surface of the target cell, the conjugate is internalized, the linker is cleaved, DM1 is released which in turn inhibits tubulin polymerization and results in cell death. Maytansine is a natural product, originally derived from the Ethiopian shrub Maytenus serrata. Maytansine inhibits tubulin polymerization, and is approximately 200-1,000 fold more cytotoxic than the Vinca alkaloids. Maytansine is clinically active but its narrow therapeutic window precluded further clinical development. Conjugation to an antibody and intracellular delivery could take advantage of the cytotoxic potency and expand the therapeutic window leading to greater tumor cell death with less overall toxicity. The maytansine derivative DM1 was developed specifically for use in ADCs.
Research relevance and current trends
- Biomarker translation in RUO settings: Increasing use of quantitative immunoassays to stratify experimental cohorts, track longitudinal changes, and benchmark model systems.
- Matrix-aware assay design: Greater emphasis on dilution linearity, spike-recovery, and control concepts to reduce matrix-driven artifacts in serum/plasma and complex lysates.
- Integration with multi-omics: ELISA measurements are often used alongside transcriptomics and proteomics to connect abundance changes with pathway activity and phenotype.
Common research applications
- Comparative quantification: Measure relative changes in analyte levels across treatments, time points, or genotypes to support mechanistic hypotheses.
- Assay development and standardization: Generate reproducible concentration inputs for method qualification, inter-operator comparisons, or bridging studies across platforms.
- Model and sample characterization: Profile baseline and stimulated levels to help interpret immune, endocrine, neurodegenerative, or metabolic phenotypes (as relevant to the target).
Interpretation typically focuses on direction and magnitude of change in the context of controls and sample handling metadata, rather than single-point absolute values.
Notes for experimental interpretation
- Matrix effects: Hemolysis, lipemia, and high protein content can alter background and apparent concentration. Consider consistent collection/processing and evaluate dilution behavior.
- Isoforms and modified forms: Some targets exist as isoforms, fragments, or post-translationally modified species. Ensure the measured form aligns with the biological question and the kit’s intended analyte definition.
- Control concepts: Use negative/blank controls, replicate wells, and—when feasible—orthogonal confirmation (e.g., WB or MS) to strengthen conclusions.
What is this PK ELISA kit designed for?
This pharmacokinetic (PK) ELISA kit is designed to quantitatively measure Lorvotuzumab (CAS No. 1008106-64-6) concentrations in Human biological matrices. It supports PK profiling studies including determination of Cmax, AUC, half-life (t«), clearance, and volume of distribution in preclinical or clinical research settings.
What biological matrices are validated for this assay?
This PK ELISA has been validated for Plasma and Serum. For PK studies, serum or plasma (EDTA or heparin-treated) are the most common matrices. Non-validated matrices (e.g., CSF, urine, tissue lysate) require additional matrix validation before use, including matrix effect assessment and dilutional linearity testing.
What is the quantification range and LLOQ for this kit?
The standard curve (LLOQ?ULOQ) spans 0.31-5 ?g/mL. The lower limit of quantification (LLOQ) is 0.156 ?g/ml. Samples with drug concentrations above the ULOQ should be diluted in drug-free matrix and re-assayed. The LLOQ is defined as the lowest concentration that can be measured with acceptable accuracy (ó20% RE) and precision (ó20% CV).
Does the assay distinguish between free and total Lorvotuzumab?
The assay format (free vs. total Lorvotuzumab measurement) depends on the capture and detection antibodies used. Please refer to the datasheet for information on whether the kit measures free (unbound), total (free + target-bound), or both forms of the drug. This distinction is critical for interpreting PK parameters and receptor occupancy.
Can this kit be used for GLP-regulated bioanalytical studies?
This kit is classified as research use only (RUO). For regulated PK studies submitted to regulatory agencies (FDA, EMA), the bioanalytical method must be fully validated per FDA Guidance (2018 Bioanalytical Method Validation) or EMA equivalent. This kit may be used as a platform for method development prior to GLP validation.
Is there cross-reactivity with endogenous proteins or related drugs?
The selectivity of this assay for Lorvotuzumab over structurally related endogenous proteins or biosimilars depends on the antibody specificity described in the datasheet. Researchers should evaluate cross-reactivity with endogenous analogues (e.g., endogenous hormone counterparts) and co-administered drugs that share structural similarity when designing PK studies.
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