Medica 2026
Nov 16-19, 2026 - Düsseldorf, Germany

Intact DM1 ADC ELISA Quantification Kit

Antibody-drug conjugates (ADCs) have revolutionized cancer therapy by combining the targeting specificity of monoclonal antibodies with the cytotoxic potency of small-molecule drugs. The Intact DM1 ADC ELISA Quantification Kit is a cutting-edge tool designed to precisely measure the concentration of intact DM1-conjugated antibodies in biological samples. This resource page provides detailed technical insights, application guidance, and scientific references to support researchers in leveraging this kit for preclinical and clinical ADC development.

Antibody-drug conjugates (ADCs).Figure 1. Antibody-drug conjugates (ADCs).

Overview of Intact DM1 ADC ELISA Quantification Kit

The Intact DM1 ADC ELISA Quantification Kit is a competitive ELISA-based assay optimized for the quantitative detection of DM1 (mertansine)-conjugated antibodies in serum, plasma, cell culture supernatants, and tissue homogenates. This kit enables accurate measurement of intact ADCs while distinguishing them from free DM1, unconjugated antibodies, or degradation products.

Technology Platform

Sample Type Compatibility

  • Human Serum
  • Human Plasma
  • Animal Matrices (Mouse/Rat/Primate)
  • Cell Culture Supernatants
  • Tissue Homogenates

Sensitivity Profile

  • High Sensitivity (LOD: 0.1–0.5 ng/mL)
  • Matrix Interference-Optimized (validated in serum/plasma)

Kit Features

  • Pre-Coated Microplate (anti-DM1 antibody)
  • Complete Reagent Set (standards, HRP conjugate, buffers, substrate)
  • Automation-Compatible (96-well format for high-throughput)
  • Wide Dynamic Range (0.1–390 ng/mL)

Key Components & Specifications

Key Features

  • Species Compatibility: Validated for human, mouse, rat, and primate samples.
  • High Specificity: Uses monoclonal antibodies targeting both the DM1 payload and the antibody's constant region to ensure detection of intact ADCs only.
  • Wide Dynamic Range: Typically covers 0.1–390 ng/mL, with a sensitivity as low as 0.112 ng/mL (depending on the kit variant).
  • Sample Flexibility: Requires as little as 10 µL of serum or plasma, making it suitable for scarce clinical samples.

Technical Principle

  • The kit employs a competitive ELISA format to quantify intact DM1 ADCs:
  • Coated Plate: Microplate wells are pre-coated with a monoclonal antibody specific to DM1.
  • Sample Incubation: Test samples (e.g., serum) and DM1 ADC calibrators are added to the wells. Intact ADCs in the sample compete with HRP-conjugated DM1 for binding to the immobilized anti-DM1 antibody.
  • Signal Development: After washing, a chromogenic substrate (TMB) is added. The intensity of the color produced is inversely proportional to the concentration of intact DM1 ADCs in the sample.
  • Quantification: A standard curve generated from calibrators allows extrapolation of sample concentrations via spectrophotometric readings at 450 nm.

Understand the kit: principles and components

  • The Intact DM1 ADC ELISA quantitative kit is a sandwich enzyme-linked immunosorbent assay (ELISA). This detection is based on a simple and elegant principle:
  • Capture: The detection plate is pre coated with anti human IgG antibodies. This antibody captures ADC molecules non specifically through its Fc region, effectively immobilizing them on the solid phase.
  • Detection: A key innovation of this kit is the use of biotinylated anti-DM1 antibodies for detection.
  • Signal generation: After detecting antibody binding, add streptavidin HRP (horseradish peroxidase) conjugate. The resulting color intensity is directly proportional to the amount of complete ADC captured on the board.
  • Quantification: Measure the colorimetric signal at 450nm using a standard microplate reader.

Assay Protocol Summary

  • Plate Setup: Add standards, controls, and samples to pre-coated wells.
  • Competitive Binding: Incubate for 1–2 hours at room temperature to allow ADCs and HRP-DM1 to compete for binding.
  • Washing: Remove unbound proteins using a wash buffer to minimize background noise.
  • Substrate Addition: Add TMB and incubate for 15–30 minutes in the dark.
  • Termination & Reading: Stop the reaction with sulfuric acid and measure absorbance at 450 nm.

Applications of the Measles IgG ELISA Kit

Pharmacokinetics (PK) Studies

Pharmacokinetics (PK) Studies

Accurate measurement of the intact ADC in biological fluids (e.g., plasma, serum) is essential for determining its absorption, distribution, metabolism, and excretion (ADME) profile. This kit provides the necessary data to understand the in vivo behavior of the ADC.

Process Development and Quality Control (QC)

Process Development and Quality Control (QC)

During manufacturing, the kit can be used to monitor the intact ADC concentration in various process intermediates and final product formulations. It is a critical tool for assessing product quality and stability.

Intact DM1 ADC ELISA Quantification Kits

ParameterDetails
Product nameDM1 ADC ELISA Kit
SampleSerum, plasma
Intended UseThis highly sensitive "sandwich" test kit is intended for use in the quantitative determination of antibody DM1 conjugate level in human serum or plasma. It is useful for pre-clinical and clinical pharmacology study of DM1 Antibody Drug Conjugate (ADC).
SensitivityThe limit of quantitation(LOQ) was 10ng/mL, the concentration corresponding to the value obtained by test DM1 Antibody Drug Conjugate (ADC) spiked to a low concentration of 10ng/mL under the precision CV<15% and the recovery in the range of 80-120%.
Standard Curve

Advantages of Salmonella Enteritidis ELISA Kit

Robust and Reproducible

Developed under stringent quality control standards, the kit provides consistent and reproducible results, which is critical for generating reliable data for regulatory submissions. The pre-coated plates and validated reagents minimize inter-assay variability.

High Specificity for ADC

The dual-recognition system (anti-IgG capture, anti-DM1 detection) ensures that the assay specifically measures only the fully assembled, drug-loaded ADC. It discriminates against free antibody (unconjugated) and degraded ADCs.

High Sensitivity

The kit is optimized to detect low concentrations of ADC, which is crucial for PK/PD studies and bioanalysis. The wide dynamic range allows for the quantification of samples with varying concentrations without the need for multiple dilutions.

Conclusions

The Intact DM1 ADC ELISA Quantification Kit is an indispensable tool for ADC researchers, offering a robust, validated method to quantify intact DM1-conjugated antibodies in biological samples. By combining high specificity with ease of use, this kit accelerates preclinical and clinical studies, enabling advancements in targeted cancer therapy. For further guidance, refer to the kit's technical manual or contact the manufacturer's support team.

Frequently Asked Questions (FAQ)

Antibody FAQs

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Measuring total antibody (e.g., with a generic anti-human IgG ELISA) only tells you the total concentration of the antibody molecule, regardless of whether it is conjugated to the drug. The Intact DM1 ADC ELISA specifically measures only the antibody molecules that are still attached to the DM1 payload, providing a more accurate measure of the therapeutically active component.

No. The detection antibody in this kit is highly specific to the DM1 payload. A different kit with a different detection antibody would be required for ADCs with other payloads (e.g., MMAE, calicheamicin).

The kit has been validated for use with a variety of biological matrices, including serum, plasma, and cell culture supernatant. For other matrices, a preliminary validation is recommended.

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