ADC Characterization Service

Integrated physicochemical, structural, and bioactivity assays quantify drug-to-antibody ratio, conjugation sites, stability, and controlled payload release for each conjugate. Alfa Cytology equips projects with mass-spectrometry, chromatographic, and cell-based analytics under a single roof, providing complete ADC characterization support from sample receipt to data interpretation.

Introduction to Characterization of ADC

Comprehensive characterization of antibody–drug conjugates (ADCs) provides the data foundation that links molecular design to downstream performance. By integrating physicochemical profiling, structural verification, and mode-of-action confirmation, it quantifies key quality attributes such as drug-to-antibody ratio, conjugation homogeneity, stability, and payload release kinetics. These metrics are correlated with in vitro potency, pharmacokinetic behavior, and safety margins, enabling informed progression of candidates.

Fig 1. Summary of tools for in vitro and in vivo characterization of ADCs. (LIU T, et al., 2022)

Significance of Comprehensive ADC Characterization

Our Services

Alfa Cytology delivers comprehensive characterization packages that disclose each antibody–drug conjugate's structural integrity, payload distribution, and solution behavior. These insights streamline candidate selection and guide subsequent optimization across early development stages.

Drug-to-Antibody Ratio (DAR) Determination Quantifies the average number of payload molecules per antibody using orthogonal chromatographic and mass-spectrometric readouts, establishing a key linkage between conjugation chemistry and biological performance.

Conjugation-Site Mapping Locates and ranks payload attachment residues through peptide-level LC-MS/MS, validating that conjugation occurs at intended positions and remains consistent across batches.

Stability & Forced-Degradation Profiling Subjects ADCs to thermal, pH, oxidative, and mechanical stress, then monitors chemical and physical changes to project shelf life and guide formulation strategies.

Payload Release Kinetics Measures linker cleavage rates under intracellular-mimicking conditions to confirm controlled liberation of the cytotoxic payload while maintaining systemic stability.

Antigen-Binding Affinity Verification Confirms that conjugation preserves target recognition by comparing kinetic parameters (KD, kon, koff) with those of the naked antibody.

Serum Compatibility & Off-Target Interaction Screening Tracks conjugate integrity and non-specific binding in biologically relevant matrices, helping predict in vivo exposure profiles and minimize unwanted interactions

In Vitro Potency Correlation Relates structural attributes (DAR, aggregation, linker stability) to cytotoxic effects across target-expressing cell lines, providing an early gauge of therapeutic window.

More Alfa Cytology also provides a comprehensive suite of analytical services to fully determine the critical quality attributes of your Antibody-Drug Conjugate (ADC).

Alfa Cytology applies advanced protein chemistry insight to deliver data-rich profiles covering drug-to-antibody ratio, conjugation homogeneity, and stability for antibody–drug conjugates. If you have any questions or would like to discuss an ADC characterization requirement, please feel free to contact us.

Reference

1. LIU T, TAO Y, XIA X, et al. Analytical tools for antibody–drug conjugates: From in vitro to in vivo [J]. TrAC Trends in Analytical Chemistry, 2022, 152: 116621.

For research use only, not for clinical use.