Antibody Drug Conjugates (ADCs) Characterisation and Bioanalysis
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Antibody drug conjugates (ADCs) have received increasing attention in the pharmaceutical industry as new targeted therapies in oncology. The unique target-specific binding of antibody allows targeted delivery of cytotoxic small molecules to cancer cells, and thus expands the therapeutic window. However, in-depth characterization of ADCs is complex because it involves the characterization of antibody, conjugated molecules and antibody conjugates as a whole. An in-depth understanding of the ADC's characteristics is an important assessment in the discovery and development process.
Creative Proteomics provides comprehensive characterization services for ADCs. We use a variety of advanced analytical techniques to conduct comprehensive and detailed analyses from the perspectives of physicochemical properties, immunological properties, biological activity, impurities, and stability. In addition, we also combine the characterization of naked antibodies to fully understand the relevant changes in properties before and after coupling, to provide as much detailed information as possible to reflect the quality attributes of the antibody drug conjugate product, and at the same time, to provide the basis for the establishment of quality standards for ADCs and successful registration.
The Complexity and Role of ADCs Characterization
Heterogeneities of ADCs are contributed by each component (i.e. mAb, linker and cytotoxic payload). Different extents of chemical modifications, clippings, glycosylation, payload distribution in the mAb, the linker fragment and payload metabolism result in high levels of structural complexity. In addition, with the emergence of new ADC drugs, their compositions become more variable and their analysis more complex. Therefore, it is important to select appropriate analytical methods to evaluate and control different ADCs. Comprehensive characterization of ADCs will provide insights into drug distribution, pharmacokinetics and pharmacodynamics, as well as interactions between ADCs and target cells, all of which are critical for rational clinical use and further drug development.
Antibody Drug Conjugates (ADCs) Characterisation and Bioanalysis Services at Creative Proteomics
Creative Proteomics' characterization services are designed to help clients gain a detailed understanding of the key quality attributes, pharmacokinetic properties, impurities, and stability of antibody drug conjugates. We use advanced analytical techniques to assess product integrity and quality to ensure product efficacy and safety.
The analytical characterization services we provide for ADCs include, but are not limited to, the following categories:
Creative Proteomics selects the appropriate analytical method based on the chemistry of the small molecule drug and linker, the mode of coupling, and the complexity of the product to provide a comprehensive analysis of the physicochemical properties of the ADCs.
ADCs are often characterized by large and small molecules, making their bioanalytical process complex. Our bioanalytical experts use ligand binding assays and LC-MS methods to accurately quantify these substances in serum/plasma for PK studies and immunogenicity assessment. Creative Proteomics provides bioanalytical services for ADCs which mainly include:
- Total antibody determination
- Conjugated antibody determination
- Unconjugated antibody determination
- Conjugated payload quantitative analysis
- In vivo DAR characterization
- DAR value determination
- DAR distribution characterization
- Immunogenicity analysis of ADCs
- ADC drug release kinetics study services
We perform comprehensive testing and characterization of ADCs products and process-related impurities through a range of advanced detection techniques, including SDS-PAGE/capillary gel electrophoresis, size-exclusion chromatography and other charge-variant assays.
As a result of linker-drug conjugation to an antibody, not only do the common degradation pathways of antibodies remain, the added moieties bring more degradation pathways and instability. Creative Proteomics conducts a comprehensive study of the physical and chemical stability of ADCs through advanced techniques such as chromatography and electrophoresis, as well as qualitative and quantitative assessment of impurities as appropriate.
Our ADCs Characterization Technologies
We have cutting-edge assays for the comprehensive characterization and bioanalysis of ADCs. Our platform technologies include, but are not limited to, the following:
- High-Performance Liquid Chromatography (HPLC)
- Mass Spectrometry (MS)
- Capillary Electrophoresis (CE)
- Enzyme-linked immunosorbent assay (ELISA)
- Reversed-phase high-performance liquid chromatography (RP-HPLC)
- Hydrophilic Interaction Chromatography (HILIC)
- Ion exchange chromatography (IEX)
- Hydrophobic Interaction Chromatography (HIC)
- Size Exclusion Columns (SEC)
Creative Proteomics' team of experts has a wide range of expertise combined with our state-of-the-art technology for comprehensive ADCs characterization and bioanalytical studies. Contact us to learn more about our service and we will be happy to serve you.
