Antibody-drug conjugate (ADC) is a complex that conjugates cytotoxin to monoclonal antibodies through a constructed linker and selectively delivers cytotoxins to tumors. With rich experience and extensive professional knowledge, BOC Sciences is responsible for ADCs quality research, including ADC drug identification, specification, content, purity, safety and quality analysis, method development, validation, and testing.
Antibody-drug conjugates (ADCs) are a new class of biopharmaceuticals synthesized by conjugating monoclonal antibodies and small-molecule drugs of potent cytotoxicity through biologically active linkers. The heterogeneity of these unconjugated naked antibodies and small molecules as well as the coupling drug may affect the efficacy and safety of ADC drugs overall. Common problems involve in the preparation of antibody-conjugated drugs include: (i) certain antibodies maybe not couple with small-molecule drugs, (ii) multiple binding sites (Cys, Lys residues, etc.) of antibody, and the difference of binding sites and binding amount can lead to heterogeneity, (iii) high hydrophobicity small molecule drugs may lead changes to the overall ADC drug properties.
Based on monoclonal antibody drugs, the conjugation of antibody and small molecule drugs can lead to changes in the physical and chemical properties, such as structure and charge changes. Moreover, different drug-to-antibody ratios (DAR), binding sites and occupancy levels can also bring about a high degree of heterogeneity between ADC drugs. As a result, a higher structurally complex ADC requires more complicated quality control. As a leading service supplier in ADC development, BOC Sciences retains professional technologies and equipment for ADC drugs quantitative analysis to support our customers better screen ADC drugs.
In comparison with monoclonal antibodies, the production process of ADC is much more complicated. Therefore, to ensure the safety and efficiency of ADCs drugs, their quanlity control must be monitored exclusively. Before ADC filing, a comprehensive evaluation of ADC drug structure, drug to antibody ratio (DAR), efficacy, and safety is essential for later development. Thus, BOC Sciences has compliance advanced chromatographies and mass spectrometry instruments operated by our professional bioinformatics analysis team to quickly and accurately provide you with a professional system of antibody-conjugated drug analysis and evaluation services.
BOC Sciences provides a one-stop system for analyzing and determining antibody-conjugated drugs. The bioassays service project is divided into four modules, cellular health assays, drug effects detection, cell detection and non-clinical PK study. BOC Sciences will provide you with a detailed technical report that includes: experimental steps, related MS parameters, original data, and ADCs analysis results.
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