BOC Sciences is responsible for ADC quality research including ADC drug identification, specification, content, purity, safety and quality analysis and method development, validation and testing. Antibody-Drug Conjugates (ADCs) are a new class of biopharmaceuticals made by coupling monoclonal antibodies and small-molecule drugs with strong cytotoxicity through biologically active linkers. The following problems arise during the preparation of commonly used antibody-conjugated drugs:
The heterogeneity of these unconjugated naked antibodies and small molecules with cytotoxicity as well as the coupling drug may affect the efficacy and safety of ADC drugs. Compared with monoclonal antibodies, the production process of ADCs drugs is more complicated. Therefore, in order to ensure the safety and effectiveness of ADCs drugs, the quality of ADCs drugs needs to be monitored. Drug to antibody ratio (hereinafter referred to as DAR) is one of the important parameters for evaluating ADCs drug production process and product quality. Therefore, a comprehensive evaluation of ADC drug structure, DAR, efficacy, and safety is essential before ADC filing. BOC Sciences has a variety of advanced chromatography and mass spectrometry instruments, combined with a professional bioinformatics analysis team, can 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 the analysis and determination of antibody-conjugated drugs. The service project is divided into three modules, which respectively measure the structural characterization, drug effect, and drug impurities of antibody-conjugated drugs, and ensure a comprehensive system analysis and evaluation of ADC structures and drug effects. In the technical report, BOC Sciences will provide you with a detailed technical report, the report includes:
mAb Release and Characterization Testing