Abstract: Antibody drugs, as the fastest-growing biopharmaceuticals, are now widely used in the treatment of autoimmune diseases and turnor. As protein drugs, antibody drugs are inherently unstable and their quality is strictly regulated by regulatory authorities. However, there is limited research on the clinical use of antibody drugs, which may pose potential risks and impact patient safety. This paper summarized the factors that maight affect the quality of antibody drugs during clinical use and briefly introduced the design and concerns of studies related to their usage, providing a reference for research on the clinical application of antibody drugs.