Analytical Ultracentrifugation for Biopharmaceutical Characterization and Quality Control

Modern biotechnology has rapidly developed, and biotechnological drugs have become the center of global drug research and development as an important aspect of clinical treatment. These drugs have unique advantages, such as strong species specificity and prominent targeting, and they are widely used in the treatment of various intractable diseases. However, their complex molecular structure, poor stability, and significant heterogeneity make quality control much more difficult than that of traditional small-molecule drugs that require high-precision analytical methods. Analytical ultracentrifugation (AUC) technology was pioneered by Theodor Svedberg during the early 20th century, and it has become an indispensable biophysical tool through technological innovation. This technology has unique advantages for the quality control of biotechnological drugs, including non-destructive detection, high resolution, and wide applicability. Therefore, AUC has been extensively adopted for the characterization of various biological products. This review systematically summarizes AUC technology applications in major categories of biotechnological drugs, with the aim to provide technical guidance and promote the standardized application of AUC.