生体高分子および生体粒子用クロマトグラフィーの進歩（2019-2024）：材料と産業応用への焦点

Chromatographic technology is the core of downstream separation and purification of biological macromolecules and bioparticles. In recent years, with the emergence of new-generation biotherapeutic modalities such as gene therapy and nucleic acid drugs, chromatographic technology has been undergoing a profound transformation from a general-purpose platform to specialized and intelligent tools. This review systematically summarizes the key advances in this field from 2019 to 2024, mainly organized around two mutually driving themes. First, in terms of materials and design innovation, in response to the separation requirements of complex targets such as antibodies, viral vectors, and nucleic acids, new chromatographic matrices, including porous crystalline materials, smart polymers, and convection-dominated membrane and fiber adsorbents, have been continuously developed. At the same time, artificial intelligence-based rational ligand design is gradually replacing traditional empirical screening, significantly improving separation selectivity and efficiency. Second, in terms of industrial application and process intensification, customized chromatographic purification strategies targeting emerging therapeutic modalities such as mRNA vaccines, adeno-associated viruses, and extracellular vesicles have become a research hotspot. Innovative processes such as continuous chromatography and single-use systems have not only improved production efficiency but also promoted the sustainability of downstream processes. Looking ahead, chromatographic technology will further evolve toward intelligent, platform-based, and green directions, and through the deep integration of data science and materials engineering, consolidate its key position as a core enabling platform in biopharmaceuticals, providing efficient, reliable, and sustainable purification solutions for the development and production of next-generation biologics.