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The biopharmaceuticals have diverse types, complex sources, low contents, and variable structures. Separation and purification are the core of biopharmaceutical manufacturing. This article first elaborates on the main methods in the purification of biopharmaceuticals and the challenges currently faced. Secondly, it analyzes the limited types of marketed chromatography media and equipment, as well as the low domestication level, which makes it difficult to meet the requirements for efficient biopharmaceuticals manufacturing. It then introduces the key progress made in the development of new−generation chromatography media and efficient separation equipment, including media with uniform−sized media, superporous media, high−capacity media, media with controllable surface properties, mixed−mode media, affinity media, and porous membrane media, as well as continuous flow chromatography, anti−pollution membrane components, reaction and separation coupled systems, and separation and detection coupled systems. It also covers the establishment of relevant quality standards. Finally, it proposes suggestions for the future development of advanced chromatography media and integrated equipment, namely expanding the separation mechanisms, forming an innovative material and equipment cluster, strengthening the multiple synergies between efficient chromatography media and equipment and major and frontier biopharmaceuticals, overcoming core technical difficulties and obstacles in the industrial chain development, highlighting the key points of domestication, greenness, and intelligence in industrialization development.
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| 科 Family | 属数 Number of genus | 种数 Number of species | 占总种数比例 Percentage of total species (%) | 属 Genus | 种数 Number of species | 占总种数比例 Percentage of total species (%) |
|---|---|---|---|---|---|---|
| 鹅膏菌科Amanitaceae | 2 | 11 | 5.26 | 鹅膏菌属 Amanita | 10 | 4.78 |
| 小菇科 Mycenaceae | 2 | 12 | 5.74 | 丝盖伞属 Inocybe | 5 | 2.39 |
| 多孔菌科 Polyporaceae | 8 | 14 | 6.70 | 蜡蘑属 Laccaria | 5 | 2.39 |
| 红菇科 Russulaceae | 3 | 23 | 11.00 | 小皮伞属 Marasmius | 6 | 2.87 |
| 小菇属 Mycena | 11 | 5.26 | ||||
| 光柄菇属 Pluteus | 5 | 2.39 | ||||
| 红菇属 Russula | 17 | 8.13 | ||||
| 栓菌属 Trametes | 5 | 2.39 |
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