OBJECTIVE Analyze the key control points and risk points of the process, propose the key points of the review and inspection, based on the continuous encapsulation process of lipid nanoparticles. METHODS On the basis of analyzing the lipid components and coating process of marketed lipid nanoparticles, the similarities and differences in the realization methods, fluid properties, equipment material form, advantages and challenges were analyzed. The key control points, challenge points and risk points, and propose the key technical points of the process were analyzed. RESULTS The challenge and risk points of continuous encapsulation of lipid nanoparticles mainly focus on five aspects: process control model, selection of equipment and hybrid device, application and development of PAT technology, identification and control of disturbance, and disposal of abnormal events. Accordingly, six technical points that should be paid special attention to in the official review and inspection: process research and control strategy, equipment confirmation and plant facilities, process verification and continuous process confirmation, process analysis and control, cleaning verification and cross-pollution prevention and control, and data integrity. CONCLUSION In order to promote the industrialization scale application of new continuous manufacturing technology, review and inspection technical guide is very important. Drug regulatory agency should do more early researches together with the industry.
| 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 |