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Critical Control and Inspection Points for Continuous Encapsulation of Lipid Nanoparticle
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Xiangyu LI1, Zhe HUANG2, *, Ziyang CAI1
Chinese Pharmaceutical Journal | 2025, 60(10) : 1095 - 1102
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Chinese Pharmaceutical Journal | 2025, 60(10): 1095-1102
Critical Control and Inspection Points for Continuous Encapsulation of Lipid Nanoparticle
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Xiangyu LI1, Zhe HUANG2, *, Ziyang CAI1
Affiliations
  • 1 Shanghai Center for Drug Evaluation and Inspection, Shanghai 200120, China
  • 2 College of Business Administration, Shenyang Pharmaceutical University, Shenyang 110016, China
Published: 2025-05-01 doi: 10.11669/cpj.2025.10.013
Outline
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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.

lipid nanoparticle  /  encapsulation  /  continuous manufacturing  /  drug inspection  /  drug regulatory science
Xiangyu LI, Zhe HUANG, Ziyang CAI. Critical Control and Inspection Points for Continuous Encapsulation of Lipid Nanoparticle[J]. Chinese Pharmaceutical Journal, 2025 , 60 (10) : 1095 -1102 . DOI: 10.11669/cpj.2025.10.013
Year 2025 volume 60 Issue 10
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doi: 10.11669/cpj.2025.10.013
  • Receive Date:2024-04-01
  • Online Date:2025-11-09
  • Published:2025-05-01
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  • Received:2024-04-01
Affiliations
    1 Shanghai Center for Drug Evaluation and Inspection, Shanghai 200120, China
    2 College of Business Administration, Shenyang Pharmaceutical University, Shenyang 110016, China
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表12种不同金属材料的力学参数

Family
属数
Number of
genus
种数
Number of
species
占总种数比例
Percentage of
total species (%)

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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