Home Journals Articles Updates About
CN
image
收藏切换
Progress in the Application of Process Analytical Technology in the Drug 3D Printing Process
收藏切换
PDF
Ruyue DONG1, 2, Xiaolu HAN1, Zengming WANG1, Kun WAN3, Xiaoxuan HONG1, Hui ZHANG1, Nan LIU1, Mingyuan LI2, *, Aiping ZHENG1, *
Chinese Pharmaceutical Journal | 2025, 60(3) : 214 - 222
Less
收藏切换
Chinese Pharmaceutical Journal | 2025, 60(3): 214-222
Progress in the Application of Process Analytical Technology in the Drug 3D Printing Process
Full
Ruyue DONG1, 2, Xiaolu HAN1, Zengming WANG1, Kun WAN3, Xiaoxuan HONG1, Hui ZHANG1, Nan LIU1, Mingyuan LI2, *, Aiping ZHENG1, *
Affiliations
  • 1 State Key Laboratory of National Security Specially Needed Medicines, Academy of Military Medical Sciences, Beijing, 100850, China
  • 2 College of Biotechnology, Tianjin University of Science and Technology, Tianjin, 300457, China
  • 3 Medical Supplies Center of Chinese PLA General Hospital, Beijing 100089, China
Published: 2025-02-08 doi: 10.11669/cpj.2025.03.002
Outline
收藏切换

With the rapid development of science and technology, the application of 3D printing technology in personalized drug manufacturing is becoming increasingly mature, providing innovative solutions for patients and the pharmaceutical industry. Due to the integration of the 3D printing process, there are more adjustable parameters, and the printing process needs to be analyzed and monitored so as to optimize the printing process and reduce the risk thus to ensure the quality of the product. Process analytical technology (PAT) can ensure the consistency between product quality and intended use through systematic control measures, solving the limitations, contingencies and lags associated with pharmaceutical batch sampling, so the pharmaceutical industry has begun to introduce PAT technology to co-manage the production process. Based on the above background, this paper aims to integrate current research findings, dentify the challenges and opportunities associated with the application of PAT, and provide references for industry practices and future research. This paper briefly introduces PAT-related regulations, model building methods, lists commonly used PAT tools, and summarizes the application of PAT in the process of drug 3D printing. Combined with the advantages of PAT and the current status of domestic and international applications, we also evaluates the current regulatory environment and analyzes the current challenges faced by 3D printed drugs and PAT.

3D printing  /  personalization  /  drug manufacturing  /  process analytical technology
Ruyue DONG, Xiaolu HAN, Zengming WANG, Kun WAN, Xiaoxuan HONG, Hui ZHANG, Nan LIU, Mingyuan LI, Aiping ZHENG. Progress in the Application of Process Analytical Technology in the Drug 3D Printing Process[J]. Chinese Pharmaceutical Journal, 2025 , 60 (3) : 214 -222 . DOI: 10.11669/cpj.2025.03.002
Appendix
Less
Year 2025 volume 60 Issue 3
PDF
150
72
Cite this Article
BibTeX
Article Info
doi: 10.11669/cpj.2025.03.002
  • Receive Date：2024-07-30
  • Online Date：2025-10-29
  • Published：2025-02-08
Article Data
Affiliations
History
  • Received：2024-07-30
Funding
Affiliations
    1 State Key Laboratory of National Security Specially Needed Medicines, Academy of Military Medical Sciences, Beijing, 100850, China
    2 College of Biotechnology, Tianjin University of Science and Technology, Tianjin, 300457, China
    3 Medical Supplies Center of Chinese PLA General Hospital, Beijing 100089, China
References
Share
https://castjournals.cast.org.cn/joweb/zgyxzz/EN/10.11669/cpj.2025.03.002
Share to
QR

Scan QR to access full text

Cite this article
BibTeX
Citations
表12种不同金属材料的力学参数
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
关闭全屏
  • BibTeX
  • EndNote
  • RefWorks
  • TxT
Links
Articles
Latest Articles
Most Read
Collections
Updates
Events
News
Multimedia
About
About Us
Contact
No. 86 Xueyuan South Road, Haidian District, Beijing
100081
010-62199257
qkjq@cast.org.cn

Copyright © 2025 China Association for Science and Technology. All rights reserved. For all open access content, the relevant licensing terms apply.
Sponsored by the Office of the Leading Group for Cybersecurity and Informatization of CAST, and supported by Science and Technology Review Publishing House