期刊
MOLECULES
卷 27, 期 15, 页码 -出版社
MDPI
DOI: 10.3390/molecules27154846
关键词
data fusion; process analytical technology; chemometrics; process control
资金
- Ministry of Research, Innovation and Digitization, CNCS-UEFISCDI within PNCDI III [PN-III-P1-1.1-PD-2021-0420]
- New National Excellence Program of the Ministry for Innovation and Technology from the National Research, Development and Innovation Fund [UNKP-21-4]
- National Research, Development and Innovation Fund of Hungary, under the 2019-1.3.1-KK funding scheme [2019-1.3.1-KK-2019-00004]
The FDA's guidance on Process Analytical Technology has spurred the pharmaceutical industry to adopt advanced analytical sensors and chemometric tools for improved drug quality. This survey evaluates the challenges and opportunities of implementing data fusion within the PAT concept and discusses its integration with Pharma 4.0.
The release of the FDA's guidance on Process Analytical Technology has motivated and supported the pharmaceutical industry to deliver consistent quality medicine by acquiring a deeper understanding of the product performance and process interplay. The technical opportunities to reach this high-level control have considerably evolved since 2004 due to the development of advanced analytical sensors and chemometric tools. However, their transfer to the highly regulated pharmaceutical sector has been limited. To this respect, data fusion strategies have been extensively applied in different sectors, such as food or chemical, to provide a more robust performance of the analytical platforms. This survey evaluates the challenges and opportunities of implementing data fusion within the PAT concept by identifying transfer opportunities from other sectors. Special attention is given to the data types available from pharmaceutical manufacturing and their compatibility with data fusion strategies. Furthermore, the integration into Pharma 4.0 is discussed.
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