» Articles » PMID: 35322032

Big Data Collection in Pharmaceutical Manufacturing and Its Use Forproduct Quality Predictions

Overview
Journal Sci Data
Specialty Science
Date 2022 Mar 24
PMID 35322032
Authors
Affiliations
Soon will be listed here.
Abstract

Advances in data science and digitalization are transforming the world, and the pharmaceutical industry is no exception. Multiple sensor-equipped manufacturing processes and laboratory analysis are the main sources of primary data, which have been utilized for the presented dataset of 1005 actual production batches of selected medicine. This dataset includes incoming raw material quality results, compression process time series and final product quality results for the selected product. The data is highly valuable for it provides an insight into every 10 seconds of the process trajectory for 1005 actual production batches along with product quality collected over several years. It therefore offers an opportunity to develop advanced analysis models and procedures which would lead to the omission of current conventional and time consuming laboratory testing. Benefits for both the industry and patient are obvious: reducing product lead times and costs of manufacture.

Citing Articles

The Effect of Formulation Variables on the Manufacturability of Clopidogrel Tablets via Fluidized Hot-Melt Granulation-From the Lab Scale to the Pilot Scale.

Kovacs B, Tokes E, Kelemen E, Zoldi K, Boda F, Suba E Pharmaceutics. 2024; 16(3).

PMID: 38543285 PMC: 10975944. DOI: 10.3390/pharmaceutics16030391.


Big data collection in pharmaceutical manufacturing and its use forproduct quality predictions.

Zagar J, Mihelic J Sci Data. 2022; 9(1):99.

PMID: 35322032 PMC: 8943063. DOI: 10.1038/s41597-022-01203-x.

References
1.
Podczeck F . Methods for the practical determination of the mechanical strength of tablets--from empiricism to science. Int J Pharm. 2012; 436(1-2):214-32. DOI: 10.1016/j.ijpharm.2012.06.059. View

2.
Fisher A, Lee S, Harris D, Buhse L, Kozlowski S, Yu L . Advancing pharmaceutical quality: An overview of science and research in the U.S. FDA's Office of Pharmaceutical Quality. Int J Pharm. 2016; 515(1-2):390-402. DOI: 10.1016/j.ijpharm.2016.10.038. View

3.
Finelli L, Narasimhan V . Leading a Digital Transformation in the Pharmaceutical Industry: Reimagining the Way We Work in Global Drug Development. Clin Pharmacol Ther. 2020; 108(4):756-761. PMC: 7540662. DOI: 10.1002/cpt.1850. View

4.
Rantanen J, Khinast J . The Future of Pharmaceutical Manufacturing Sciences. J Pharm Sci. 2015; 104(11):3612-3638. PMC: 4973848. DOI: 10.1002/jps.24594. View

5.
Markl D, Warman M, Dumarey M, Bergman E, Folestad S, Shi Z . Review of real-time release testing of pharmaceutical tablets: State-of-the art, challenges and future perspective. Int J Pharm. 2020; 582:119353. DOI: 10.1016/j.ijpharm.2020.119353. View