LAPSE:2023.2915
Published Article
LAPSE:2023.2915
Design of Experiments for Modeling of Fermentation Process Characterization in Biological Drug Production
Kuang-Lung Hsueh, Tzung-Yi Lin, Meng-Tse (Gabriel) Lee, Ya-Yun Hsiao, Yesong Gu
February 21, 2023
Biological products are increasingly important, and therefore the industry has begun to adopt quality by design, as recommended by the ICH and the U.S. FDA. Smaller companies, however, have faced difficulties in employing full-scale experiments or the quality by design strategy. Thus, this study provides an alternative way to build a model from existing data with experimental software that does not require full-scale experiments. This empirical study hopes to provide a practical way to improve the efficiency of smaller biopharmaceutical companies and researchers. Moreover, the models provided here can be applied to process characterization in recombinant protein production.
Keywords
design of experiments, Modelling, quality by design
Suggested Citation
Hsueh KL, Lin TY, Lee MT(, Hsiao YY, Gu Y. Design of Experiments for Modeling of Fermentation Process Characterization in Biological Drug Production. (2023). LAPSE:2023.2915
Author Affiliations
Hsueh KL: Global Research and Industry Alliance, Tunghai University, Taichung 40704, Taiwan; Department of Animal Science and Biotechnology, Tunghai University, Taichung 40704, Taiwan
Lin TY: Department of R&D, Green AbioTechnology Co., Ltd., Taichung 403306, Taiwan
Lee MT(: Department of Emergency Medicine, National Taiwan University Hospital, Taipei 100, Taiwan
Hsiao YY: Department of Medical Imaging and Radiological Sciences, Chung Shan Medical University, Taichung 40201, Taiwan [ORCID]
Gu Y: Department of Chemical and Materials Engineering, Tunghai University, Taichung 40704, Taiwan
Journal Name
Processes
Volume
10
Issue
2
First Page
237
Year
2022
Publication Date
2022-01-26
Published Version
ISSN
2227-9717
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Original Submission
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PII: pr10020237, Publication Type: Journal Article
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LAPSE:2023.2915
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doi:10.3390/pr10020237
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Feb 21, 2023
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CC BY 4.0
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