Quality by Design characterization of the perfusion culture process for recombinant FVIII
- Authors
- Kim, Yong Jae; Paik, Sang Hoon; Han, Sang Kyul; Lee, Sunggeun; Jeong, Yoomin; Kim, Ji-youn; Kim, Chan Wha
- Issue Date
- 5월-2019
- Publisher
- ACADEMIC PRESS LTD- ELSEVIER SCIENCE LTD
- Keywords
- Quality by Design (QbD); Process characterization; Design space; Perfusion culture; Recombinant Factor FVIII
- Citation
- BIOLOGICALS, v.59, pp.37 - 46
- Indexed
- SCIE
SCOPUS
- Journal Title
- BIOLOGICALS
- Volume
- 59
- Start Page
- 37
- End Page
- 46
- URI
- https://scholar.korea.ac.kr/handle/2021.sw.korea/65901
- DOI
- 10.1016/j.biologicals.2019.03.004
- ISSN
- 1045-1056
- Abstract
- A Quality by Design (QbD) concept was applied to characterize a cell culture process for production of the recombinant Factor VIII (rFVIII). We characterized the production bioreactor process and defined the design space by applying risk assessment to determine potential critical process parameters (CPPs) impacting critical quality attributes (CQAs). Characterization studies were subsequently performed using a qualified scaled-down model (SDM) and a multi-factorial design of experiment (DOE) approach to determine both the individual and combined impacts of the potential CPPs on CQAs. Among the operating parameters characterized, production temperature, production pH and a shift in the timing of production affected rFVIII activity and tyrosine sulfation level. Finally, we identified CPPs and established a design space for the cell culture process to identify appropriate conditions for routine manufacturing.
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Collections - College of Life Sciences and Biotechnology > Division of Life Sciences > 1. Journal Articles
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