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|Title: ||Application of process quality engineering techniques to improve the understanding of the in vitro processing of stem cells for therapeutic use|
|Authors: ||Thomas, Robert James|
Hourd, Paul C.
Williams, David J.
|Keywords: ||Cell-based therapy|
Mesenchymal stem cell
|Issue Date: ||2008|
|Publisher: ||© Elsevier|
|Citation: ||THOMAS, R.J. ... et al, 2008. Application of process quality engineering techniques to improve the understanding of the in vitro processing of stem cells for therapeutic use. Journal of Biotechnology, 136 (3-4), pp. 148-155|
|Abstract: ||The translation of experimental cell-based therapies to volume produced commercially successful clinical
products requires the development of capable, economic, scaleable (and therefore frequently necessarily
automated) manufacturing processes. Application of proven quality engineering techniques will be
required to interrogate, optimise, and control in vitro cell culture processes to regulatory and clinically
acceptable specifications.We have used a Six Sigma inspired quality engineering approach to design and
conduct a factorial screening experiment to investigate the expansion process of a population of primary
bone marrow-derived human mesenchymal stem cells on a scaleable automated cell culture platform.
Key cell culture process inputs (seeding density, serum concentration, media quantity and incubation
time) and important cell culture process responses (cell number and the expression of alkaline phosphatase,
STRO-1, CD105 and CD71) were identified as experimental variables. The results rank the culture
factors and significant culture factor interactions by the magnitude of their effect on each of the process
responses. This level of information is not available from conventional single factor cell culture studies but
is essential to efficiently identify sources of variation and foci for further process optimisation. Systematic
quality engineering approaches such as those described here will be essential for the design of regulated
cell therapy manufacturing processes because of their focus on identifying the sources of and the control
of variation, an issue that is at the core of current Good Manufacturing Practice.|
|Description: ||This article is Restricted Access. It was published in the Journal of Biotechnology [© Elsevier]. The definitive version is available at: http://www.elsevier.com/wps/find/journaldescription.cws_home/505515/description#description|
|Version: ||Restricted access|
|Appears in Collections:||Closed Access (Mechanical, Electrical and Manufacturing Engineering)|
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