Application of process quality engineering techniques to improve the understanding of the in vitro processing of stem cells for therapeutic use

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 wi...

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Main Authors:	Rob Thomas, Paul Hourd, David Williams
Format:	Default Article
Published:	2008
Subjects:	Mechanical engineering not elsewhere classified Cell-based therapy Quality engineering Mesenchymal stem cell Mechanical Engineering not elsewhere classified
Online Access:	https://hdl.handle.net/2134/4265
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id	rr-article-9546956
record_format	Figshare
spelling	rr-article-95469562008-01-01T00:00:00Z Application of process quality engineering techniques to improve the understanding of the in vitro processing of stem cells for therapeutic use Rob Thomas (1249266) Paul Hourd (1250460) David Williams (1248024) Mechanical engineering not elsewhere classified Cell-based therapy Quality engineering Mesenchymal stem cell Mechanical Engineering not elsewhere classified 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. 2008-01-01T00:00:00Z Text Journal contribution 2134/4265 https://figshare.com/articles/journal_contribution/Application_of_process_quality_engineering_techniques_to_improve_the_understanding_of_the_in_vitro_processing_of_stem_cells_for_therapeutic_use/9546956 CC BY-NC-ND 4.0
institution	Loughborough University
collection	Figshare
topic	Mechanical engineering not elsewhere classified Cell-based therapy Quality engineering Mesenchymal stem cell Mechanical Engineering not elsewhere classified
spellingShingle	Mechanical engineering not elsewhere classified Cell-based therapy Quality engineering Mesenchymal stem cell Mechanical Engineering not elsewhere classified Rob Thomas Paul Hourd David Williams Application of process quality engineering techniques to improve the understanding of the in vitro processing of stem cells for therapeutic use
description	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.
format	Default Article
author	Rob Thomas Paul Hourd David Williams
author_facet	Rob Thomas Paul Hourd David Williams
author_sort	Rob Thomas (1249266)
title	Application of process quality engineering techniques to improve the understanding of the in vitro processing of stem cells for therapeutic use
title_short	Application of process quality engineering techniques to improve the understanding of the in vitro processing of stem cells for therapeutic use
title_full	Application of process quality engineering techniques to improve the understanding of the in vitro processing of stem cells for therapeutic use
title_fullStr	Application of process quality engineering techniques to improve the understanding of the in vitro processing of stem cells for therapeutic use
title_full_unstemmed	Application of process quality engineering techniques to improve the understanding of the in vitro processing of stem cells for therapeutic use
title_sort	application of process quality engineering techniques to improve the understanding of the in vitro processing of stem cells for therapeutic use
publishDate	2008
url	https://hdl.handle.net/2134/4265
_version_	1796652872030486528

Application of process quality engineering techniques to improve the understanding of the in vitro processing of stem cells for therapeutic use

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