Application of response surface methodology to maximize the productivity of scalable automated human embryonic stem cell manufacture

Article


Ratcliffe, Elizabeth, Hourd, Paul, Guijarro-Leach, Juan, Rayment, Erin, Williams, David J. and Thomas, Robert J.. 2013. "Application of response surface methodology to maximize the productivity of scalable automated human embryonic stem cell manufacture." Regenerative Medicine. 8 (1), pp. 39-48. https://doi.org/10.2217/rme.12.109
Article Title

Application of response surface methodology to maximize the productivity of scalable automated human embryonic stem cell manufacture

ERA Journal ID201443
Article CategoryArticle
AuthorsRatcliffe, Elizabeth (Author), Hourd, Paul (Author), Guijarro-Leach, Juan (Author), Rayment, Erin (Author), Williams, David J. (Author) and Thomas, Robert J. (Author)
Journal TitleRegenerative Medicine
Journal Citation8 (1), pp. 39-48
Number of Pages10
Year2013
Place of PublicationLondon, United Kingdom
ISSN1746-0751
1746-076X
Digital Object Identifier (DOI)https://doi.org/10.2217/rme.12.109
Web Address (URL)https://dspace.lboro.ac.uk/dspace-jspui/bitstream/2134/13171/4/rme.12.109.pdf
Abstract

Aim: Commercial regenerative medicine will require large quantities of clinical-specification human cells. The cost and quality of manufacture is notoriously difficult to control due to highly complex processes with poorly defined tolerances. As a step to overcome this, we aimed to demonstrate the use of 'quality-by-design' tools to define the operating space for economic passage of a scalable human embryonic stem cell production method with minimal cell loss.
Materials & methods: Design of experiments response surface methodology was applied to generate empirical models to predict optimal operating conditions for a unit of manufacture of a previously developed automatable and scalable human embryonic stem cell production method. Results & conclusion: Two models were defined to predict cell yield and cell recovery rate postpassage, in terms of the predictor variables of media volume, cell seeding density, media exchange and length of passage. Predicted operating conditions for maximized productivity were successfully validated. Such 'quality-by-design type approaches to process design and optimization will be essential to reduce the risk of product failure and patient harm, and to build regulatory confidence in cell therapy manufacturing processes.

Keywordsautomation; cost of goods; human embryonic stem cell; manufacture; process control; response surface methodology; scalabilit
ANZSRC Field of Research 2020350715. Quality management
320606. Regenerative medicine (incl. stem cells)
359999. Other commerce, management, tourism and services not elsewhere classified
400302. Biomaterials
Public Notes

© 2013 Future Medicine Ltd. This publication is copyright. It may be reproduced in whole or in part for the purposes of study, research, or review, but is subject to the inclusion of an acknowledgment of the source.

Byline AffiliationsLoughborough University, United Kingdom
Institution of OriginUniversity of Southern Queensland
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