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

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 u...

Full description

Saved in:

Bibliographic Details
Main Authors:	Elizabeth Ratcliffe, Paul Hourd, Juan-Jose Guijarro-Leach, Erin Rayment, David Williams, Rob Thomas
Format:	Default Article
Published:	2013
Subjects:	Mechanical engineering not elsewhere classified Automation Cost of goods Human embryonic stem cell Manufacture Process control Response surface methodology Scalability Mechanical Engineering not elsewhere classified
Online Access:	https://hdl.handle.net/2134/13171
Tags:	Add Tag No Tags, Be the first to tag this record!

id	rr-article-9559988
record_format	Figshare
spelling	rr-article-95599882013-01-01T00:00:00Z Application of response surface methodology to maximize the productivity of scalable automated human embryonic stem cell manufacture Elizabeth Ratcliffe (1250265) Paul Hourd (1250460) Juan-Jose Guijarro-Leach (7200671) Erin Rayment (7129379) David Williams (1248024) Rob Thomas (1249266) Mechanical engineering not elsewhere classified Automation Cost of goods Human embryonic stem cell Manufacture Process control Response surface methodology Scalability Mechanical Engineering not elsewhere classified 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. 2013-01-01T00:00:00Z Text Journal contribution 2134/13171 https://figshare.com/articles/journal_contribution/Application_of_response_surface_methodology_to_maximize_the_productivity_of_scalable_automated_human_embryonic_stem_cell_manufacture/9559988 CC BY-NC-ND 4.0
institution	Loughborough University
collection	Figshare
topic	Mechanical engineering not elsewhere classified Automation Cost of goods Human embryonic stem cell Manufacture Process control Response surface methodology Scalability Mechanical Engineering not elsewhere classified
spellingShingle	Mechanical engineering not elsewhere classified Automation Cost of goods Human embryonic stem cell Manufacture Process control Response surface methodology Scalability Mechanical Engineering not elsewhere classified Elizabeth Ratcliffe Paul Hourd Juan-Jose Guijarro-Leach Erin Rayment David Williams Rob Thomas Application of response surface methodology to maximize the productivity of scalable automated human embryonic stem cell manufacture
description	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.
format	Default Article
author	Elizabeth Ratcliffe Paul Hourd Juan-Jose Guijarro-Leach Erin Rayment David Williams Rob Thomas
author_facet	Elizabeth Ratcliffe Paul Hourd Juan-Jose Guijarro-Leach Erin Rayment David Williams Rob Thomas
author_sort	Elizabeth Ratcliffe (1250265)
title	Application of response surface methodology to maximize the productivity of scalable automated human embryonic stem cell manufacture
title_short	Application of response surface methodology to maximize the productivity of scalable automated human embryonic stem cell manufacture
title_full	Application of response surface methodology to maximize the productivity of scalable automated human embryonic stem cell manufacture
title_fullStr	Application of response surface methodology to maximize the productivity of scalable automated human embryonic stem cell manufacture
title_full_unstemmed	Application of response surface methodology to maximize the productivity of scalable automated human embryonic stem cell manufacture
title_sort	application of response surface methodology to maximize the productivity of scalable automated human embryonic stem cell manufacture
publishDate	2013
url	https://hdl.handle.net/2134/13171
_version_	1797376687571206144

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

Similar Items