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Type: Journal article
Title: Challenges and opportunities in the manufacture and expansion of cells for therapy
Author: Maartens, J.
De-Juan-Pardo, E.
Wunner, F.
Simula, A.
Voelcker, N.
Barry, S.
Hutmacher, D.
Citation: Expert Opinion on Biological Therapy, 2017; 17(10):1221-1233
Publisher: Taylor & Francis
Issue Date: 2017
ISSN: 1471-2598
Statement of
Joachim H. Maartens, Elena De-Juan-Pardo, Felix M. Wunner, Antonio Simula, Nicolas H. Voelcker, Simon C. Barry and Dietmar W. Hutmacher
Abstract: Introduction: Laboratory-based ex vivo cell culture methods are largely manual in their manufacturing processes. This makes it extremely difficult to meet regulatory requirements for process validation, quality control and reproducibility. Cell culture concepts with a translational focus need to embrace a more automated approach where cell yields are able to meet the quantitative production demands, the correct cell lineage and phenotype is readily confirmed and reagent usage has been optimized. Areas covered: This article discusses the obstacles inherent in classical laboratory-based methods, their concomitant impact on cost-of-goods and that a technology step change is required to facilitate translation from bed-to-bedside. Expert opinion: While traditional bioreactors have demonstrated limited success where adherent cells are used in combination with microcarriers, further process optimization will be required to find solutions for commercial-scale therapies. New cell culture technologies based on 3D-printed cell culture lattices with favourable surface to volume ratios have the potential to change the paradigm in industry. An integrated Quality-by-Design /System engineering approach will be essential to facilitate the scaled-up translation from proof-of-principle to clinical validation.
Keywords: 3D printed cell culture lattice; cell therapy; cost-of-goods; melt electro-spinning writing; norms; quality-by-design; systems engineering; T cells; translation
Rights: © 2017 Informa UK Limited, trading as Taylor & Francis Group
RMID: 0030073859
DOI: 10.1080/14712598.2017.1360273
Appears in Collections:Paediatrics publications

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