Challenges and opportunities in the manufacture and expansion of cells for therapy

Joachim H. Maartens, Elena De-Juan-Pardo, Felix M. Wunner, Antonio Simula, Nicolas H. Voelcker, Simon C. Barry, Dietmar W. Hutmacher

Research output: Contribution to journalReview article

6 Citations (Scopus)

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.

Original languageEnglish
Pages (from-to)1221-1233
Number of pages13
JournalExpert Opinion on Biological Therapy
Volume17
Issue number10
DOIs
Publication statusPublished - 3 Oct 2017
Externally publishedYes

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  • Cite this

    Maartens, J. H., De-Juan-Pardo, E., Wunner, F. M., Simula, A., Voelcker, N. H., Barry, S. C., & Hutmacher, D. W. (2017). Challenges and opportunities in the manufacture and expansion of cells for therapy. Expert Opinion on Biological Therapy, 17(10), 1221-1233. https://doi.org/10.1080/14712598.2017.1360273