Industrialization of a perfusion bioreactor: Prime example of a non-straightforward process

G Talò, C Turrisi, C Arrigoni, C Recordati, I Gerges, M Tamplenizza, A Cappelluti, S A Riboldi, M Moretti

Research output: Contribution to journalArticle

3 Citations (Scopus)

Abstract

Bioreactors are essential enabling technologies for the translation of advanced therapies medicinal products from the research field towards a successful clinical application. In order to speed up the translation and the spread of novel tissue engineering products into the clinical routine, tissue engineering bioreactors should evolve from laboratory prototypes towards industrialized products. In this work, we thus challenged the industrialization process of a novel technological platform, based on an established research prototype of perfusion bioreactor, following a GMP-driven approach. We describe how the combination of scientific background, intellectual property, start-up factory environment, wise industrial advice in the biomedical field, design, and regulatory consultancy allowed us to turn a previously validated prototype technology into an industrial product suitable for serial production with improved replicability and user-friendliness. The solutions implemented enhanced aesthetics, ergonomics, handling, and safety of the bioreactor, and they allowed compliance with the fundamental requirements in terms of traceability, reproducibility, efficiency, and safety of the manufacturing process of advanced therapies medicinal products. The result is an automated incubator-compatible device, housing 12 disposable independent perfusion chambers for seeding and culture of any perfusable tissue. We validated the cell seeding process of the industrialized bioreactor by means of the Design of Experiment approach, whilst the effectiveness of perfusion culture was evaluated in the context of bone tissue engineering.

Original languageEnglish
Pages (from-to)405-415
JournalJournal of Tissue Engineering and Regenerative Medicine
Volume12
Issue number2
DOIs
Publication statusPublished - Feb 2018

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Bioreactors
Perfusion
Tissue Engineering
Tissue engineering
Intellectual Property
Technology
Safety
Incubators
Human Engineering
Intellectual property
Ergonomics
Esthetics
Research
Design of experiments
Industrial plants
Bone
Industrial Development
Tissue
Efficiency
Bone and Bones

Keywords

  • Journal Article

Cite this

Industrialization of a perfusion bioreactor : Prime example of a non-straightforward process. / Talò, G; Turrisi, C; Arrigoni, C; Recordati, C; Gerges, I; Tamplenizza, M; Cappelluti, A; Riboldi, S A; Moretti, M.

In: Journal of Tissue Engineering and Regenerative Medicine, Vol. 12, No. 2, 02.2018, p. 405-415.

Research output: Contribution to journalArticle

Talò, G, Turrisi, C, Arrigoni, C, Recordati, C, Gerges, I, Tamplenizza, M, Cappelluti, A, Riboldi, SA & Moretti, M 2018, 'Industrialization of a perfusion bioreactor: Prime example of a non-straightforward process', Journal of Tissue Engineering and Regenerative Medicine, vol. 12, no. 2, pp. 405-415. https://doi.org/10.1002/term.2480
Talò, G ; Turrisi, C ; Arrigoni, C ; Recordati, C ; Gerges, I ; Tamplenizza, M ; Cappelluti, A ; Riboldi, S A ; Moretti, M. / Industrialization of a perfusion bioreactor : Prime example of a non-straightforward process. In: Journal of Tissue Engineering and Regenerative Medicine. 2018 ; Vol. 12, No. 2. pp. 405-415.
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