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 medicin...Continue Reading
References
Jul 13, 2000·Proceedings of the National Academy of Sciences of the United States of America·G R BeckE Moran
Aug 3, 2001·Blood Cells, Molecules & Diseases·M W Long
Sep 19, 2002·FASEB Journal : Official Publication of the Federation of American Societies for Experimental Biology·Ming PeiLisa E Freed
Feb 6, 2004·Trends in Biotechnology·Ivan MartinMichael Heberer
Jul 9, 2005·Stem Cells·Alessandra BracciniIvan Martin
Apr 3, 2008·Biotechnology and Bioengineering·Chiara ArrigoniAndrea Remuzzi
Apr 5, 2008·Nature Protocols·Milica RadisicGordana Vunjak-Novakovic
Sep 2, 2008·Tissue Engineering. Part a·Mingyu ChengLisa E Freed
Oct 23, 2008·Cell Stem Cell·Daniel C Kirouac, Peter W Zandstra
Mar 18, 2009·Advances in Biochemical Engineering/biotechnology·D WendtI Martin
Jul 11, 2009·Tissue Engineering. Part B, Reviews·Petros LenasFrank P Luyten
Aug 4, 2009·Trends in Biotechnology·Anurag S Rathore
Aug 5, 2009·Trends in Biotechnology·Ivan MartinDavid Wendt
Dec 26, 2009·Biomaterials·Piia K ValonenLisa E Freed
Jun 10, 2010·Tissue Engineering. Part C, Methods·Saartje ImpensJan Schrooten
Aug 24, 2010·Acta Biomaterialia·Nandan L NerurkarRobert L Mauck
Oct 1, 2010·Advanced Materials·David WendtIvan Martin
Oct 12, 2010·Bone·Andrew B Yeatts, John P Fisher
Nov 9, 2010·Acta Biomaterialia·Jorge M SobralRui L Reis
Mar 31, 2011·Biotechnology and Bioengineering·Warren L GraysonGordana Vunjak-Novakovic
Apr 19, 2011·Tissue Engineering. Part B, Reviews·Juliane RauhMaik Stiehler
Jul 13, 2011·Tissue Engineering. Part a·Hongzhi ZhouHockin H K Xu
Sep 3, 2011·Biomaterials·Adebayo A AdebiyiKeith D Crawford
Sep 6, 2011·European Cells & Materials·Simon StephanSally Roberts
Sep 8, 2011·Tissue Engineering. Part C, Methods·Yantian ChenJan Schrooten
Feb 7, 2012·Journal of Cellular and Molecular Medicine·Subha N RathUlrich Kneser
Dec 21, 2012·Tissue Engineering. Part B, Reviews·Matthew B Fisher, Robert L Mauck
Feb 2, 2013·Biomechanics and Modeling in Mechanobiology·Michele M NavaRiccardo Pietrabissa
Jun 27, 2013·Tissue Engineering. Part C, Methods·Ioannis PapantoniouGreet Kerckhofs
Sep 4, 2013·BioMed Research International·Nasim Salehi-NikBehrouz Zandieh-Doulabi
Nov 27, 2014·Tissue Engineering. Part a·Ivan MartinJakob Passweg
Jul 15, 2015·Cellular Reprogramming·Marta BottagisioMatteo Moretti
Citations
Jul 22, 2020·Proceedings of the Institution of Mechanical Engineers. Part H, Journal of Engineering in Medicine·Hanieh NokhbatolfoghahaeiArash Khojasteh
Aug 31, 2020·Advanced Healthcare Materials·Paola AprileTeresa Simon-Yarza
Nov 18, 2018·Scientific Reports·Roberta VisoneMatteo Moretti
Apr 10, 2019·Annals of Biomedical Engineering·Giuseppe TalòArianna B Lovati
Apr 10, 2019·Biotechnology Journal·Sébastien de BournonvilleLiesbet Geris
Feb 13, 2021·Biofabrication·Valerio Luca MainardiMatteo Moretti