Advancing manufacture of human mesenchymal stem cells therapies: technological challenges in cell bioprocessing and characterization. (December 2018)

• Record Type: Journal Article
• Authors: Serra, Margarida; Cunha, Bárbara; Peixoto, Cristina; Gomes-Alves, Patrícia; Alves, Paula M
• Is Part Of: Current opinion in chemical engineering. Volume 22(2018)
• Page Start: 226
• Page End: 235
• Publication Date: 2018-12
• Subjects: Chemical engineering -- Periodicals; Chemical engineering; Periodicals; 660.05
• DOI: 10.1016/j.coche.2018.11.003
• Languages: English
• ISSNs: 2211-3398

Abstract

Graphical abstract: Highlights: Concise overview of current and future hMSC manufacturing challenges. Bioprocess engineering strategies for the expansion and downstream processing of hMSC. Analytical tools and potency assays for more accurate characterization of hMSC's CQA. Abstract : The use of human mesenchymal stem/stromal cells (hMSC) in clinical trials has been exponentially increasing over the last decade. To meet the high-growth demand for high quality hMSC products, much research and many reports have been published on bioprocess development for hMSC production in bioreactors, their downstream processing and on the development of analytical tools for standardization and harmonization of functional assays to assess hMSC potency. Here we discuss the last advances in hMSC manufacturing that have been designed through a better understanding of the attributes critical for assuring product quality, safety and therapeutic efficacy.