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Donor Variability in Growth Kinetics of Healthy hMSCs Using Manual Processing: Considerations for Manufacture of Cell Therapies

Detela, G; Bain, OW; Kim, H-W; Williams, DJ; Mason, C; Mathur, A; Wall, IB; (2018) Donor Variability in Growth Kinetics of Healthy hMSCs Using Manual Processing: Considerations for Manufacture of Cell Therapies. Biotechnology Journal , 13 (2) , Article 1700085. 10.1002/biot.201700085. Green open access

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Abstract

Human mesenchymal stromal cells (hMSCs) are excellent candidates for cell therapy but their expansion to desired clinical quantities can be compromised by ex vivo processing, due to differences between donor material and process variation. The aim of this article is to characterize growth kinetics of healthy baseline “reference” hMSCs using typical manual processing. Bone‐marrow derived hMSCs from ten donors are isolated based on plastic adherence, expanded, and analyzed for their growth kinetics until passage 4. Results indicate that hMSC density decreases with overall time in culture (p < 0.001) but no significant differences are observed between successive passages after passage 1. In addition, fold increase in cell number dropped between passage 1 and 2 for three batches, which correlated to lower performance in total fold increase and expansion potential of these batches, suggesting that proliferative ability of hMSCs can be predicted at an early stage. An indicative bounded operating window is determined between passage 1 and 3 (PDL < 10), despite the high inter‐donor variability present under standardized hMSC expansion conditions used. hMSC growth profile analysis will be of benefit to cell therapy manufacturing as a tool to predict culture performance and attainment of clinically‐relevant yields, therefore stratifying the patient population based on early observation.

Type: Article
Title: Donor Variability in Growth Kinetics of Healthy hMSCs Using Manual Processing: Considerations for Manufacture of Cell Therapies
Open access status: An open access version is available from UCL Discovery
DOI: 10.1002/biot.201700085
Publisher version: http://dx.doi.org/10.1002/biot.201700085
Language: English
Additional information: © 2018 The Authors. Biotechnology Journal Published by WILEY-VCH Verlag GmbH & Co. KGaA. This is an open access article under the terms of the Creative Commons Attribution License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited.
Keywords: Science & Technology, Life Sciences & Biomedicine, Biochemical Research Methods, Biotechnology & Applied Microbiology, Biochemistry & Molecular Biology, autologous cell therapies, bioprocess design, expansion potential, human mesenchymal stromal cells (hMSCs), variability, MESENCHYMAL STEM-CELLS, HUMAN BONE-MARROW, STROMAL CELLS, IN-VITRO, GENE-EXPRESSION, EXPANSION, MEDICINE, CULTURE, MAINTENANCE, PROGENITORS
URI: http://discovery.ucl.ac.uk/id/eprint/10046737
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