Heterogeneity in pluripotent stem cell (PSC) aggregation leads to variability in mass transfer and signaling gradients between aggregates, which results in heterogeneous differentiation and therefore variability in product quality and yield. We have characterized a chemical-based method to control aggregate size within a specific, tunable range with low heterogeneity, thereby reducing process variability in PSC expansion. This method enables controlled, scalable, stirred suspension-based manufacturing of PSC cultures that are critical for the translation of regenerative medicine strategies to clinical products.
Keywords: aggregation; bioreactor: pluripotent stem cell (PSC); process variability; stem cells.
© 2018 The Authors. Biotechnology and Bioengineering Published by Wiley Periodicals, Inc.