Chemically controlled aggregation of pluripotent stem cells. Issue 8 (1st May 2018) - Lipsitz, Yonatan Y.
Abstract : Heterogeneity in pluripotent stem cell (PSC) aggregation leads to variability in mass transfer and signaling gradients between aggregates, resulting in heterogeneous differentiation and variability in product quality and yield. Lipsitz, Tonge, and Zandstra have characterized a chemical based method to control aggregate size within a specific, tunable range with low heterogeneity, reducing process variability in PSC expansion. This method enables controlled, scalable, stirred suspension based manufacturing of PSC cultures critical for the translation of regenerative medicine strategies to clinical products. Abstract: 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.