Scale up manufacturing approach for production of human induced pluripotent stem cell-derived islets using Vertical Wheel® bioreactors.

ABSTRACT: Advanced protocols show potential for human stem cells (SC)-derived islets generation under planar (2D) alone or three-dimensional (3D) cultures, but show challenges in scalability, cell loss, and batch-to-batch consistency. This study explores Vertical Wheel (VW)® bioreactor suspension technology to differentiate islets from human induced pluripotent stem cells, achieving uniform, transcriptionally mature, and functional SC-islets. A 5x increase in scale from 0.1 L to 0.5 L reactors resulted in a 12-fold (15,005-183,002) increase in islet equivalent count (IEQ) without compromising islet structure. SC-islets show enriched β-cell composition (~63% CPPT⁺NKX6.1⁺ISL1⁺), glucose responsive insulin release (3.9-6.1-fold increase), and reversed diabetes in STZ-tr

SUBMITTER: Dadheech N 

PROVIDER: S-EPMC12122946 | biostudies-literature | 2025 May

REPOSITORIES: biostudies-literature