Identifying and optimizing critical process parameters for large-scale manufacturing of iPSC derived insulin-producing β-cells.

ABSTRACT:

Background

Type 1 diabetes, an autoimmune disorder leading to the destruction of pancreatic β-cells, requires lifelong insulin therapy. Islet transplantation offers a promising solution but faces challenges such as limited availability and the need for immunosuppression. Induced pluripotent stem cells (iPSCs) provide a potential alternative source of functional β-cells and have the capability for large-scale production. However, current differentiation protocols, predominantly conducted in hybrid or 2D settings, lack scalability and optimal conditions for suspension culture.

Methods

We examined a range of bioreactor scaleup process parameters and quality target product profiles that might affect the differentiation process. This investigation was conducted using an optimized

SUBMITTER: Yehya H 

PROVIDER: S-EPMC11550522 | biostudies-literature | 2024 Nov

REPOSITORIES: biostudies-literature