iPSceller

iPSceller is a term used to describe a platform concept for scalable production of induced pluripotent stem cells (iPSCs). It encompasses hardware, software, and process methodologies intended to support large-scale culture of iPSCs while maintaining quality and safety. The concept reflects the need to translate iPSC technology from laboratory research to clinically and commercially viable manufacturing.

A typical iPSceller design features modular, closed, GMP-compliant bioreactor units, automated cell handling, and integrated analytics. It employs defined, xeno-free media, controlled bioprocess parameters, and scalable culture configurations such as suspension growth with microcarriers or aggregate-based systems. Real-time monitoring tracks cell viability, pH, oxygen, nutrient usage, and markers of pluripotency.

Workflow and quality control: The system supports automated passaging, plating, and harvest, with traceability from donor material to final product. Quality control includes sterility testing, mycoplasma detection, identity and potency assays, genomic stability checks, and evaluation of differentiation potential. Comprehensive data management and standard operating procedures are emphasized to ensure reproducibility and regulatory readiness.

Applications and regulatory context: iPSceller concepts aim to enable disease modeling, drug discovery, and the production of cell-based therapies. Practical challenges include maintaining genomic integrity, potential immunogenicity, cost, and the need for harmonized manufacturing standards. As a concept, iPSceller informs discussions of scalable iPSC manufacturing, though no single universal platform has been adopted.