Innovation Showcase
With the ability to differentiate into all body tissue types and the potential for commercial scale manufacture, human induced Pluripotent Stem Cells (iPSCs) are an ideal starting material for the next generation of cellular therapeutics. However, inconsistency in the culture process can predispose cells to genetic abnormalities that can influence growth rate and differentiation efficiency. Persistence of these genetic alternations in the final product can introduce a safety risk to patients receiving these life altering therapies. Detecting genetic abnormalities is difficult, as no single assay can cover all potential alterations and may be at low levels that are below the detection limit of some assays. A combination of testing modalities at frequent and predetermined intervals can cover the most common genetic alterations and limit downstream risk. Similarly, culture strategies can be implemented to minimize the rate of de novo mutations and prevent abnormal colonies from overtaking genetically normal variants. This presentation will discuss the challenges of maintaining genetic integrity during the commercial manufacture of iPSCs and propose practical approaches to ensuring that clinical iPSCs are free of mutations for product development.