Achieving Clinical Quality For Human iPSC Generation And Expansion

Advancing induced pluripotent stem cell (iPSC) therapies requires workflows that translate from research to regulated manufacturing without compromising quality or scalability. Insights from Catalent and Miltenyi Biotec highlight how GMP-aligned processes are being implemented across the iPSC lifecycle—from controlled generation and expansion to reproducible, closed-system production. Practical considerations include media selection, automation with the CliniMACS Prodigy® platform, and strategies to maintain cell quality and consistency at scale using iPS-Brew GMP Medium. Together, see how these perspectives provide a clearer path to standardizing PSC manufacturing while reducing variability and operational complexity.