Novel Single-Use Bioreactors for Scale-Up of Anchorage-Dependent Cell Manufacturing for Cell Therapies

This book chapter examines the challenges associated with scaling anchorage-dependent cell cultures from traditional planar systems to commercial bioreactor manufacturing. The authors review hydrodynamic effects, microcarrier suspension requirements, cell sensitivity to shear, and bioreactor design considerations relevant to cell therapy production. The chapter introduces Vertical-Wheel bioreactor technology as a scalable single-use platform designed to provide uniform mixing, efficient particle suspension, and low shear environments across multiple scales. Experimental results with mesenchymal stem cells and adherent cell cultures demonstrate favorable cell growth, aggregation behavior, and process scalability. The work provides foundational engineering and biological principles for bioprocess development of stem-cell-based and adherent cell therapy products.