Approaches for scaling up stem cells used in therapeutic process

Cell therapy is one of the most fastest-growing segments in the life sciences. Involves the delivery of living cells to a patient for the treatment of disease. Cell therapy offers a promising clinical approach in treatment of diseases. Both induced pluripotent stem cells and embryonic stem cells are known for their potential use in drug screening, disease modeling study and cell-based therapy. Induced pluripotent derived stem cells (iPSCs) have been used in a wide variety of small and large animal models to treat many different diseases, as it holds a great potential to generate novel and curative cell therapy products. Human induced pluripotent stem cells (hiPSCs) has a great scope of application in regenerative medicine due to their inherent ability to self-renew and differentiate into cells from three embryonic germ layers. Scalable and standardized culture processes of hiPSCs produced in large quantities are required for clinical applications, but the current methods to generate novel therapies do not meet commercial and clinical demands, lack scalability, requires large footprint and labor‐intensive, hence it is essential to develop scalable manufacturing processes that accommodates the generation of high-quality iPSCs derivatives under controlled conditions. The current methods for scaling up cell therapy process is based on empirical and geometry-dependent methods which does not precisely represent the hydrodynamics of 3D bioreactors as it requires multiple iterations of scale up studies that results in increased timeand development cost.