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Case Studies

Process Development for Scaled-up hESC/hiPSC Manufacturing

An optimized 14-day manufacturing workflow which produces > 10^10 , cells was developed in < 12 months

Released By CCRM

Introduction

Both human embryonic and induced pluripotent stem cells (hESCs and hiPSCs, together PSCs) have the ability to indefinitely self-renew and differentiate into any cell type. Stirred-tank reactors (STRs) for the large-scale expansion of PSCs have been reported by several groups and have the potential to generate clinically relevant amounts of cells. Here we report on a scale-up expansion seed train, able to produce 3.6 x 10^10 PSCs in an 8 L volume of a Xcellerex disposable bioreactor.

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