Process Development For Scaled-up hESC/hiPSC Manufacturing

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 1010 PSCs in an 8 L volume of a Xcellerex disposable bioreactor.

CHALLENGE
To scale up, close and optimize a suspension-based manufacturing workflow for pluripotent stem cells (PSCs).

PROCESS DEVELOPED
A best-in-class, scalable manufacturing platform with closed passaging and in-line analytics.

OUTCOMES

• Scalable process capable of >10¹⁰ cells per batch
• 50% process time reduction
• Development of sample-free and closed workflows