Pall Xpansion® Bioreactor Supports Progenitor Cell Growth to >1 Million cells/cm2 and Proper Cell Differentiation

Abstract

Background & Aim With the recent increase in early phase cell therapy clinical trials, there is a need for a manufacturing platform which can be implemented in research labs and easily scaled up to expedite process development studies, pre-clinical testing, and large-scale expansion of adherent human cells. Although various platforms such as traditional flatware and stirred tank bioreactors with microcarriers exist and have been well characterized, traditional flatware often does not allow for tight control of the cellular environment and is not scalable. Pall's Xpansion single-use bioreactor offers a tightly-controlled, scalable manufacturing platform for cell therapy applications, allowing for expedited process development, pre-clinical testing and large scale, high-density expansion of progenitor cells while maintaining their differentiation capacity. Methods, Results & Conclusion We have previously demonstrated efficient expansion of both epithelial cells (Vero, HEK293), human mesenchymal stem/stromal cells (hMSC), and progenitor cells in the Xpansion single-use bioreactor. Here we extend the progenitor cell findings by successfully expanding a proprietary progenitor cell to extremely high cell densities (> 1 million cells/cm2) reproducibly for 8 batches. In summary, all batches resulted in 1) cell expansion to > 1 million cells/cm2 and equivalent cell densities to the traditional flatware process control; 2) equivalent differentiation to a more mature cell fate as indicated by expression of key cell surface markers; and 3) self-assembly into characteristic three-dimensional structures.