2D To 3D Transition Of Mesenchymal Stem Cell Expansion Process Using The Sartorius MSC Pilot Solution

By Rupal P. Soder, Nathaniel Dudley, Mark Szczypka, David Splan, Grishma Patel, Racheli Wercberger, Julia Hupfield, Kyle Ritchie, Oren Ben-Yosef, Anna Quach, Kat Kozyrytska, and Maya Fuerstenau-Sharp

Mesenchymal Stem Cells (MSCs) are adult multipotent stem cells that can be isolated from various tissues such as bone marrow, adipose tissue, and umbilical cord (Wharton’s Jelly). These cells have the remarkable ability to modulate immune responses in vivo and can differentiate into several different cell types, such as osteoblasts, chondrocytes, and adipocytes. Due to their versatile therapeutic properties, MSCs are currently under extensive clinical investigation for the treatment of a wide range of diseases, which includes Graft-versus-Host Disease (GVHD), autoimmune disorders, and degenerative conditions. Given the substantial clinical cell number requirement for these therapeutic applications, it is crucial to manufacture large quantities of MSCs under current good manufacturing practices (cGMP). This necessitates the establishment of robust and scalable expansion processes during process development (PD) to ensure success at the manufacturing stage. Traditional workflows often rely on two-dimensional (2D) static methods for cell expansion. However, as the scale of production increases, these methods become increasingly unsustainable, leading to bottlenecks in production and supply, which in turn escalate costs and time to market for these life-changing therapies.

This application note details the rapid and successful transition of an established 2D planar culture process for the cultivation of Wharton’s Jelly MSCs (WJMSC) to a more efficient three-dimensional (3D) microcarrier-based suspension culture using the Sartorius MSC Pilot Solution. Discover how this innovative approach not only enhances the scalability of MSC production but also improves cell yield and quality, which addresses the critical challenges associated with large-scale manufacturing of MSCs for therapeutic use.