Expansion of human mesenchymal stromal/stem cells in xeno-free conditions

Abstract

Background & Aim The long-term outlook for stem cell therapy predicts a shift toward better defined media and high-quality raw materials. Additionally, there is an increased need for cell therapy reagents compatible with microcarrier-based suspension culture platforms, allowing for both small scale studies and large-scale therapeutic manufacturing. Methods, Results & Conclusion Here, we examine the scale up process of human mesenchymal stromal/stem cells (hMSCs) using a novel high-quality xeno-free medium. We highlight the growth and characterization of hMSCs in planar and stirred-tank bioreactor growth platforms using xeno-free conditions throughout the entire process. Different xeno-free materials such as microcarriers and surface coatings are investigated to identify the best conditions compatible with our xeno-free MSC medium. In addition, certain steps and procedures are optimized because the xeno-free environment requires some adjustments. Results indicate that our newly developed medium delivers improved cell growth performance and supports a xeno-free process in both planar and microcarrier-based suspension culture. This xeno-free medium developed for hMSC expansion reliefs the immediate need for suspension-based clinical production, as well as future implementation of large-scale commercial manufacturing solutions for cell therapies. The long-term outlook for stem cell therapy predicts a shift toward better defined media and high-quality raw materials. Additionally, there is an increased need for cell therapy reagents compatible with microcarrier-based suspension culture platforms, allowing for both small scale studies and large-scale therapeutic manufacturing. Here, we examine the scale up process of human mesenchymal stromal/stem cells (hMSCs) using a novel high-quality xeno-free medium. We highlight the growth and characterization of hMSCs in planar and stirred-tank bioreactor growth platforms using xeno-free conditions throughout the entire process. Different xeno-free materials such as microcarriers and surface coatings are investigated to identify the best conditions compatible with our xeno-free MSC medium. In addition, certain steps and procedures are optimized because the xeno-free environment requires some adjustments.