A novel serum- and xeno-free medium for the expansion of human mesenchymal stromal/stem cells.

Background & Aim The long-term outlook for stem cell therapy predicts an increased need for better defined medium and high quality raw materials. Human mesenchymal stromal/stem cells (hMSCs) are an attractive target for clinical study as therapeutic agents. Large scale manufacturing of these adherent-dependent cells necessitates adoption of technologies such as stirred tank bioreactors where suspension culture using microcarriers is enabled. Cell culture medium and supplements are critical factors of the scale-up process. Many processes currently include fetal bovine serum (FBS) which is a commonly-used supplement associated with regulatory, supply, and consistency challenges. Methods, Results & Conclusion Here, we show the performance of a novel serum- and xeno-free cell culture medium developed for the expansion of hMSCs. This medium enables scale-up from planar culture to suspension culture in stirred tank bioreactors using microcarriers. In addition to consistent and good growth performance in both planar and suspension systems, the hMSCs expanded in this culture medium maintain all the characteristics of multipotency. The medium is manufactured under cGMP conditions using raw materials selected for high quality and suitability for manufacturing applications and does not contain phenol red. This novel serum- and xeno-free medium developed for hMSC expansion supports the future implementation of large scale, commercial manufacturing solutions for allogeneic therapies that will be required following clinical success.