Session Details

Fast Forward to hMSCs Manufacturing: A Novel, Xeno-Free Medium Supporting Planar and Suspension Formats For Easy Scale-Up (Global Showcase Presentation Hosted By Merck)
Thursday, May 30, 2019 01:15 PM - 01:30 PM 
ISCT Global Showcase Lounge (Exhibit Hall)
Kathleen Ongena, PhD , Head of Biomaterials and Assays, Cell Therapy Bioprocessing, Merck, United States

The long-term outlook for stem cell therapy predicts an increased need for better defined media 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 media and supplements are critical factors of the scale-up process. Many processes currently include fetal bovine serum (FBS), a commonly-used supplement associated with regulatory, supply, and consistency challenges.

Here, we show the performance of a novel, xeno-free cell culture media formulation developed for the expansion of hMSCs in multiple cell culture platforms. We highlight the growth and characterization of hMSCs in planar, spinner, and stirred tank bioreactor growth platforms. Results indicate the medium delivers improved growth performance compared to a benchmark medium while maintaining expected characteristics of multipotency.

This xeno-free medium developed for hMSC expansion supports the immediate need for suspension-based clinical production as well as future implementation of large scale, commercial manufacturing solutions for allogeneic therapies that will be required
following clinical success.

Kathleen Ongena PhD
Head of Biomaterials and Assays, Cell Therapy Bioprocessing