197 - Functional & economic comparability of Xeno-free stem cell bioprocess system

Abstract

Human Mesenchymal Stem Cells (hMSCs) are key raw material in Regenerative Medicine and are widely used for therapeutics, engineered tissues, and medical devices. Major challenges for manufacturing this key raw material lies in the culture time, cost and media used for cultivating the hMSCs. Here, we developed an efficient and robust xeno-free media that will both reduce the manufacturing cost and decrease the regulatory burden associated with bovine serum components found in traditional culture media. We evaluated and compared hMSCs quality parameters in bovine serum-containing and xeno-free media formulations and assessed the cells quality parameters such as cell identity, potency and functionality. hMSC derived in xeno-free media maintain critical functional properties including angiogenic cytokine (FGF, HGF, IL8, TIMP1, TIMP2, and VEGF) secretion, trilineage differentiation, and immunomodulatory potential. In addition, these cells expand rapidly and achieved confluency within 4–5 days of culture without media exchange. The economics of hMSC expansion in this xeno-free media were modeled and compared to other competitive hMSC cell or media systems where it consistently outperformed traditional hMSC systems by more than 8-fold on the critical productivity metric of Million cells per Liter media consumed. The rapid growth and minimal manipulation required with the xeno-free bioprocess media streamlines manufacturing and minimizes the cost of production, making it ideal for use as a commercial platform for various regenerative medicine applications.