Custom Serum-Free Media Development & Optimization: A Molecular Approach to Productivity & Quality
Jessie H.-T. Ni, PhD. Chief Scientific Officer, Irvine Scientific
Abstract: The addition of animal sera into basal culture media is often used for maximal cell expansion. However, there are many clinical and scientific challenges associated with serum-containing media. Aside from the potential safety risk of pathogen transmission, the limited availability of serum also makes it a bottleneck in bringing cell therapies to the commercial scale. Furthermore, due to the batch-to-batch variability, serum also poses a scientific burden in the process of designing a defined, controlled environment for cell expansion and manipulation. In this presentation, I will illustrate the rational design and molecular approaches we took in developing and optimizing serum-free media for specific expansion of primary cells and stem cells, using T cells and mesenchymal stem cells as examples. From this "quality-by-design" media optimization process, key cellular expression markers were often identified and used to determine the final media performance.
Process Development Strategies Toward Serum-Free Liter-Scale Expansion of Human Mesenchymal Stem Cells
Qasim Rafiq, PhD. E-TERM Research Fellow, Loughborough University
Abstract: Human mesenchymal stem/ stromal cells (MSCs) are a promising candidate for cell-based therapies, tissue engineering and regenerative medicine applications due to their multipotency, propensity to grow in-vitro, ease of isolation and immune modulatory properties. However, the effective transfer of MSCs into widespread clinical applications will depend on utilizing key bioprocessing practices to produce quality cells at the capacity required to meet the clinical need. By using a liter-scale, microcarrier-based bioreactor system, we were able to generate quantitative data from MSCs cultured in serum. However the need to eliminate variability from the bioprocess led us to investigate the monolayer growth of MSCs in various commercially available serum-free media. I will present our findings of the cellular metabolite flux, cell surface marker expressions, and growth of MSCs. Lastly, I will also discuss different cost driving factors associated serum and serum-free MSC culture systems for clinical usage.