466. Manufacturing Solutions for Robust Cell Therapy Expansion and Harvest

The long-term view of regenerative medicine therapies predicts an increased need for expansion solutions that ease scalability, utilize animal origin-free materials and are compatible with limited downstream processing steps. As more cell therapeutics progress through clinical testing, current in vitro culture methods are proving cumbersome to scale and lack robustness. Moreover, high quality animal origin-free reagents and downstream processing devices support the future implementation of large scale manufacturing solutions that will be required following clinical success. Here, we describe the implementation of single use bioreactors and high quality media for expansion of cell therapies. We include examples from allogeneic mesenchymal stem cells and autologous T cells. The presentation will review solutions addressing animal origin-free expansion of cells within the context of different upstream process development steps as well as scaling and downstream processing with good cell quality, high recovery, high viability and good activity. Start to finish solutions for expansion and harvest, including high quality reagents, are key enabling technologies for success in commercializing cell therapies.