Cell and Tissue Transplantation and Therapy

As cell-based therapies begin to progress through Phase III clinical trials, there is an increasing need for the development of comprehensive cell banking strategies. In order to achieve commercial viability, both autologous and allogeneic approaches must have a comprehensive, end-to-end cell banking model—including proper collection, manufacturing and release criteria, cryopreservation and storage of cells, shipping, delivery, and logistics management of the final cell product. By developing an understanding of industry standards and best practices across these areas, companies can be better positioned to reduce research costs, improve efficiencies, create revenue streams, decrease time to discovery and, ideally, increase the likelihood and number of approved marketed products. The focus of this paper will be on cell banking strategies for autologous-based cell therapies with mesenchymal stromal cells, which are the most widely used cell type in cell therapy clinical trials today.