Good Manufacturing Practice (GMP) Translation of Advanced Cellular Therapeutics: Lessons for the Manufacture of Erythrocytes as Medicinal Products.

Blood transfusion is a mainstay of modern medical practice. In many parts of the world the use of this life-saving therapy is hampered by issues of supply and the potential for transfusion transmitted infections. Accordingly, there are many studies seeking to find an alternative to donated red blood cells (RBCs) for transfusion, including large-scale production from adult and pluripotent stem cells, or erythroid cell lines. Translating basic studies, using any cell lineage, into protocols that are suitable for the generation of cellular therapies requires a wide range of biological and regulatory procedures to be put in place. Additionally, there are specific challenges for the production of RBCs caused by the number of cells needed for a single dose (approx. 1-2 × 1012 ). In this chapter, we will review critical areas in the development and good manufacturing practice (GMP) translation of cellular therapeutics through to early phase clinical trials and how this learning can be applied to in vitro RBC therapies.