Cell Therapies require sufficient manufacturing process control to guarantee clinical efficacy and sufficient scalability and economic performance to supply the target population. Despite an increasing move towards automation and engineering informed process design and control, significant improvements are still required.

Red blood cells are an example of an exceedingly high dose cell therapy, and manufacture of these cells represents a correspondingly difficult challenge. The presentation will discuss strategy and progress in establishing an ultra-high efficiency and scalable production process (in excess of 1E8 cells/mL in Litre+ stirred tank reactors) for manufactured red cells with broader applicability for development of other cell therapy manufacturing processes. Further, we will discuss the development and application of kinetic modelling tools that are required to support process development and optimisation of complex cell cultures.