Cell-based therapeutics can be manufactured using either a centralized or decentralized model. ExoCyte is currently exploring a decentralized manufacturing model for ET-08. ExoCyte plans to produce Phase I material in a manual, semi-closed process which could then be transferred to a scalable, closed and automated manufacturing process following the success of initial clinical trials. This model allows for reduced capital investment to evaluate the product in Phase I, followed by transfer of the process in a timely manner to ensure a scalable and cost effective product supply for late stage clinical development and commercial supply.
We favor an ‘autonomous microfactory’ approach, where process automation is used to ensure that the manufacturing process is carried out in a way that can be reproduced to the same control strategy at different times and in different locations. This ensures that therapeutic production takes place closer to patients, reducing transit times and viability hurdles (see Figure 1 below).
A phased introduction of microfactories would allow ExoCyte to be capital-efficient until ET-08 can generate a positive return - capital investment would occur in line with market growth.