Clinical Human Cell Production System for Broad Use

The therapeutic potential of patient-specific cultured cells continues to rapidly grow for a range of medical needs, such as regenerative repair of damaged tissue, cancer, and infectious diseases. As a result, the motivation to commercialize patient-specific "cell products" is increasing rapidly as well. A large unmet need exists for the development of reliable clinical and commercial ceil manufacturing capability for these cell products in compliance with increasingly strict regulatory guidelines and where the production economics are more favorable so that the benefits of cell therapy can be more widely enjoyed. In Phase I, a prototype system was defined and constructed that incorporated Aastrom's single-pass perfusion technology for highly effective primary human cell production along with a sterile, closed fluid path and a robotic instrument to perform operational steps (e.g. priming, inoculation, harvest). The approach provides general flexibility to enable researchers to develop and optimize a wide range of production processes, over a variety of cell types, as well.as cost-effective scale-up to clinical and commercial cell manufacturing. A non-adherent T-Cell process and an adherent stromal cell process were successfully demonstrated with the prototype. In Phase II, process control methods and additional automation technology will be developed, a modular configuration strategy will be defined, system components developed to enable cell manufacturing over a wide range of scale, and a test configuration constructed and tested to validate the design. Successful completion of Phase II will provide the technology and results necessary to initiate a commercialization phase to include both the use of the modular system as component technology to support commercialization of Aastrom's proprietary Tissue Repair Cell (TRC) products as well as the direct commercialization of the system for use by other institutions planning to commercialize therapeutic cell products.