SBIR Phase II: Clinical-Scale Suspension Bioreactor for Primary Hematopoietic Culture

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This Small Business Innovation Research Phase II project describes thedevelopment of a disposable, highly efficient suspension bioreactor for primary hematopoietic (blood cell-forming) cell culture. The unique challenges (heterogeneous nature, donor variability, and shear-sensitivity)of these cultures render traditional flask or suspension cultures unable to economically and consistently produce large quantities of cells. In Phase I, the feasibility and characteristics of a disposable suspension bioreactor was demonstrated. In Phase II, a scaled-up prototype of a large, agitated disposable bioreactor designed for clinical use (stem cell transplantation) will be constructed, characterized, and tested for reliability and durability. Gas and mass transfer correlations established in Phase I will be verified and extended. The use of medium optical density as a surrogate measure for cell density will be investigated.The final product will be a system that combines the simple, disposable nature of flask culture with the control and monitoring capabilities of a suspension bioreactor. The resulting system will enable the cost-effective production of large numbers of primary hematopoietic cells and will improve the effectivenessand decrease the cost of medical procedures in the fields of transplantation, immunotherapy, and gene therapy.