Sally Hassan1, Ana S Simaria1, Hemanthram Varadaraju2,3, Siddharth Gupta2, Kim Warren2, Suzanne S Farid1. 1. The Advanced Centre for Biochemical Engineering, Department of Biochemical Engineering, University College London, Gordon Street, London WC1H 0AH, UK. 2. Development Services, Cell Therapy, Lonza Walkersville, Inc., 8830 Biggs Ford Road, US - 21793-0127 Walkersville, MD, USA. 3. Modern Meadow, 140 58 Street Building A, Suite 8J Brooklyn, NY 11220, USA.
Abstract
AIM: To develop a decisional tool to identify the most cost effective process flowsheets for allogeneic cell therapies across a range of production scales. MATERIALS & METHODS: A bioprocess economics and optimization tool was built to assess competing cell expansion and downstream processing (DSP) technologies. RESULTS: Tangential flow filtration was generally more cost-effective for the lower cells/lot achieved in planar technologies and fluidized bed centrifugation became the only feasible option for handling large bioreactor outputs. DSP bottlenecks were observed at large commercial lot sizes requiring multiple large bioreactors. The DSP contribution to the cost of goods/dose ranged between 20-55%, and 50-80% for planar and bioreactor flowsheets, respectively. CONCLUSION: This analysis can facilitate early decision-making during process development.
AIM: To develop a decisional tool to identify the most cost effective process flowsheets for allogeneic cell therapies across a range of production scales. MATERIALS & METHODS: A bioprocess economics and optimization tool was built to assess competing cell expansion and downstream processing (DSP) technologies. RESULTS: Tangential flow filtration was generally more cost-effective for the lower cells/lot achieved in planar technologies and fluidized bed centrifugation became the only feasible option for handling large bioreactor outputs. DSP bottlenecks were observed at large commercial lot sizes requiring multiple large bioreactors. The DSP contribution to the cost of goods/dose ranged between 20-55%, and 50-80% for planar and bioreactor flowsheets, respectively. CONCLUSION: This analysis can facilitate early decision-making during process development.
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