Allogeneic cell therapy bioprocess economics and optimization: downstream processing decisions

作者：Hassan Sally; Simaria Ana S; Varadaraju Hemanthram; Gupta Siddharth; Warren Kim; Farid Suzanne S^*

来源：Regenerative Medicine, 2015, 10(5): 591-609.

DOI：10.2217/rme.15.29

• allogeneic cell therapy manufacture
• bioprocess economics
• centrifugation
• downstream processing
• filling
• tangential flow filtration

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.

• 出版日期2015