Allogeneic Cell Therapy Bioprocess Economics and Optimization: Downstream Processing Decisions
Authors:
Open Access
- 3 August 2015
- journal article
- Published by Taylor & Francis in Regenerative Medicine
- Vol. 10 (5) , 591-609
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.Keywords
This publication has 10 references indexed in Scilit:
- Standardization of Good Manufacturing Practice–compliant production of bone marrow–derived human mesenchymal stromal cells for immunotherapeutic applicationsCytotherapy, 2015
- Gamma irradiation preserves immunosuppressive potential and inhibits clonogenic capacity of human bone marrow‐derived mesenchymal stromal cellsJournal of Cellular and Molecular Medicine, 2014
- Allogeneic cell therapy bioprocess economics and optimization: Single‐use cell expansion technologiesBiotechnology and Bioengineering, 2013
- Assessing Commercial Opportunities for Autologous and Allogeneic Cell-Based ProductsRegenerative Medicine, 2012
- Fed‐batch and perfusion culture processes: Economic, environmental, and operational feasibility under uncertaintyBiotechnology and Bioengineering, 2012
- Cryopreserved mesenchymal stromal cells display impaired immunosuppressive properties as a result of heat-shock response and impaired interferon-γ licensingCytotherapy, 2012
- Highly efficient large-scale lentiviral vector concentration by tandem tangential flow filtrationJournal of Virological Methods, 2011
- The Systematic Production of Cells for Cell TherapiesCell Stem Cell, 2008
- Decision-Support Tool for Assessing Biomanufacturing Strategies under Uncertainty: Stainless Steel versus Disposable Equipment for Clinical Trial Material PreparationBiotechnology Progress, 2008
- New developments in affinity chromatography with potential application in the production of biopharmaceuticalsJournal of Biochemical and Biophysical Methods, 2001