Allogeneic cell therapy bioprocess economics and optimization: downstream processing decisions
- PMID: 26237703
- DOI: 10.2217/rme.15.29
Allogeneic cell therapy bioprocess economics and optimization: downstream processing decisions
Erratum in
-
Corrigendum.Regen Med. 2015 Nov;10(8):1045. doi: 10.2217/rme.15.75. Epub 2015 Dec 2. Regen Med. 2015. PMID: 26625985 No abstract available.
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: allogeneic cell therapy manufacture; bioprocess economics; centrifugation; downstream processing; filling; tangential flow filtration.
Similar articles
-
Allogeneic cell therapy bioprocess economics and optimization: single-use cell expansion technologies.Biotechnol Bioeng. 2014 Jan;111(1):69-83. doi: 10.1002/bit.25008. Epub 2013 Aug 16. Biotechnol Bioeng. 2014. PMID: 23893544 Free PMC article.
-
Allogeneic and autologous mode of stem cell transplantation in regenerative medicine: which way to go?Med Hypotheses. 2014 Dec;83(6):787-91. doi: 10.1016/j.mehy.2014.10.010. Epub 2014 Oct 19. Med Hypotheses. 2014. PMID: 25456787
-
Decisional tool for cost of goods analysis of bioartificial liver devices for routine clinical use.Cytotherapy. 2021 Aug;23(8):683-693. doi: 10.1016/j.jcyt.2021.04.006. Epub 2021 Jun 9. Cytotherapy. 2021. PMID: 34116945
-
Allogeneic cell therapy manufacturing: process development technologies and facility design options.Expert Opin Biol Ther. 2017 Oct;17(10):1201-1219. doi: 10.1080/14712598.2017.1354982. Epub 2017 Jul 20. Expert Opin Biol Ther. 2017. PMID: 28699788 Review.
-
The systematic production of cells for cell therapies.Cell Stem Cell. 2008 Oct 9;3(4):369-81. doi: 10.1016/j.stem.2008.09.001. Cell Stem Cell. 2008. PMID: 18940729 Review.
Cited by
-
Ex vivo Manufactured Neutrophils for Treatment of Neutropenia-A Process Economic Evaluation.Front Med (Lausanne). 2019 Mar 1;6:21. doi: 10.3389/fmed.2019.00021. eCollection 2019. Front Med (Lausanne). 2019. PMID: 30881955 Free PMC article.
-
Critical Analysis of cGMP Large-Scale Expansion Process in Bioreactors of Human Induced Pluripotent Stem Cells in the Framework of Quality by Design.BioDrugs. 2021 Nov;35(6):693-714. doi: 10.1007/s40259-021-00503-9. Epub 2021 Nov 2. BioDrugs. 2021. PMID: 34727354 Free PMC article. Review.
-
Bioprocess Economic Modeling: Decision Support Tools for the Development of Stem Cell Therapy Products.Bioengineering (Basel). 2022 Dec 11;9(12):791. doi: 10.3390/bioengineering9120791. Bioengineering (Basel). 2022. PMID: 36550997 Free PMC article. Review.
-
Particle movement and fluid behavior visualization using an optically transparent 3D-printed micro-hydrocyclone.Biomicrofluidics. 2020 Nov 19;14(6):064106. doi: 10.1063/5.0025391. eCollection 2020 Nov. Biomicrofluidics. 2020. PMID: 33269035 Free PMC article.
-
Protection of human induced pluripotent stem cells against shear stress in suspension culture by Bingham plastic fluid.Biotechnol Prog. 2021 Mar;37(2):e3100. doi: 10.1002/btpr.3100. Epub 2020 Nov 28. Biotechnol Prog. 2021. PMID: 33169533 Free PMC article.
Publication types
MeSH terms
LinkOut - more resources
Full Text Sources
Other Literature Sources
Miscellaneous
