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Allogeneic cell therapy bioprocess economics and optimization: downstream processing decisions
To develop a decisional tool to identify the most cost effective process flowsheets for allogeneic cell therapies across a range of production scales. A bioprocess economics and optimization tool was built to assess competing cell expansion and downstream processing (DSP) technologies. Tangential fl...
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| Published in: | Regenerative medicine 2015-08, Vol.10 (5), p.591-609 |
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| Main Authors: | , , , , , |
| Format: | Article |
| Language: | English |
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| cited_by | cdi_FETCH-LOGICAL-c527t-fbd83b54e5cfd6b299ec22049a767cdd082bf7ff8fd6c0ad64b7543903df343f3 |
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| cites | cdi_FETCH-LOGICAL-c527t-fbd83b54e5cfd6b299ec22049a767cdd082bf7ff8fd6c0ad64b7543903df343f3 |
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| container_title | Regenerative medicine |
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| creator | Hassan, Sally Simaria, Ana S Varadaraju, Hemanthram Gupta, Siddharth Warren, Kim Farid, Suzanne S |
| description | To develop a decisional tool to identify the most cost effective process flowsheets for allogeneic cell therapies across a range of production scales.
A bioprocess economics and optimization tool was built to assess competing cell expansion and downstream processing (DSP) technologies.
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.
This analysis can facilitate early decision-making during process development. |
| doi_str_mv | 10.2217/rme.15.29 |
| format | article |
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A bioprocess economics and optimization tool was built to assess competing cell expansion and downstream processing (DSP) technologies.
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.
This analysis can facilitate early decision-making during process development.</description><identifier>ISSN: 1746-0751</identifier><identifier>EISSN: 1746-076X</identifier><identifier>DOI: 10.2217/rme.15.29</identifier><identifier>PMID: 26237703</identifier><language>eng</language><publisher>England: Future Medicine Ltd</publisher><subject>allogeneic cell therapy manufacture ; bioprocess economics ; Bioreactors - economics ; Cell Culture Techniques ; Cell Proliferation ; Cell- and Tissue-Based Therapy - methods ; centrifugation ; Cost-Benefit Analysis ; Decision Making ; downstream processing ; Economic aspects ; filling ; Humans ; Industry ; Medical economics ; Mesenchymal Stromal Cells ; Regenerative Medicine - economics ; Stem cell research ; Stem cell transplantation ; Stem Cell Transplantation - economics ; tangential flow filtration ; Transplantation, Homologous</subject><ispartof>Regenerative medicine, 2015-08, Vol.10 (5), p.591-609</ispartof><rights>S Farid</rights><rights>COPYRIGHT 2015 Future Medicine Ltd.</rights><rights>2015 Future Medicine Ltd</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c527t-fbd83b54e5cfd6b299ec22049a767cdd082bf7ff8fd6c0ad64b7543903df343f3</citedby><cites>FETCH-LOGICAL-c527t-fbd83b54e5cfd6b299ec22049a767cdd082bf7ff8fd6c0ad64b7543903df343f3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,780,784,27924,27925</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/26237703$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Hassan, Sally</creatorcontrib><creatorcontrib>Simaria, Ana S</creatorcontrib><creatorcontrib>Varadaraju, Hemanthram</creatorcontrib><creatorcontrib>Gupta, Siddharth</creatorcontrib><creatorcontrib>Warren, Kim</creatorcontrib><creatorcontrib>Farid, Suzanne S</creatorcontrib><title>Allogeneic cell therapy bioprocess economics and optimization: downstream processing decisions</title><title>Regenerative medicine</title><addtitle>Regen Med</addtitle><description>To develop a decisional tool to identify the most cost effective process flowsheets for allogeneic cell therapies across a range of production scales.
A bioprocess economics and optimization tool was built to assess competing cell expansion and downstream processing (DSP) technologies.
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.
This analysis can facilitate early decision-making during process development.</description><subject>allogeneic cell therapy manufacture</subject><subject>bioprocess economics</subject><subject>Bioreactors - economics</subject><subject>Cell Culture Techniques</subject><subject>Cell Proliferation</subject><subject>Cell- and Tissue-Based Therapy - methods</subject><subject>centrifugation</subject><subject>Cost-Benefit Analysis</subject><subject>Decision Making</subject><subject>downstream processing</subject><subject>Economic aspects</subject><subject>filling</subject><subject>Humans</subject><subject>Industry</subject><subject>Medical economics</subject><subject>Mesenchymal Stromal Cells</subject><subject>Regenerative Medicine - economics</subject><subject>Stem cell research</subject><subject>Stem cell transplantation</subject><subject>Stem Cell Transplantation - economics</subject><subject>tangential flow filtration</subject><subject>Transplantation, Homologous</subject><issn>1746-0751</issn><issn>1746-076X</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2015</creationdate><recordtype>article</recordtype><recordid>eNptkU1rVDEUhoMotlYX_gEJuNHFjPm8uXE3FD8KhW4quDLkJidjyr3JmNxLqb--GWasKCWL5OQ85-VNXoReU7JmjKoPZYI1lWumn6BTqkS3Iqr7_vThLOkJelHrDSGS95I9RyesY1wpwk_Rj8045i0kiA47GEc8_4Rid3d4iHlXsoNaMbic8hRdxTZ5nHdznOJvO8ecPmKfb1OdC9gJH_GYttiDi7X160v0LNixwqvjfoa-ff50ff51dXn15eJ8c7lykql5FQbf80EKkC74bmBag2OMCG1Vp5z3pGdDUCH0reuI9Z0YlBRcE-4DFzzwM_TuoNtM_FqgzmaKdf8emyAv1VBFGOm1JrShb_9Db_JSUnO3p6jkQkv-l9raEUxMIc_Fur2o2QgmGkdV16j1I1RbHtp_5QQhtvt_Bt4fBlzJtRYIZlfiZMudocTsszQtS0OlYbqxb45Gl2EC_0D-Ca8B8gCEZV4KVBchOTCHqk1EFxM8InwPA9Gs2w</recordid><startdate>20150801</startdate><enddate>20150801</enddate><creator>Hassan, Sally</creator><creator>Simaria, Ana S</creator><creator>Varadaraju, Hemanthram</creator><creator>Gupta, Siddharth</creator><creator>Warren, Kim</creator><creator>Farid, Suzanne S</creator><general>Future Medicine Ltd</general><scope>FUMOA</scope><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>3V.</scope><scope>7X7</scope><scope>7XB</scope><scope>88E</scope><scope>8AO</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>ABUWG</scope><scope>AFKRA</scope><scope>BENPR</scope><scope>CCPQU</scope><scope>EHMNL</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>K9.</scope><scope>M0S</scope><scope>M1P</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>PRINS</scope><scope>7X8</scope></search><sort><creationdate>20150801</creationdate><title>Allogeneic cell therapy bioprocess economics and optimization: downstream processing decisions</title><author>Hassan, Sally ; Simaria, Ana S ; Varadaraju, Hemanthram ; Gupta, Siddharth ; Warren, Kim ; Farid, Suzanne S</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c527t-fbd83b54e5cfd6b299ec22049a767cdd082bf7ff8fd6c0ad64b7543903df343f3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2015</creationdate><topic>allogeneic cell therapy manufacture</topic><topic>bioprocess economics</topic><topic>Bioreactors - economics</topic><topic>Cell Culture Techniques</topic><topic>Cell Proliferation</topic><topic>Cell- and Tissue-Based Therapy - methods</topic><topic>centrifugation</topic><topic>Cost-Benefit Analysis</topic><topic>Decision Making</topic><topic>downstream processing</topic><topic>Economic aspects</topic><topic>filling</topic><topic>Humans</topic><topic>Industry</topic><topic>Medical economics</topic><topic>Mesenchymal Stromal Cells</topic><topic>Regenerative Medicine - economics</topic><topic>Stem cell research</topic><topic>Stem cell transplantation</topic><topic>Stem Cell Transplantation - economics</topic><topic>tangential flow filtration</topic><topic>Transplantation, Homologous</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Hassan, Sally</creatorcontrib><creatorcontrib>Simaria, Ana S</creatorcontrib><creatorcontrib>Varadaraju, Hemanthram</creatorcontrib><creatorcontrib>Gupta, Siddharth</creatorcontrib><creatorcontrib>Warren, Kim</creatorcontrib><creatorcontrib>Farid, Suzanne S</creatorcontrib><collection>Future Medicine (Open Access)</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>ProQuest Central (Corporate)</collection><collection>Health & Medical Collection</collection><collection>ProQuest Central (purchase pre-March 2016)</collection><collection>Medical Database (Alumni Edition)</collection><collection>ProQuest Pharma Collection</collection><collection>Hospital Premium Collection</collection><collection>Hospital Premium Collection (Alumni Edition)</collection><collection>ProQuest Central (Alumni) (purchase pre-March 2016)</collection><collection>ProQuest Central (Alumni)</collection><collection>ProQuest Central</collection><collection>AUTh Library subscriptions: ProQuest Central</collection><collection>ProQuest One Community College</collection><collection>UK & Ireland Database</collection><collection>Health Research Premium Collection</collection><collection>Health Research Premium Collection (Alumni)</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Health & Medical Collection (Alumni Edition)</collection><collection>Medical Database</collection><collection>ProQuest One Academic Eastern Edition (DO NOT USE)</collection><collection>ProQuest One Academic</collection><collection>ProQuest One Academic UKI Edition</collection><collection>ProQuest Central China</collection><collection>MEDLINE - Academic</collection><jtitle>Regenerative medicine</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Hassan, Sally</au><au>Simaria, Ana S</au><au>Varadaraju, Hemanthram</au><au>Gupta, Siddharth</au><au>Warren, Kim</au><au>Farid, Suzanne S</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Allogeneic cell therapy bioprocess economics and optimization: downstream processing decisions</atitle><jtitle>Regenerative medicine</jtitle><addtitle>Regen Med</addtitle><date>2015-08-01</date><risdate>2015</risdate><volume>10</volume><issue>5</issue><spage>591</spage><epage>609</epage><pages>591-609</pages><issn>1746-0751</issn><eissn>1746-076X</eissn><abstract>To develop a decisional tool to identify the most cost effective process flowsheets for allogeneic cell therapies across a range of production scales.
A bioprocess economics and optimization tool was built to assess competing cell expansion and downstream processing (DSP) technologies.
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.
This analysis can facilitate early decision-making during process development.</abstract><cop>England</cop><pub>Future Medicine Ltd</pub><pmid>26237703</pmid><doi>10.2217/rme.15.29</doi><tpages>19</tpages><oa>free_for_read</oa></addata></record> |
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| ispartof | Regenerative medicine, 2015-08, Vol.10 (5), p.591-609 |
| issn | 1746-0751 1746-076X |
| language | eng |
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| source | Open Access: PubMed Central |
| subjects | allogeneic cell therapy manufacture bioprocess economics Bioreactors - economics Cell Culture Techniques Cell Proliferation Cell- and Tissue-Based Therapy - methods centrifugation Cost-Benefit Analysis Decision Making downstream processing Economic aspects filling Humans Industry Medical economics Mesenchymal Stromal Cells Regenerative Medicine - economics Stem cell research Stem cell transplantation Stem Cell Transplantation - economics tangential flow filtration Transplantation, Homologous |
| title | Allogeneic cell therapy bioprocess economics and optimization: downstream processing decisions |
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