Comparative study for the production of monoclonal antibodies in single‐use vs stainless steel bioreactors based on product quality and stress factor
Abstract Single‐use bioreactors (SUB) and stainless steel bioreactors (SSB) differ in their physical properties. This can have an effect on the performed processes. To be able to guarantee flexible planning in a facility, any kind of processes in SUB and SSB must be sufficiently similar. To date, as...
| Main Authors: | , , , |
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| Format: | Article |
| Language: | English |
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Wiley
2020-07-01
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| Series: | Engineering Reports |
| Subjects: | |
| Online Access: | https://doi.org/10.1002/eng2.12197 |
| _version_ | 1818488449593769984 |
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| author | Christian Beck Silke Werz Alexander Herrmann Christoph T. A. Meiringer |
| author_facet | Christian Beck Silke Werz Alexander Herrmann Christoph T. A. Meiringer |
| author_sort | Christian Beck |
| collection | DOAJ |
| description | Abstract Single‐use bioreactors (SUB) and stainless steel bioreactors (SSB) differ in their physical properties. This can have an effect on the performed processes. To be able to guarantee flexible planning in a facility, any kind of processes in SUB and SSB must be sufficiently similar. To date, assessments of SUB and SSB have been exclusively specific for one single product. This study shows a general nonproduct‐specific comparison of the production of different types of monoclonal antibodies in different scales of SUBs and SSBs. The study is set up with 72 clinical manufacturing fermentation runs in total by comparing the cell culture performance and quality attributes of these two bioreactor systems. The outcome is that SUBs and SSBs can produce monoclonal antibodies with comparable cell culture performance and product quality. This general comparability paves the way for SUBs to produce new and existing products for (clinical) manufacturing. |
| first_indexed | 2024-12-10T16:51:09Z |
| format | Article |
| id | doaj.art-3eee49f794aa4b85a4552c5e87fa4c55 |
| institution | Directory Open Access Journal |
| issn | 2577-8196 |
| language | English |
| last_indexed | 2024-12-10T16:51:09Z |
| publishDate | 2020-07-01 |
| publisher | Wiley |
| record_format | Article |
| series | Engineering Reports |
| spelling | doaj.art-3eee49f794aa4b85a4552c5e87fa4c552022-12-22T01:40:53ZengWileyEngineering Reports2577-81962020-07-0127n/an/a10.1002/eng2.12197Comparative study for the production of monoclonal antibodies in single‐use vs stainless steel bioreactors based on product quality and stress factorChristian Beck0Silke Werz1Alexander Herrmann2Christoph T. A. Meiringer3Roche Diagnostics GmbH Pharma Biotech Penzberg Penzberg GermanyRoche Diagnostics GmbH Pharma Biotech Penzberg Penzberg GermanyRoche Diagnostics GmbH Pharma Biotech Penzberg Penzberg GermanyRoche Diagnostics GmbH Pharma Biotech Penzberg Penzberg GermanyAbstract Single‐use bioreactors (SUB) and stainless steel bioreactors (SSB) differ in their physical properties. This can have an effect on the performed processes. To be able to guarantee flexible planning in a facility, any kind of processes in SUB and SSB must be sufficiently similar. To date, assessments of SUB and SSB have been exclusively specific for one single product. This study shows a general nonproduct‐specific comparison of the production of different types of monoclonal antibodies in different scales of SUBs and SSBs. The study is set up with 72 clinical manufacturing fermentation runs in total by comparing the cell culture performance and quality attributes of these two bioreactor systems. The outcome is that SUBs and SSBs can produce monoclonal antibodies with comparable cell culture performance and product quality. This general comparability paves the way for SUBs to produce new and existing products for (clinical) manufacturing.https://doi.org/10.1002/eng2.12197bioreactorcomparisonfermentationmonoclonal antibodysingle‐usestainless steel |
| spellingShingle | Christian Beck Silke Werz Alexander Herrmann Christoph T. A. Meiringer Comparative study for the production of monoclonal antibodies in single‐use vs stainless steel bioreactors based on product quality and stress factor Engineering Reports bioreactor comparison fermentation monoclonal antibody single‐use stainless steel |
| title | Comparative study for the production of monoclonal antibodies in single‐use vs stainless steel bioreactors based on product quality and stress factor |
| title_full | Comparative study for the production of monoclonal antibodies in single‐use vs stainless steel bioreactors based on product quality and stress factor |
| title_fullStr | Comparative study for the production of monoclonal antibodies in single‐use vs stainless steel bioreactors based on product quality and stress factor |
| title_full_unstemmed | Comparative study for the production of monoclonal antibodies in single‐use vs stainless steel bioreactors based on product quality and stress factor |
| title_short | Comparative study for the production of monoclonal antibodies in single‐use vs stainless steel bioreactors based on product quality and stress factor |
| title_sort | comparative study for the production of monoclonal antibodies in single use vs stainless steel bioreactors based on product quality and stress factor |
| topic | bioreactor comparison fermentation monoclonal antibody single‐use stainless steel |
| url | https://doi.org/10.1002/eng2.12197 |
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