The history and potential future of monoclonal antibody therapeutics development and manufacturing in four eras
Therapeutic monoclonal antibody (mAb) development and the processes for manufacturing drug substance have evolved since the first approval of the mAb in 1986. As the past is often the prologue to the future, the history of these technologies has been classified here into three eras, leading to specu...
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| Format: | Article |
| Language: | English |
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Taylor & Francis Group
2024-12-01
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| Series: | mAbs |
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| Online Access: | https://www.tandfonline.com/doi/10.1080/19420862.2024.2373330 |
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| _version_ | 1832576532484194304 |
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| author | Brian Kelley |
| author_facet | Brian Kelley |
| author_sort | Brian Kelley |
| collection | DOAJ |
| description | Therapeutic monoclonal antibody (mAb) development and the processes for manufacturing drug substance have evolved since the first approval of the mAb in 1986. As the past is often the prologue to the future, the history of these technologies has been classified here into three eras, leading to speculation about what the next era may hold with regard to development and manufacturing strategies, as well as the potential impacts to patients. The substantial increase in production culture titers and bioreactor production volumes and the availability of large-scale contract manufacturing facilities could translate into improved global access for these therapies and an expansion of indications for therapeutic antibodies. |
| format | Article |
| id | doaj-art-282bdaea7cf04bdfa53178386f2f0612 |
| institution | Kabale University |
| issn | 1942-0862 1942-0870 |
| language | English |
| publishDate | 2024-12-01 |
| publisher | Taylor & Francis Group |
| record_format | Article |
| series | mAbs |
| spelling | doaj-art-282bdaea7cf04bdfa53178386f2f06122025-01-31T04:19:38ZengTaylor & Francis GroupmAbs1942-08621942-08702024-12-0116110.1080/19420862.2024.2373330The history and potential future of monoclonal antibody therapeutics development and manufacturing in four erasBrian Kelley0Process & Product Development, Vir Biotechnology Inc, San Francisco, CA, USATherapeutic monoclonal antibody (mAb) development and the processes for manufacturing drug substance have evolved since the first approval of the mAb in 1986. As the past is often the prologue to the future, the history of these technologies has been classified here into three eras, leading to speculation about what the next era may hold with regard to development and manufacturing strategies, as well as the potential impacts to patients. The substantial increase in production culture titers and bioreactor production volumes and the availability of large-scale contract manufacturing facilities could translate into improved global access for these therapies and an expansion of indications for therapeutic antibodies.https://www.tandfonline.com/doi/10.1080/19420862.2024.2373330Cost of goodsglobal accessmanufacturing |
| spellingShingle | Brian Kelley The history and potential future of monoclonal antibody therapeutics development and manufacturing in four eras mAbs Cost of goods global access manufacturing |
| title | The history and potential future of monoclonal antibody therapeutics development and manufacturing in four eras |
| title_full | The history and potential future of monoclonal antibody therapeutics development and manufacturing in four eras |
| title_fullStr | The history and potential future of monoclonal antibody therapeutics development and manufacturing in four eras |
| title_full_unstemmed | The history and potential future of monoclonal antibody therapeutics development and manufacturing in four eras |
| title_short | The history and potential future of monoclonal antibody therapeutics development and manufacturing in four eras |
| title_sort | history and potential future of monoclonal antibody therapeutics development and manufacturing in four eras |
| topic | Cost of goods global access manufacturing |
| url | https://www.tandfonline.com/doi/10.1080/19420862.2024.2373330 |
| work_keys_str_mv | AT briankelley thehistoryandpotentialfutureofmonoclonalantibodytherapeuticsdevelopmentandmanufacturinginfoureras AT briankelley historyandpotentialfutureofmonoclonalantibodytherapeuticsdevelopmentandmanufacturinginfoureras |