Accelerating attribute-focused process and product development through the development and deployment of autonomous process analytical technology platform system
© 2024 Wiley Periodicals LLC..
Enabling real-time monitoring and control of the biomanufacturing processes through product quality insights continues to be an area of focus in the biopharmaceutical industry. The goal is to manufacture products with the desired quality attributes. To realize this rigorous attribute-focused Quality by Design approach, it is critical to support the development of processes that consistently deliver high-quality products and facilitate product commercialization. Time delays associated with offline analytical testing can limit the speed of process development. Thus, developing and deploying analytical technology is necessary to accelerate process development. In this study, we have developed the micro sequential injection process analyzer and the automatic assay preparation platform system. These innovations address the unmet need for an automatic, online, real-time sample acquisition and preparation platform system for in-process monitoring, control, and release of biopharmaceuticals. These systems can also be deployed in laboratory areas as an offline analytical system and on the manufacturing floor to enable rapid testing and release of products manufactured in a good manufacturing practice environment.
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2024 |
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| Erschienen: |
2024 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:121 |
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| Enthalten in: |
Biotechnology and bioengineering - 121(2024), 4 vom: 29. Apr., Seite 1257-1270 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Wu, Chao-Hsiang Richard [VerfasserIn] |
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| Links: |
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| Themen: |
Automatic assay preparation platform (A2P2) |
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| Anmerkungen: |
Date Completed 01.04.2024 Date Revised 01.04.2024 published: Print-Electronic Citation Status MEDLINE |
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| doi: |
10.1002/bit.28649 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
NLM368180638 |
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| 520 | |a Enabling real-time monitoring and control of the biomanufacturing processes through product quality insights continues to be an area of focus in the biopharmaceutical industry. The goal is to manufacture products with the desired quality attributes. To realize this rigorous attribute-focused Quality by Design approach, it is critical to support the development of processes that consistently deliver high-quality products and facilitate product commercialization. Time delays associated with offline analytical testing can limit the speed of process development. Thus, developing and deploying analytical technology is necessary to accelerate process development. In this study, we have developed the micro sequential injection process analyzer and the automatic assay preparation platform system. These innovations address the unmet need for an automatic, online, real-time sample acquisition and preparation platform system for in-process monitoring, control, and release of biopharmaceuticals. These systems can also be deployed in laboratory areas as an offline analytical system and on the manufacturing floor to enable rapid testing and release of products manufactured in a good manufacturing practice environment | ||
| 650 | 4 | |a Journal Article | |
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| 650 | 4 | |a micro sequential injection (µSI) | |
| 650 | 4 | |a process analytical technology (PAT) | |
| 700 | 1 | |a Chan, Becky |e verfasserin |4 aut | |
| 700 | 1 | |a Sarich, Zac |e verfasserin |4 aut | |
| 700 | 1 | |a Duan, Yaokai |e verfasserin |4 aut | |
| 700 | 1 | |a Chen, Janice |e verfasserin |4 aut | |
| 700 | 1 | |a Song, Jiu-Li |e verfasserin |4 aut | |
| 700 | 1 | |a Berke, Mike |e verfasserin |4 aut | |
| 700 | 1 | |a Miranda, Les P |e verfasserin |4 aut | |
| 700 | 1 | |a Goudar, Chetan T |e verfasserin |4 aut | |
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