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| Hauptverfasser: | , , , , , , |
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| Format: | Artículo Open Access |
| Veröffentlicht: |
Wiley
2025
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| Schlagworte: | |
| Online-Zugang: | https://analyticalsciencejournals.onlinelibrary.wiley.com/doi/10.1002/bit.70052 |
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Inhaltsangabe:
- Accelerated Adeno Associated Virus Upstream Process Development From High‐Throughput Systems to Clinical Scale Angela Andaluz Brittany Monteverde Kevin Vera Brandon Tse Ivan Gajic Clifford Froelich Seyed Pouria Motevalian Biotechnology and Bioengineering ABSTRACT Adeno‐associated virus (AAV) is one of the most common delivery systems used in gene therapy. Challenges in the development and manufacturing of AAVs include high cost of goods (COGs) per dose, process scalability, speed to market, and process‐related impurities such as empty capsids. This article presents a streamlined approach to developing and scaling AAV upstream production process via triple transfection from bench scale to commercial volumes exceeding 1,000 L. By leveraging high‐throughput technologies such as the AMBR®15 system, we achieved rapid upstream process development in under 2 months. These tools enabled optimization of productivity, impurity reduction, and COGs per dose. We also detail methodologies for direct scale‐up from AMBR®15 to a 2,000 L single‐use production bioreactor. 10.1002/bit.70052 http://creativecommons.org/licenses/by-nc-nd/4.0/