Jiang, Z;
Dalby, PA;
(2023)
Challenges in scaling up AAV-based gene therapy manufacturing.
Trends in Biotechnology
, 41
(10)
pp. 1268-1281.
10.1016/j.tibtech.2023.04.002.
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Abstract
Accelerating the scale up of adeno-associated virus (AAV) manufacture is highly desirable to meet the increased demand for gene therapies. However, the development of bioprocesses for AAV gene therapies remains time-consuming and challenging. The quality by design (QbD) approach ensures bioprocess designs that meet the desired product quality and safety profile. Rapid stress tests, developability screens, and scale-down technologies have the potential to streamline AAV product and manufacturing bioprocess development within the QbD framework. Here we review how their successful use for antibody manufacture development is translating to AAV, but also how this will depend critically on improved analytical methods and adaptation of the tools as more understanding is gained on the critical attributes of AAV required for successful therapy.
| Type: | Article |
|---|---|
| Title: | Challenges in scaling up AAV-based gene therapy manufacturing |
| Location: | England |
| Open access status: | An open access version is available from UCL Discovery |
| DOI: | 10.1016/j.tibtech.2023.04.002 |
| Publisher version: | https://doi.org/10.1016/j.tibtech.2023.04.002 |
| Language: | English |
| Additional information: | © 2023 The Authors. Published by Elsevier Ltd. This is an open access article under the CC BY license (http://creativecommons.org/licenses/by/4.0/). |
| Keywords: | Adeno-associated virus, gene therapy, manufacturing, quality by design, scale down |
| UCL classification: | UCL UCL > Provost and Vice Provost Offices > UCL BEAMS UCL > Provost and Vice Provost Offices > UCL BEAMS > Faculty of Engineering Science UCL > Provost and Vice Provost Offices > UCL BEAMS > Faculty of Engineering Science > Dept of Biochemical Engineering UCL > Provost and Vice Provost Offices > UCL BEAMS > Faculty of Engineering Science > Engineering Science Faculty Office |
| URI: | https://discovery.ucl.ac.uk/id/eprint/10169666 |
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