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Trends in Biotechnology
Volume 41 (10), 2023, Pages 1268-1281

Challenges in scaling up AAV-based gene therapy manufacturing

Ziyu Jiang1, Paul A. Dalby1

Department of Biochemical Engineering, University College London, Gower Street, London WC1E 6BT, UK.


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.

Keywords: adeno-associated virus, gene therapy, quality by design, scale down, manufacturing.

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