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• W3048151498 abstract "The development of gene therapy products has been expanding globally, and among them, the recombinant adeno-associated virus (rAAV) vector is one of the most promising vectors for gene transfer. For efficient and rapid development of the manufacturing process and quality control strategy, the quality by design (QbD) approach can be as effective for gene therapy products as it is for gene recombinant proteins, which have been developed for decades. However, prior available knowledge required for the QbD approach is limited in the field of gene therapy. Here, we comprehensively review rAAV study results that can form the basis of QbD-based development and propose a critical quality attribute identification method suitable for gene therapy development. As a case study for rAAV, we propose a series of practical development steps, including a quality target product profile (QTPP) setting, identification of critical quality attributes (CQAs), repetitive risk assessment associated with process optimization, design space (DS) establishment, and control strategy using the QbD method. Our case study, which was based on publicly available literature, is a basic model that can be augmented by unique data pertaining to specific products. An improvement in rAAV development is expected using this model as the first step." @default.
• W3048151498 created "2020-08-13" @default.
• W3048151498 creator A5000889450 @default.
• W3048151498 creator A5026999790 @default.
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• W3048151498 date "2020-10-01" @default.
• W3048151498 modified "2023-09-27" @default.
• W3048151498 title "Optimization of the quality by design approach for gene therapy products: A case study for adeno-associated viral vectors" @default.
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• W3048151498 doi "https://doi.org/10.1016/j.ejpb.2020.08.002" @default.
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