期刊
BIOTECHNOLOGY AND BIOENGINEERING
卷 117, 期 10, 页码 3199-3211出版社
WILEY
DOI: 10.1002/bit.27472
关键词
adeno-associated virus (AAV); downstream; gene therapy; purification; quality by design (QbD)
In recent years, there has been a strong interest in the development and production of gene therapy products, especially those utilizing adeno-associated virus (AAV) particles. This is evident with the growing number of clinical successes and agency approvals for AAV therapeutics. Due to this increased investment in this technology, a need exists for scalable commercial production methods to ensure adequate product supply as research in AAV shifts from bench-scale development to clinical production. The purpose of this review is to summarize current scalable purification techniques that can be employed during the commercial manufacturing of AAV as well as highlight certain development considerations, such as adventitious agent removal and process development using the principals of quality by design.
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