オーラルセッション
- 第3日 5月13日（水） 15:10～15:30 B会場（1202）
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3B-O14-1510 PDF
UPLC/MSによるアデノ随伴ウイルス（AAV）ベクターの特性解析
Adeno-associated viruses (AAVs) have become the most widely used vectors in gene therapy development for their low toxicity and long-term expression ability. To ensure the safety and quality of gene therapy products, the critical quality attributes (CQAs) of AAVs must be well understood and monitored throughout the product development process. While conventional analytical methods such as analytical ultra-centrifugation (AUC) and SDS-PAGE can provide valuable information regarding the CQAs of AAVs, the results are often laborious to acquire and difficult to validate. Here, we report the development of LC and MS based methods for comprehensive characterization of AAV capsids in order to deliver efficient, accurate, and reproducible measurement of CQAs including capsid protein stoichiometry and modifications, aggregation, and empty/full ratio.