最近在上游工艺开发方面取得的进展,用于生产复合腺相关病毒
Jianfa Ou1, Yawen Tang1, Jianlin Xu1
1Biologics Development, Global Product Development and Supply, Bristol Myers Squibb, Devens, Massachusetts, USA.
Biotechnology and bioengineering
|September 11, 2023
概括
复合腺相关病毒 (rAAV) 生产在扩大基因疗法的制造方面面临挑战. 本综述探讨了上游流程优化,以提高rAAV生产效率并满足市场需求.
科学领域:
- 生物技术是生物技术.
- 基因治疗制造业 基因治疗制造业
- 病毒载体生产病毒载体生产
背景情况:
- 再组合腺相关病毒 (rAAV) 由于其安全性和有效性,是基因疗法的领先输送工具.
- 在扩大rAAV生产以满足市场需求和当前制造过程的复杂性方面存在重大挑战.
研究的目的:
- 审查目前的rAAV上游制造流程.
- 确定并提出优化方案,以提高rAAV生产能力.
- 为弥补生产能力和对基因疗法的潜在市场需求之间的差距.
主要方法:
- 对rAAV上游制造的当前文献的综述.
- 分析RAAV生产介质和细胞培养开发方面的进展.
- 遗传元素传递方法,培养容器选择和过程控制策略的总结.
主要成果:
- 确定了优化rAAV生产的关键领域,包括媒体开发和遗传元素交付.
- 根据生产特点,概述了培养器选择的标准.
- 强调了解生产动力学和质量控制对于流程优化的重要性.
结论:
- 优化上游流程对于高效且可扩展的rAAV制造至关重要.
- 媒体,交付方法和过程控制方面的进步可以加速开发并提高生产产量.
- 应对生产挑战将促进基于rAAV的基因疗法的更广泛应用.
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