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快速生物反应器过程优化和扩大生产麻疹载体COVID-19疫苗候选人的规模
David C Hesley1, Daniel Spatafore1, Jillian Shingler1
1Process Research & Development, Merck & Co., Inc., Rahway, New Jersey, USA.
Biotechnology progress
|February 6, 2025
概括
过程优化使得快速,大规模生产麻疹载体疫苗成为可能,这对抗疫情至关重要. 这些可扩展的方法支持未来的疫苗和细胞/基因疗法开发.
科学领域:
- 疫苗学 疫苗学 疫苗学
- 生物工艺工程 生物工艺工程
- 病毒载体技术 病毒载体技术
背景情况:
- 随着COVID-19的流行,疫苗的开发迅速成为必要,这凸显了敏捷制造工艺的必要性.
- 由于全球供应链紧张,传统的疫苗生产方法面临挑战.
研究的目的:
- 优化麻疹载体疫苗候选人V591的制造过程,以便快速大规模生产.
- 确定用于原材料采购,设备利用和媒体准备的灵活和可扩展的解决方案.
主要方法:
- 评估了玛辐射和热消毒的微载体,以扩大原材料选择.
- 实施一次性生物反应器,以减少实验的周转时间.
- 协调媒体配方与并行程序,以简化大规模的媒体准备.
主要成果:
- 在病毒种子交付六个月内成功展示了两个2000L制造规模的生物反应器.
- 建立了第一个能够满足高剂量流行病需求的大规模麻疹生产工艺.
- 为关键原材料和设备开发了可适应的工艺策略.
结论:
- 实施的流程优化策略使得快速扩展和大规模制造麻疹载体疫苗成为可能.
- 这些发现为未来的麻疹载体疫苗,瘤性麻疹菌株以及细胞和基因疗法的可扩展生产提供了有价值的框架.
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