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对病毒产品的批量和连续水性双相净化经济模拟
Natalie M Nold1,2, Eric Pearson1, Caryn L Heldt1,2
1Department of Chemical Engineering, Michigan Technological University, Houghton, Michigan, USA.
Biotechnology progress
|October 16, 2023
概括
水性双相系统 (ATPS) 为病毒载体净化提供了具有成本效益的替代方案,大大降低了制造成本并改善了疫苗的可访问性. 使用ATPS进行连续处理,有望降低疫苗生产的资本和运营成本.
科学领域:
- 生物技术是生物技术.
- 工艺工程的过程工程.
- 疫苗学 疫苗学 疫苗学
背景情况:
- 疫苗制造成本影响全球接入和本地化生产能力.
- 连续加工为生物制造提供了潜在的成本降低.
- 水性双相系统 (ATPS) 是一种适用于连续病毒载体处理的液体-液体提取技术.
研究的目的:
- 为了经济地比较传统的基于染色体的病毒净化与基于ATPS的净化.
- 在批量和连续模式中评估ATPS用于病毒载体净化.
- 评估尺度对ATPS与染色学相比的成本效益的影响.
主要方法:
- 开发了经济模拟,并与现有的病毒子单位制造模型进行了验证.
- 模拟了ATPS净化的资本和运营成本,并将其与各种规模的传统染色学相比较.
- 分析了批量和连续ATPS配置的成本效益.
主要成果:
- 与所有尺度的染色体相比,ATPS净化需要不到10%的资本支出.
- 在11公斤/年尺度上,ATPS的生产成本比染色学低50%.
- 连续ATPS工厂建设成本可能低于11公斤/年规模的批量ATPS的一半.
结论:
- 基于ATPS的净化提供了一个重要的机会,可以降低疫苗行业的制造成本.
- 在各种生产规模上,ATPS的经济效益显而易见,特别是在连续加工领域.
- 对替代色谱配置的进一步调查可能会提高ATPS的成本效益,尽管纯度和回收需要实验验证.
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