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在Ambr® 250 HT中开发一个高通量缩放模型,用于等离子体DNA发酵过程

Shu Fang¹, Dillon J Sinanan¹, Marc H Perez¹

¹BioProcess Research & Development, Pfizer Inc., Chesterfield, Missouri, USA.

Biotechnology progress

|March 18, 2024

概括

使用Ambr® 250 HT发酵器的新缩小模型准确地表示和预测等离子体DNA (pDNA) 发酵过程. 这加快了生物制药开发和制造的速度,使得查和流程优化更快.

科学领域:

生物技术是生物技术.
生物工艺工程生物工艺工程
分子生物学分子生物学

背景情况:

在mRNA疫苗和基因治疗方面的进步增加了对快速等离子体DNA (pDNA) 生产的需求.
像Ambr® 250 HT这样的高通量 (HT) 发酵器系统为pDNA上游过程提供了加速的过程开发.
缩小模型需要资格,以确保它们准确地反映了更大规模的生物过程.

研究的目的:

使用Ambr® 250 HT系统开发和资格化一个代表性的塑体DNA发酵缩小模型.
评估模型复制和预测更大规模发酵性能和产品质量的能力.
验证该模型对菌株/克隆查,过程开发和扩展的实用性.

主要方法:

在Ambr® 250 HT发酵器中开发了一个缩小模型,用于30L Biostat® D-DCU等离子体DNA发酵过程.
用了三个不同的细胞系和结构来进行模型开发和验证.
采用双向资格策略,包括复制以前的趋势和预测新的趋势.

主要成果:

安布尔® 250 HT缩小模型的工艺性能和等离子体DNA质量与30 L参考工艺相比,具有可比性.
该模型成功地重现了在更大规模上观察到的历史过程趋势.
该模型准确地预测了新的过程趋势,这些趋势随后在30L发酵器中得到了验证.

结论:

开发的Ambr® 250 HT模型是等离子体DNA发酵的代表性和预测性缩放工具.
这种经过验证的模型促进了更快,更有效的菌株/克隆查和过程开发.
该模型支持改进的工艺扩展研究和用于塑体DNA生产的制造操作.

关键词:

阿姆布尔 250 HT 250 HT 的产品.塑体发酵的发酵过程发展过程发展过程.缩小规模的下降模型.菌株查菌株查菌株查

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