在 Ambr® 250 HT 中开发用于质粒 DNA 发酵过程的高通量缩小模型。

IF 2.5 3区 生物学 Q3 BIOTECHNOLOGY & APPLIED MICROBIOLOGY Biotechnology Progress Pub Date : 2024-03-18 DOI:10.1002/btpr.3458
Shu Fang, Dillon J. Sinanan, Marc H. Perez, Raúl G. Cruz-Quintero, Sachin R. Jadhav
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引用次数: 0

摘要

信使核糖核酸 (mRNA) 疫苗和基因治疗载体的最新进展增加了生物制药行业对快速质粒 DNA (pDNA) 筛选和生产的需求。与传统的台式玻璃发酵罐或小规模就地蒸汽(SIP)发酵罐相比,高通量(HT)发酵罐系统(如 Ambr® 250 HT)可显著加快 pDNA 上游工艺的流程开发时间。然而,与传统的小规模模型类似,这种缩小模型必须经过鉴定,以确保它们能代表更大规模的工艺。在目前的研究中,我们利用三个细胞系生产三种不同的构建体,在 Ambr® 250 HT 发酵罐中开发了一个具有代表性的 Biostat® D-DCU 30 L pDNA 发酵过程缩小模型。Ambr 缩小模型的工艺性能和 pDNA 质量与 30 L SIP 发酵工艺相当。此外,我们还通过双向鉴定证明了 Ambr 模型的预测价值,首先是准确再现了在 30 升工艺中观察到的先前趋势,然后预测了新的工艺趋势,这些趋势随后在 30 升工艺中成功再现。本研究中开发的具有代表性和预测性的缩比 Ambr 模型将为菌株/克隆/宿主细胞筛选、pDNA 工艺开发和表征研究、工艺放大研究和生产支持提供更快、更高效的方法。
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Development of a high-throughput scale-down model in Ambr® 250 HT for plasmid DNA fermentation processes

Recent advances in messenger ribonucleic acid (mRNA) vaccines and gene therapy vectors have increased the need for rapid plasmid DNA (pDNA) screening and production within the biopharmaceutical industry. High-throughput (HT) fermentor systems, such as the Ambr® 250 HT, can significantly accelerate process development timelines of pDNA upstream processes compared to traditional bench-scale glass fermentors or small-scale steam-in-place (SIP) fermentors. However, such scale-down models must be qualified to ensure that they are representative of the larger scale process similar to traditional small-scale models. In the current study, we developed a representative scale-down model of a Biostat® D-DCU 30 L pDNA fermentation process in Ambr® 250 HT fermentors using three cell lines producing three different constructs. The Ambr scale-down model provided comparable process performance and pDNA quality as the 30 L SIP fermentation process. In addition, we demonstrated the predictive value of the Ambr model by two-way qualification, first by accurately reproducing the prior trends observed in a 30 L process, followed by predicting new process trends that were then successfully reproduced in the 30 L process. The representative and predictive scale-down Ambr model developed in this study would enable a faster and more efficient approach to strain/clone/host-cell screening, pDNA process development and characterization studies, process scale-up studies, and manufacturing support.

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来源期刊
Biotechnology Progress
Biotechnology Progress 工程技术-生物工程与应用微生物
CiteScore
6.50
自引率
3.40%
发文量
83
审稿时长
4 months
期刊介绍: Biotechnology Progress , an official, bimonthly publication of the American Institute of Chemical Engineers and its technological community, the Society for Biological Engineering, features peer-reviewed research articles, reviews, and descriptions of emerging techniques for the development and design of new processes, products, and devices for the biotechnology, biopharmaceutical and bioprocess industries. Widespread interest includes application of biological and engineering principles in fields such as applied cellular physiology and metabolic engineering, biocatalysis and bioreactor design, bioseparations and downstream processing, cell culture and tissue engineering, biosensors and process control, bioinformatics and systems biology, biomaterials and artificial organs, stem cell biology and genetics, and plant biology and food science. Manuscripts concerning the design of related processes, products, or devices are also encouraged. Four types of manuscripts are printed in the Journal: Research Papers, Topical or Review Papers, Letters to the Editor, and R & D Notes.
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