不同强化上游工艺的比较,凸显药明康德超高生产率平台(WuXiUPTM)在提高产品质量和纯化率方面的优势。

IF 2.5 3区 生物学 Q3 BIOTECHNOLOGY & APPLIED MICROBIOLOGY Biotechnology Progress Pub Date : 2024-07-09 DOI:10.1002/btpr.3487
Xiang Zheng, Mingyue Fang, Yanling Zou, Shuo Wang, Weichang Zhou, Hang Zhou
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引用次数: 0

摘要

药明康德超高生产率平台(WuXiUPTM)是针对单克隆抗体、融合蛋白、双特异性抗体等多种生物制剂生产而开发的集约化、一体化连续生物工艺平台。该工艺技术平台在提高各种生物制剂的容积生产率方面表现出卓越的能力,并已用于大规模临床材料生产。本文从细胞生长、生产率和蛋白质质量的角度,讨论了采用药明康德和浓缩喂料批次(CFB)两种高产强化培养模式以及传统喂料批次(TFB)生产不同药物蛋白的案例研究。在体积生产率方面,药明康德和 CFB 均优于 TFB。此外,还发现了药明康德工艺在产品质量方面的独特优势,如减少了酸性电荷变异和碎片。因此,只需开发两个色谱步骤的简化下游纯化工艺,就能以令人满意的纯度和极高的收率提供目标产品。
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A comparison of different intensified upstream processes highlighting the advantage of WuXi Biologics' Ultra-high Productivity platform (WuXiUPTM) in improved product quality and purification yield.

WuXiUPTM, WuXi Biologics' Ultra-high Productivity platform, is an intensified and integrated continuous bioprocess platform developed for production of various biologics including monoclonal antibodies, fusion proteins, and bispecific antibodies. This process technology platform has manifested its remarkable capability in boosting the volumetric productivity of various biologics and has been implemented for large-scale clinical material productions. In this paper, case studies of the production of different pharmaceutical proteins using two high-producing and intensified culture modes of WuXiUPTM and the concentrated fed-batch (CFB), as well as the traditional fed-batch (TFB) are discussed from the perspectives of cell growth, productivity, and protein quality. Both WuXiUPTM and CFB outperformed TFB regarding volumetric productivity. Additionally, distinctive advantages in product quality profiles in the WuXiUPTM process, such as reduced acidic charge variants and fragmentation, are revealed. Therefore, a simplified downstream purification process with only two chromatographic steps can be developed to deliver the target product at a satisfactory purity and an extremely-high yield.

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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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