通过单用途技术实现生物制药制造的转型:现状、挑战和未来发展。

IF 7.6 2区 工程技术 Q1 CHEMISTRY, APPLIED Annual review of chemical and biomolecular engineering Pub Date : 2022-06-10 DOI:10.1146/annurev-chembioeng-092220-030223
Jasmin J. Samaras, M. Micheletti, W. Ding
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引用次数: 9

摘要

一次性使用技术已经改变了传统的生物制药生产,并且它们在抗体药物偶联物以及细胞和基因治疗产品等新兴应用中的应用正在迅速增加。在2019年冠状病毒大流行期间,这些颠覆性技术也产生了重大影响,有助于推动工艺开发,使新的单克隆抗体疗法和疫苗得以生产。一次性使用系统提供封闭的即插即用解决方案,并实现过程强化和连续处理。一些挑战仍然存在,为推进一次性传感器及其与一次性系统的集成,开发新型塑料材料以及标准化互换性设计提供了机会。由于行业变化迅速,需要对当前的一次性技术进行全面分析,总结材料科学的最新进展以及这些技术在端到端生物过程中的应用。
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Transformation of Biopharmaceutical Manufacturing Through Single-Use Technologies: Current State, Remaining Challenges, and Future Development.
Single-use technologies have transformed conventional biopharmaceutical manufacturing, and their adoption is increasing rapidly for emerging applications like antibody-drug conjugates and cell and gene therapy products. These disruptive technologies have also had a significant impact during the coronavirus disease 2019 pandemic, helping to advance process development to enable the manufacturing of new monoclonal antibody therapies and vaccines. Single-use systems provide closed plug-and-play solutions and enable process intensification and continuous processing. Several challenges remain, providing opportunities to advance single-use sensors and their integration with single-use systems, to develop novel plastic materials, and to standardize design for interchangeability. Because the industry is changing rapidly, a holistic analysis of the current single-use technologies is required, with a summary of the latest advancements in materials science and the implementation of these technologies in end-to-end bioprocesses.
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来源期刊
Annual review of chemical and biomolecular engineering
Annual review of chemical and biomolecular engineering CHEMISTRY, APPLIED-ENGINEERING, CHEMICAL
CiteScore
16.00
自引率
0.00%
发文量
25
期刊介绍: The Annual Review of Chemical and Biomolecular Engineering aims to provide a perspective on the broad field of chemical (and related) engineering. The journal draws from disciplines as diverse as biology, physics, and engineering, with development of chemical products and processes as the unifying theme.
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