Biopharmaceutical Manufacturing: Historical Perspectives and Future Directions.

IF 7.6 2区工程技术 Q1 CHEMISTRY, APPLIED

Annual review of chemical and biomolecular engineering Pub Date : 2022-02-17 DOI:10.1146/annurev-chembioeng-092220-125832

Alana C Szkodny, Kelvin H Lee

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引用次数: 11

Abstract

This review describes key milestones related to the production of biopharmaceuticals-therapies manufactured using recombinant DNA technology. The market for biopharmaceuticals has grown significantly since the first biopharmaceutical approval in 1982, and the scientific maturity of the technologies used in their manufacturing processes has grown concomitantly. Early processes relied on established unit operations, with research focused on process scale-up and improved culture productivity. In the early 2000s, changes in regulatory frameworks and the introduction of Quality by Design emphasized the importance of developing manufacturing processes to deliver a desired product quality profile. As a result, companies adopted platform processes and focused on understanding the dynamic interplay between product quality and processing conditions. The consistent and reproducible manufacturing processes of today's biopharmaceutical industry have set high standards for product efficacy, quality, and safety, and as the industry continues to evolve in the coming decade, intensified processing capabilities for an expanded range of therapeutic modalities will likely become routine. Expected final online publication date for the Annual Review of Chemical and Biomolecular Engineering, Volume 13 is October 2022. Please see http://www.annualreviews.org/page/journal/pubdates for revised estimates.

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生物制药制造:历史展望与未来方向。

这篇综述描述了与使用重组DNA技术生产生物制药疗法相关的关键里程碑。自1982年第一个生物制药获批以来，生物制药市场已经显著增长，其制造过程中使用的技术的科学成熟度也随之提高。早期的工艺依赖于已建立的单元操作，研究重点是工艺放大和提高培养效率。在21世纪初，监管框架的变化和设计质量的引入强调了开发制造工艺以提供所需产品质量概况的重要性。因此，公司采用了平台流程，并专注于了解产品质量和加工条件之间的动态相互作用。当今生物制药行业的一致性和可重复性制造工艺为产品功效、质量和安全性设定了高标准，随着该行业在未来十年的不断发展，针对更广泛治疗方式的强化处理能力可能会成为常规。预计《化学与生物分子工程年度评论》第13卷的最终在线出版日期为2022年10月。修订后的估计数请参阅http://www.annualreviews.org/page/journal/pubdates。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Annual review of chemical and biomolecular engineering CHEMISTRY, APPLIED-ENGINEERING, CHEMICAL

CiteScore

16.00

自引率

0.00%

发文量

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.