Towards a seamless product and process development workflow for recombinant proteins produced by plant molecular farming

IF 12.1 1区 工程技术 Q1 BIOTECHNOLOGY & APPLIED MICROBIOLOGY
J.F. Buyel
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引用次数: 0

Abstract

Plant molecular farming (PMF) has been promoted as a fast, efficient and cost-effective alternative to bacteria and animal cells for the production of biopharmaceutical proteins. Numerous plant species have been tested to produce a wide range of drug candidates. However, PMF generally lacks a systematic, streamlined and seamless workflow to continuously fill the product pipeline. Therefore, it is currently unable to compete with established platforms in terms of routine, throughput and horizontal integration (the rapid translation of product candidates to preclinical and clinical development). Individual management decisions, limited funding and a lack of qualified production capacity can hinder the execution of such projects, but we also lack suitable technologies for sample handling and data management. This perspectives article will highlight current bottlenecks in PMF and offer potential solutions that combine PMF with existing technologies to build an integrated facility of the future for product development, testing, manufacturing and clinical translation. Ten major bottlenecks have been identified and are discussed in turn: automated cloning and simplified transformation options, reproducibility of bacterial cultivation, bioreactor integration with automated cell handling, options for rapid mid-scale candidate and product manufacturing, interconnection with (group-specific or personalized) clinical trials, diversity of (post-)infiltration conditions, development of downstream processing platforms, continuous process operation, compliance of manufacturing conditions with biosafety regulations, scaling requirements for cascading biomass.

为植物分子农业生产的重组蛋白制定无缝的产品和工艺开发工作流程。
植物分子培养(PMF)已被推广为一种快速、高效和具有成本效益的生物制药蛋白质生产方法,可替代细菌和动物细胞。许多植物物种已通过测试,生产出多种候选药物。然而,PMF 通常缺乏系统、简化和无缝的工作流程,无法持续填充产品管道。因此,目前 PMF 无法在常规、产量和横向整合(将候选产品快速转化为临床前和临床开发)方面与成熟的平台竞争。个别的管理决策、有限的资金和缺乏合格的生产能力都会阻碍这些项目的实施,而且我们还缺乏合适的样本处理和数据管理技术。这篇视角独特的文章将重点介绍永磁同步加速器目前存在的瓶颈,并提供潜在的解决方案,将永磁同步加速器与现有技术相结合,打造一个集产品开发、测试、生产和临床转化于一体的未来设施。文章确定了十大瓶颈,并依次进行了讨论:自动克隆和简化转化选项、细菌培养的可重复性、生物反应器与自动细胞处理的集成、快速中型候选产品和产品生产选项、与(特定群体或个性化)临床试验的互联、(后)渗透条件的多样性、下游处理平台的开发、连续过程操作、生产条件与生物安全法规的一致性、级联生物质的扩展要求。
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
Biotechnology advances
Biotechnology advances 工程技术-生物工程与应用微生物
CiteScore
25.50
自引率
2.50%
发文量
167
审稿时长
37 days
期刊介绍: Biotechnology Advances is a comprehensive review journal that covers all aspects of the multidisciplinary field of biotechnology. The journal focuses on biotechnology principles and their applications in various industries, agriculture, medicine, environmental concerns, and regulatory issues. It publishes authoritative articles that highlight current developments and future trends in the field of biotechnology. The journal invites submissions of manuscripts that are relevant and appropriate. It targets a wide audience, including scientists, engineers, students, instructors, researchers, practitioners, managers, governments, and other stakeholders in the field. Additionally, special issues are published based on selected presentations from recent relevant conferences in collaboration with the organizations hosting those conferences.
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