细胞治疗产品生产中的生物工艺自动化:特别兴趣小组自动化研讨会的成果。

Bioprocessing automation in cell therapy manufacturing: Outcomes of special interest group automation workshop.

机构信息

Biolacuna, Oxford, UK.

Biolacuna, Oxford, UK.

出版信息

Cytotherapy. 2018 Apr;20(4):592-599. doi: 10.1016/j.jcyt.2018.01.005. Epub 2018 Feb 13.

Abstract

Phacilitate held a Special Interest Group workshop event in Edinburgh, UK, in May 2017. The event brought together leading stakeholders in the cell therapy bioprocessing field to identify present and future challenges and propose potential solutions to automation in cell therapy bioprocessing. Here, we review and summarize discussions from the event. Deep biological understanding of a product, its mechanism of action and indication pathogenesis underpin many factors relating to bioprocessing and automation. To fully exploit the opportunities of bioprocess automation, therapeutics developers must closely consider whether an automation strategy is applicable, how to design an 'automatable' bioprocess and how to implement process modifications with minimal disruption. Major decisions around bioprocess automation strategy should involve all relevant stakeholders; communication between technical and business strategy decision-makers is of particular importance. Developers should leverage automation to implement in-process testing, in turn applicable to process optimization, quality assurance (QA)/ quality control (QC), batch failure control, adaptive manufacturing and regulatory demands, but a lack of precedent and technical opportunities can complicate such efforts. Sparse standardization across product characterization, hardware components and software platforms is perceived to complicate efforts to implement automation. The use of advanced algorithmic approaches such as machine learning may have application to bioprocess and supply chain optimization. Automation can substantially de-risk the wider supply chain, including tracking and traceability, cryopreservation and thawing and logistics. The regulatory implications of automation are currently unclear because few hardware options exist and novel solutions require case-by-case validation, but automation can present attractive regulatory incentives.

摘要

Phacilitate 于 2017 年 5 月在英国爱丁堡举办了一场特别利益集团研讨会活动。该活动聚集了细胞治疗生物加工领域的主要利益相关者,旨在确定当前和未来的挑战,并提出细胞治疗生物加工自动化的潜在解决方案。在此,我们回顾并总结了活动中的讨论。对产品的深入生物学理解、其作用机制和适应症发病机制是与生物加工和自动化相关的许多因素的基础。为了充分利用生物加工自动化的机会,治疗药物开发者必须仔细考虑自动化策略是否适用,如何设计“可自动化”的生物加工过程,以及如何在最小干扰的情况下进行工艺修改。生物加工自动化策略的主要决策应涉及所有相关利益相关者;技术和商业战略决策者之间的沟通尤为重要。开发者应该利用自动化来实施过程中的测试,进而适用于工艺优化、质量保证 (QA)/质量控制 (QC)、批次故障控制、适应性制造和监管需求,但缺乏先例和技术机会可能会使这些努力变得复杂。产品特性、硬件组件和软件平台的标准化程度参差不齐,被认为使自动化的实施变得复杂。先进算法方法(如机器学习)的使用可能适用于生物加工和供应链优化。自动化可以大大降低更广泛的供应链风险,包括跟踪和可追溯性、冷冻保存和解冻以及物流。自动化的监管影响目前尚不清楚,因为硬件选项很少,并且需要逐个案例验证新的解决方案,但自动化可以带来有吸引力的监管激励。

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