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一种实现可负担生物制品制造的一次性使用策略。

A Single-use Strategy to Enable Manufacturing of Affordable Biologics.

作者信息

Jacquemart Renaud, Vandersluis Melissa, Zhao Mochao, Sukhija Karan, Sidhu Navneet, Stout Jim

机构信息

Natrix Separations Inc., 5295 John Lucas Drive, Burlington, Ontario L7L 6A8, Canada.

出版信息

Comput Struct Biotechnol J. 2016 Jul 5;14:309-18. doi: 10.1016/j.csbj.2016.06.007. eCollection 2016.

DOI:10.1016/j.csbj.2016.06.007
PMID:27570613
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC4990569/
Abstract

The current processing paradigm of large manufacturing facilities dedicated to single product production is no longer an effective approach for best manufacturing practices. Increasing competition for new indications and the launch of biosimilars for the monoclonal antibody market have put pressure on manufacturers to produce at lower cost. Single-use technologies and continuous upstream processes have proven to be cost-efficient options to increase biomass production but as of today the adoption has been only minimal for the purification operations, partly due to concerns related to cost and scale-up. This review summarizes how a single-use holistic process and facility strategy can overcome scale limitations and enable cost-efficient manufacturing to support the growing demand for affordable biologics. Technologies enabling high productivity, right-sized, small footprint, continuous, and automated upstream and downstream operations are evaluated in order to propose a concept for the flexible facility of the future.

摘要

当前专门用于单一产品生产的大型制造设施的加工模式，已不再是实现最佳制造实践的有效方法。新适应症竞争的加剧以及单克隆抗体市场生物类似药的推出，给制造商带来了降低成本生产的压力。一次性技术和连续上游工艺已被证明是提高生物量产量的经济高效选择，但截至目前，这些技术在纯化操作中的应用还非常有限，部分原因是成本和放大生产方面的担忧。本综述总结了一次性整体工艺和设施策略如何能够克服规模限制，并实现经济高效的制造，以满足对价格合理的生物制品不断增长的需求。为了提出未来灵活设施的概念，对能够实现高生产率、尺寸合适、占地面积小、连续且自动化的上游和下游操作的技术进行了评估。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d337/4990569/9f18c5ceece8/gr3.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d337/4990569/bbd492c110d1/gr1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d337/4990569/f1623289536f/gr2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d337/4990569/9f18c5ceece8/gr3.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d337/4990569/bbd492c110d1/gr1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d337/4990569/f1623289536f/gr2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d337/4990569/9f18c5ceece8/gr3.jpg

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5
Development of purification processes for fully human bispecific antibodies based upon modification of protein A binding avidity.基于蛋白A结合亲和力修饰的全人源双特异性抗体纯化工艺的开发。
MAbs. 2016 May-Jun;8(4):828-38. doi: 10.1080/19420862.2016.1160192. Epub 2016 Mar 10.
6
Advance chromatin extraction improves capture performance of protein A affinity chromatography.改进的染色质提取方法可提高蛋白A亲和色谱的捕获性能。
J Chromatogr A. 2016 Jan 29;1431:1-7. doi: 10.1016/j.chroma.2015.12.044. Epub 2015 Dec 19.
7
At-line process analytical technology (PAT) for more efficient scale up of biopharmaceutical microfiltration unit operations.用于更高效扩大生物制药微滤单元操作规模的在线过程分析技术（PAT）。
Biotechnol Prog. 2016 Jan-Feb;32(1):108-15. doi: 10.1002/btpr.2193. Epub 2015 Nov 17.
8
Developing the biofacility of the future based on continuous processing and single-use technology.基于连续加工和一次性使用技术，开发未来的生物设施。
J Biotechnol. 2015 Nov 10;213:120-30. doi: 10.1016/j.jbiotec.2015.06.388. Epub 2015 Jun 16.
9
Advective hydrogel membrane chromatography for monoclonal antibody purification in bioprocessing.用于生物加工中单克隆抗体纯化的对流式水凝胶膜色谱法。
Biotechnol Prog. 2015 Jul-Aug;31(4):974-82. doi: 10.1002/btpr.2113. Epub 2015 Jun 14.
10
A new, integrated, continuous purification process template for monoclonal antibodies: Process modeling and cost of goods studies.一种用于单克隆抗体的新型、集成式连续纯化工艺模板：工艺建模与产品成本研究。
J Biotechnol. 2015 Nov 10;213:42-53. doi: 10.1016/j.jbiotec.2015.04.020. Epub 2015 May 8.