A Single-use Strategy to Enable Manufacturing of Affordable Biologics

被引：68

作者：

Jacquemart, Renaud ^{[1
]}

Vandersluis, Melissa ^{[1
]}

Zhao, Mochao ^{[1
]}

Sukhija, Karan ^{[1
]}

Sidhu, Navneet ^{[1
]}

Stout, Jim ^{[1
]}

机构：

[1] Natrix Separat Inc, 5295 John Lucas Dr, Burlington, ON L7L 6A8, Canada

来源：

COMPUTATIONAL AND STRUCTURAL BIOTECHNOLOGY JOURNAL | 2016年 / 14卷

关键词：

Flexible; single-use facilities; Continuous bioprocessing; Antibody manufacturing paradigms; Process economics; Affinity membrane chromatography; ANTIBODY; PURIFICATION; TECHNOLOGY; BIOREACTOR; EQUIPMENT; FUTURE; CELLS; COST;

D O I：

10.1016/j.csbj.2016.06.007

中图分类号：

Q5 [生物化学]; Q7 [分子生物学];

学科分类号：

071010 ; 081704 ;

摘要：

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. (C) 2016 Natrix Separations. Published by Elsevier B.V. on behalf of Research Network of Computational and Structural Biotechnology.

引用

页码：309 / 318

页数：10

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