Mini-review: soft sensors as means for PAT in the manufacture of bio-therapeutics

被引：59

作者：

Mandenius, Carl-Fredrik ^{[1
]}

Gustavsson, Robert ^{[1
]}

机构：

[1] Linkoping Univ, Div Biotechnol, IFM, S-58183 Linkoping, Sweden

来源：

JOURNAL OF CHEMICAL TECHNOLOGY AND BIOTECHNOLOGY | 2015年 / 90卷 / 02期

关键词：

Bioprocesses; Bioreactors; Monitoring; Process Control; NEAR-INFRARED SPECTROSCOPY; SURFACE-PLASMON RESONANCE; ANALYTICAL TECHNOLOGY PAT; AUTOMATED FLOW-CYTOMETRY; FED-BATCH CULTIVATION; REAL-TIME ESTIMATION; MASS-SPECTROMETRY; ONLINE ESTIMATION; CELL-CULTURE; ELECTRONIC NOSE;

D O I：

10.1002/jctb.4477

中图分类号：

Q81 [生物工程学（生物技术）]; Q93 [微生物学];

学科分类号：

071005 ; 0836 ; 090102 ; 100705 ;

摘要：

This mini-review discusses how soft sensors can contribute to accomplish FDA's process analytical technology (PAT) ambitions in the manufacture of bio-therapeutics. Focus is on applications with protein-based drugs (proteins, antibodies), but also gene therapy vectors as well as cell cultures are considered where chemical and bio-analytical as well as mathematical and statistical methods are used as tools. An overview of existing soft sensor alternatives and how these can be configured to meet typical industrial needs is provided. It is noted how several of these needs coincide with the PAT regulatory incentives but do also address process economic aspects of bio-therapeutic manufacture. Evaluation of soft sensor alternatives is highlighted in relation to the production targets, quality attributes and the specification of these as well as shortcomings and needs for further improvements. (c) 2014 Society of Chemical Industry

引用

页码：215 / 227

页数：13

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