Process analytical technology (PAT) for biopharmaceuticals

被引：142

作者：

Glassey, Jarka ^{[1
]}

Gernaey, Krist V. ^{[2
]}

Clemens, Christoph ^{[3
]}

Schulz, Torsten W. ^{[3
]}

Oliveira, Rui ^{[4
,5
]}

Striedner, Gerald ^{[6
]}

Mandenius, Carl-Fredrik ^{[7
]}

机构：

[1] Newcastle Univ, Sch Chem Engn & Adv Mat, Newcastle Upon Tyne NE1 7RU, Tyne & Wear, England

[2] Tech Univ Denmark, Dept Chem & Biochem Engn, Ctr Proc Engn & Technol, Lyngby, Denmark

[3] Boehringer Ingelheim Pharma GmbH & Co KG, Ingelheim, Germany

[4] FCT Univ Nova Lisboa, Dept Chem, Lisbon, Portugal

[5] Inst Biol Expt & Tecnol, Oeiras, Portugal

[6] Univ Nat Resources & Appl Life Sci, Dept Biotechnol, Vienna, Austria

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

来源：

BIOTECHNOLOGY JOURNAL | 2011年 / 6卷 / 04期

关键词：

CHO cells; Critical quality attributes; E; coli; Fed-batch process; Process analytical technology; COLI EXPRESSION SYSTEMS; SENSITIVITY-ANALYSIS; RECOMBINANT PROTEIN; SIMULATION; STRATEGIES; BIOLOGY; FERMENTATION; PRODUCTIVITY; FLUORESCENCE; MANUFACTURE;

D O I：

10.1002/biot.201000356

中图分类号：

Q5 [生物化学];

学科分类号：

071010 ; 081704 ;

摘要：

Process analytical technology (PAT), the regulatory initiative for building in quality to pharmaceutical manufacturing, has a great potential for improving biopharmaceutical production. The recommended analytical tools for building in quality, multivariate data analysis, mechanistic modeling, novel models for interpretation of systems biology data and new sensor technologies for cellular states, are instrumental in exploiting this potential. Industrial biopharmaceutical production has gradually become dependent on large-scale processes using sensitive mammalian cell cultures. This further emphasizes the need for improved PAT solutions. We summarize recent progress in this area based on an expert workshop held at the 8(th) European Symposium on Biochemical Engineering Sciences (Bologna, 2010), and highlight new opportunities for exploiting PAT when applied in biopharmaceutical production. We conclude with recommendations for advancing PAT applications in the biopharmaceutical industry.

引用

页码：369 / 377

页数：9

共 45 条

[41] Hybrid semi-parametric mathematical systems: Bridging the gap between systems biology and process engineering [J].