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Process analytical technology (PAT) for biopharmaceuticals
Newcastle University.
Technical University Denmark.
Boehringer Ingelheim Pharma GmbH and Co KG.
Boehringer Ingelheim Pharma GmbH and Co KG.
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2011 (English)In: BIOTECHNOLOGY JOURNAL, ISSN 1860-6768, Vol. 6, no 4, 369-377 p.Article in journal (Refereed) Published
Abstract [en]

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.

Place, publisher, year, edition, pages
WILEY-BLACKWELL, COMMERCE PLACE, 350 MAIN ST, MALDEN 02148, MA USA , 2011. Vol. 6, no 4, 369-377 p.
Keyword [en]
CHO cells, Critical quality attributes, E. coli, Fed-batch process, Process analytical technology
National Category
Engineering and Technology
URN: urn:nbn:se:liu:diva-67736DOI: 10.1002/biot.201000356ISI: 000289214500002OAI: diva2:412634
Available from: 2011-04-26 Created: 2011-04-26 Last updated: 2011-04-26

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Mandenius, Carl-Fredrik
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Biotechnology The Institute of Technology
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