Process analytical technology (PAT) for biopharmaceuticals

Publication: Research - peer-reviewJournal article – Annual report year: 2011

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  • Author: Glassey, Jarka

    University of Newcastle, School of Chemical Engineering and Advanced Materials

  • Author: Gernaey, Krist

    Department of Chemical and Biochemical Engineering, Technical University of Denmark, Søltofts Plads, 2800, Kgs. Lyngby, Denmark

  • Author: Clemens, Christoph

    Boehringer Ingelheim Pharma GmbH & Co. KG

  • Author: Schulz, Torsten W.

    Boehringer Ingelheim Pharma GmbH & Co. KG

  • Author: Oliveira, Rui

    FCT/Universidade Nova de Lisboa, Chemistry Department

  • Author: Striedner, Gerald

    University of Natural Resources and Applied Life Sciences, Vienna

  • Author: Mandenius, Carl-Fredrik

    Linköping University

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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.
Original languageEnglish
JournalBiotechnology Journal
Publication date2011
Volume6
Issue4
Pages369-377
ISSN1860-6768
DOIs
StatePublished
CitationsWeb of Science® Times Cited: 20

Keywords

  • Fed-batch process, CHO cells, E. coli, Process analytical technology, Critical quality attributes
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