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Process analytical technology (PAT) for biopharmaceuticals

Lookup NU author(s): Professor Jarka Glassey

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Abstract

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.


Publication metadata

Author(s): Glassey J, Gernaey KV, Clemens C, Schulz TW, Oliveira R, Striedner G, Mandenius CF

Publication type: Article

Publication status: Published

Journal: Biotechnology Journal

Year: 2011

Volume: 6

Issue: 4

Pages: 369-377

Print publication date: 18/03/2011

ISSN (print): 1860-6768

ISSN (electronic): 1860-7314

Publisher: Wiley - VCH Verlag GmbH & Co. KGaA

URL: http://dx.doi.org/10.1002/biot.201000356

DOI: 10.1002/biot.201000356


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