Process analytical technology (PAT) for biopharmaceuticals

Jarka Glassey, Krist Gernaey, Christoph Clemens, Torsten W. Schulz, Rui Oliveira, Gerald Striedner, Carl-Fredrik Mandenius

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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.
Original languageEnglish
JournalBiotechnology Journal
Volume6
Issue number4
Pages (from-to)369-377
ISSN1860-6768
DOIs
Publication statusPublished - 2011

Keywords

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

Cite this

Glassey, J., Gernaey, K., Clemens, C., Schulz, T. W., Oliveira, R., Striedner, G., & Mandenius, C-F. (2011). Process analytical technology (PAT) for biopharmaceuticals. Biotechnology Journal, 6(4), 369-377. https://doi.org/10.1002/biot.201000356