Quality by Design characterization of the perfusion culture process for recombinant FVIII

Yong Jae Kim, Sang Hoon Paik, Sang Kyul Han, Sunggeun Lee, Yoomin Jeong, Ji youn Kim, Chan Wha Kim

Research output: Contribution to journalArticlepeer-review

6 Citations (Scopus)


A Quality by Design (QbD) concept was applied to characterize a cell culture process for production of the recombinant Factor VIII (rFVIII). We characterized the production bioreactor process and defined the design space by applying risk assessment to determine potential critical process parameters (CPPs) impacting critical quality attributes (CQAs). Characterization studies were subsequently performed using a qualified scaled-down model (SDM) and a multi-factorial design of experiment (DOE) approach to determine both the individual and combined impacts of the potential CPPs on CQAs. Among the operating parameters characterized, production temperature, production pH and a shift in the timing of production affected rFVIII activity and tyrosine sulfation level. Finally, we identified CPPs and established a design space for the cell culture process to identify appropriate conditions for routine manufacturing.

Original languageEnglish
Pages (from-to)37-46
Number of pages10
Publication statusPublished - 2019 May


  • Design space
  • Perfusion culture
  • Process characterization
  • Quality by Design (QbD)
  • Recombinant Factor FVIII

ASJC Scopus subject areas

  • Biotechnology
  • Bioengineering
  • Applied Microbiology and Biotechnology
  • Immunology and Microbiology(all)
  • Pharmacology


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