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Evaluating and modeling the impacts of mixed-mode and surface-modified column chromatography on virus filtration performance
  • Hironobu Shirataki,
  • Yoshiro Yokoyama,
  • Ryota Oguri
Hironobu Shirataki
Asahi Kasei Medical Co Ltd
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Yoshiro Yokoyama
Asahi Kasei Medical Co Ltd Nobeoka Area Okatomi Plant
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Ryota Oguri
Asahi Kasei Medical Co Ltd Nobeoka Area Okatomi Plant
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Abstract

Virus filtration is a critical process in the production of biotherapeutics and drug products derived by plasma fractionation. The filterability of process solutions on virus removal filters is largely dependent on preceding downstream process steps, and column chromatography can have a particularly large impact on the throughput and flux of virus filtration. Filterability (throughput and flux) on Planova BioEX was greatly reduced for mAb and plasma IgG spiked with aggregate, and filterability improvement achieved by processing with chromatography resins (modified CEX, mixed-mode AEX and normal AEX column) was specific to protein solution. The various protein solutions spiked with aggregate showed distinct solution characteristics and by using the resulting filtration volume and flow rate, experimental and calculated filtration parameters were compared and evaluated with four clogging models: cake filtration, intermediate blocking, standard blocking and complete blocking. Effective purification of feed solutions by column chromatography has the capability to improve virus filtration processes. Further, the application of filtration parameters to the appropriate clogging model makes it possible to extrapolate filtration behavior to larger processing volumes.

Peer review status:UNDER REVIEW

24 Sep 2020Submitted to Biotechnology and Bioengineering
24 Sep 2020Assigned to Editor
24 Sep 2020Submission Checks Completed
02 Oct 2020Reviewer(s) Assigned
19 Oct 2020Review(s) Completed, Editorial Evaluation Pending