Prediction models for the flux decay profile and initial flux of microfiltration for therapeutic proteins

Inoue, Kota; Masuda, Yumiko; Torisu, Tetsuo et al.

Biotechnology and Bioengineering, 2024, 121(6), 1889-1901

Number of Access:708（2025-08-14 12:00 Counts）

Identifier to cite or link to this item: https://hdl.handle.net/11094/95748

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Title
Prediction models for the flux decay profile and initial flux of microfiltration for therapeutic proteins
Creator
CreatorName
Inoue, Kota
CreatorName
Masuda, Yumiko
NRID
1000010730492 1000010730492
ORCID
0000-0002-8269-7803 0000-0002-8269-7803
researchmap permalink
torisutetsuo torisutetsuo
Scopus Author ID
57361287600 57361287600
CreatorName
Torisu, Tetsuo
CreatorName
Nonaka, Koichi
NRID
1000090335381 1000090335381
ORCID
0000-0002-5181-179X 0000-0002-5181-179X
researchmap permalink
read0090387 read0090387
Scopus Author ID
35429790100 35429790100
CreatorName
Uchiyama, Susumu
Subject
filter fouling
flux decay
initial flux
microfiltration
prediction model
protein aggregates
Description
Inoue K., Masuda Y., Torisu T., et al. Prediction models for the flux decay profile and initial flux of microfiltration for therapeutic proteins. Biotechnology and Bioengineering , (2024); https://doi.org/10.1002/bit.28692.
Abstract
Microfiltration (MF) is an essential step during biopharmaceutical manufacturing. However, unexpected flux decay can occur. Although the flux decay profile and initial flux are important factors determining MF filterability, predicting them accurately is challenging, as the root cause of unexpected flux decay remains elusive. In this study, the methodology for developing a prediction model of flux decay profiles was established. First, the filtration profiles of different monodisperse polystyrene latex and silica beads of various sizes were evaluated. These results revealed that the size and surface electrostatic properties of the beads affect the flux decay profile. Taking the size and surface electrostatic properties of protein aggregates into account, we constructed a predictive model using model bead filtration profiles. We showed that this methodology was applicable to two different MF filters to predict the flux decay profile of therapeutic proteins. Because our proposed prediction model is based on normalized flux, the initial flux is required to predict the overall filtration profile. Then, we applied the Hagen–Poiseuille equation using sample viscosity values to estimate the initial flux. The developed prediction models can be used for effective MF scale-up assessment during the early stages of process development.
Publisher
John Wiley and Sons Inc
Source Title
Biotechnology and Bioengineering
Volume (Issue)
121(6)
Page
1889-1901
Date of Issued
2024-06-01
Language
English
Handle URL
https://hdl.handle.net/11094/95748
PISSN
00063592
eISSN
10970290
Relation.isIdenticalTo
DOI (Publisher Version)
https://doi.org/10.1002/bit.28692
Access Rights
open access
CopyRight
This article is licensed under a Creative Commons Attribution 4.0 International License.
oaire:version
Version of Record
Category
学術雑誌論文 Journal Article