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

Inoue, Kota; Masuda, Yumiko; Torisu, Tetsuo; Nonaka, Koichi; Uchiyama, Susumu

doi:https://doi.org/10.1002/bit.28692

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

アクセス数:689件（2025-07-27 09:15 集計）

固定URL: https://hdl.handle.net/11094/95748

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タイトル	Prediction models for the flux decay profile and initial flux of microfiltration for therapeutic proteins
著者	著者名 Inoue, Kota
	著者名 Masuda, Yumiko
	NRID 1000010730492 1000010730492 ORCID 0000-0002-8269-7803 0000-0002-8269-7803 researchmap permalink torisutetsuo torisutetsuo Scopus Author ID 57361287600 57361287600 著者名 Torisu, Tetsuo
	著者名 Nonaka, Koichi
	NRID 1000090335381 1000090335381 ORCID 0000-0002-5181-179X 0000-0002-5181-179X researchmap permalink read0090387 read0090387 Scopus Author ID 35429790100 35429790100 著者名 Uchiyama, Susumu
キーワード等	filter fouling
	flux decay
	initial flux
	microfiltration
	prediction model
	protein aggregates
内容	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.
抄録	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.
出版者	John Wiley and Sons Inc
収録物名	Biotechnology and Bioengineering
巻(号)	121(6)
ページ	1889-1901
刊行年月	2024-06-01
言語	英語
ハンドルURL	https://hdl.handle.net/11094/95748
PISSN	00063592
eISSN	10970290
関連情報 (isIdenticalTo)	DOI (出版社版) https://doi.org/10.1002/bit.28692
アクセス権	open access
権利情報	This article is licensed under a Creative Commons Attribution 4.0 International License.
出版タイプ	Version of Record
カテゴリ	学術雑誌論文 Journal Article

資源タイプ	学術雑誌論文
ローカル資源タイプ	学術雑誌論文
DCMI資源タイプ	text
DCTERMS.bibliographicCitation	Biotechnology and Bioengineering. 2024, 121(6), p. 1889-1901
DC.title	Prediction models for the flux decay profile and initial flux of microfiltration for therapeutic proteins
DC.creator	Inoue, Kota
	Masuda, Yumiko
	Torisu, Tetsuo
	Nonaka, Koichi
	Uchiyama, Susumu
DC.publisher	John Wiley and Sons Inc
DC.language' scheme='DCTERMS.RFC1766	英語
DC.type' scheme='DCTERMS.DCMIType	text
DCTERMS.issued' scheme='DCTERMS.W3CDTF	2024-06-01
DC.identifier	https://doi.org/10.1002/bit.28692
DC.subject	filter fouling
	flux decay
	initial flux
	microfiltration
	prediction model
	protein aggregates
DC.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.
DCTERMS.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.
DC.rights	This article is licensed under a Creative Commons Attribution 4.0 International License.
DC.format	95748
citation_title	Prediction models for the flux decay profile and initial flux of microfiltration for therapeutic proteins
citation_author	Inoue, Kota
	Masuda, Yumiko
	Torisu, Tetsuo
	Nonaka, Koichi
	Uchiyama, Susumu
citation_publisher	John Wiley and Sons Inc
citation_language	英語
citation_date	2024-06-01
citation_journal_title	Biotechnology and Bioengineering
citation_volume	121
citation_issue	6
citation_firstpage	1889
citation_lastpage	1901
citation_doi	https://doi.org/10.1002/bit.28692
citation_public_url	https://hdl.handle.net/11094/95748

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

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