A straightforward approach for converting existing batch production to an integrated continuous manufacturing suite by adopting membrane‐based technology.
Saved in:
| Title: | A straightforward approach for converting existing batch production to an integrated continuous manufacturing suite by adopting membrane‐based technology. |
|---|---|
| Authors: | Fang, Mingyue1 (AUTHOR), Shi, Ce1 (AUTHOR), Zhou, Anmin1 (AUTHOR), Zhu, Huilin1 (AUTHOR) zhu_huilin@wuxibiologics.com, Zhou, Hang1,2 (AUTHOR) zhou_hang@wuxibiologics.com, Gu, Sherry1,2,3 (AUTHOR), Zhou, Weichang1,2,3 (AUTHOR) |
| Source: | Biotechnology Progress. Sep/Oct2026, Vol. 42 Issue 5, p1-13. 13p. |
| Subjects: | Continuous processing, Membrane separation, Process optimization, Ion-permeable membranes, Membrane proteins |
| Abstract: | The rapidly developing antibody market poses challenges to the production cost and efficiency, which can be addressed through continuous process. However, a hurdle of high capital investment remains a concern especially for the company with existing fed‐batch capacity. This study proposes a straightforward approach to convert existing batch production suites into continuous ones using membrane‐based technology. A conceptual validation was conducted at a 100 L pilot scale, and a head‐to‐head comparison was carried out. The results demonstrated that Protein A membrane chromatography could achieve a productivity 6.3 times higher than that of periodic counter‐current chromatography (PCC), without requiring the purchase of any dedicated equipment. Using Q membrane, compared with traditional column anion exchange chromatography, can achieve a 16‐fold increase in load capacity and a 25‐fold increase in productivity. Finally, VF‐UF/DF (Virus Filtration‐Ultrafiltration/diafiltration) linkage process was designed, resulting in a 20% reduction in process time. During the 23‐day upstream perfusion and 15‐day downstream processing, the cumulative titer reached 51.0 g/L, with an 83.1% yield in downstream processing. With downstream process time shortening from 4 to 1.5 days, the process capacity could be improved by 8 times using the existing batch production suites and the same facility area. PATs, including ultra‐performance liquid chromatography, Raman spectroscopy, FlowVPX, and an inline turbidity meter, were integrated to monitor process CQAs (Critical Quality Attributes): monomer purity, protein concentration, and turbidity, to enable efficient process control in the future. [ABSTRACT FROM AUTHOR] |
| Copyright of Biotechnology Progress is the property of Wiley-Blackwell and its content may not be copied or emailed to multiple sites without the copyright holder's express written permission. Additionally, content may not be used with any artificial intelligence tools or machine learning technologies. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.) | |
| Database: | Engineering Source |
| FullText | Text: Availability: 0 |
|---|---|
| Header | DbId: egs DbLabel: Engineering Source An: 197591156 AccessLevel: 6 PubType: Academic Journal PubTypeId: academicJournal PreciseRelevancyScore: 0 |
| IllustrationInfo | |
| Items | – Name: Title Label: Title Group: Ti Data: A straightforward approach for converting existing batch production to an integrated continuous manufacturing suite by adopting membrane‐based technology. – Name: Author Label: Authors Group: Au Data: <searchLink fieldCode="AR" term="%22Fang%2C+Mingyue%22">Fang, Mingyue</searchLink><relatesTo>1</relatesTo> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Shi%2C+Ce%22">Shi, Ce</searchLink><relatesTo>1</relatesTo> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Zhou%2C+Anmin%22">Zhou, Anmin</searchLink><relatesTo>1</relatesTo> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Zhu%2C+Huilin%22">Zhu, Huilin</searchLink><relatesTo>1</relatesTo> (AUTHOR)<i> zhu_huilin@wuxibiologics.com</i><br /><searchLink fieldCode="AR" term="%22Zhou%2C+Hang%22">Zhou, Hang</searchLink><relatesTo>1,2</relatesTo> (AUTHOR)<i> zhou_hang@wuxibiologics.com</i><br /><searchLink fieldCode="AR" term="%22Gu%2C+Sherry%22">Gu, Sherry</searchLink><relatesTo>1,2,3</relatesTo> (AUTHOR)<br /><searchLink fieldCode="AR" term="%22Zhou%2C+Weichang%22">Zhou, Weichang</searchLink><relatesTo>1,2,3</relatesTo> (AUTHOR) – Name: TitleSource Label: Source Group: Src Data: <searchLink fieldCode="JN" term="%22Biotechnology+Progress%22">Biotechnology Progress</searchLink>. Sep/Oct2026, Vol. 42 Issue 5, p1-13. 13p. – Name: Subject Label: Subjects Group: Su Data: <searchLink fieldCode="DE" term="%22Continuous+processing%22">Continuous processing</searchLink><br /><searchLink fieldCode="DE" term="%22Membrane+separation%22">Membrane separation</searchLink><br /><searchLink fieldCode="DE" term="%22Process+optimization%22">Process optimization</searchLink><br /><searchLink fieldCode="DE" term="%22Ion-permeable+membranes%22">Ion-permeable membranes</searchLink><br /><searchLink fieldCode="DE" term="%22Membrane+proteins%22">Membrane proteins</searchLink> – Name: Abstract Label: Abstract Group: Ab Data: The rapidly developing antibody market poses challenges to the production cost and efficiency, which can be addressed through continuous process. However, a hurdle of high capital investment remains a concern especially for the company with existing fed‐batch capacity. This study proposes a straightforward approach to convert existing batch production suites into continuous ones using membrane‐based technology. A conceptual validation was conducted at a 100 L pilot scale, and a head‐to‐head comparison was carried out. The results demonstrated that Protein A membrane chromatography could achieve a productivity 6.3 times higher than that of periodic counter‐current chromatography (PCC), without requiring the purchase of any dedicated equipment. Using Q membrane, compared with traditional column anion exchange chromatography, can achieve a 16‐fold increase in load capacity and a 25‐fold increase in productivity. Finally, VF‐UF/DF (Virus Filtration‐Ultrafiltration/diafiltration) linkage process was designed, resulting in a 20% reduction in process time. During the 23‐day upstream perfusion and 15‐day downstream processing, the cumulative titer reached 51.0 g/L, with an 83.1% yield in downstream processing. With downstream process time shortening from 4 to 1.5 days, the process capacity could be improved by 8 times using the existing batch production suites and the same facility area. PATs, including ultra‐performance liquid chromatography, Raman spectroscopy, FlowVPX, and an inline turbidity meter, were integrated to monitor process CQAs (Critical Quality Attributes): monomer purity, protein concentration, and turbidity, to enable efficient process control in the future. [ABSTRACT FROM AUTHOR] – Name: AbstractSuppliedCopyright Label: Group: Ab Data: <i>Copyright of Biotechnology Progress is the property of Wiley-Blackwell and its content may not be copied or emailed to multiple sites without the copyright holder's express written permission. Additionally, content may not be used with any artificial intelligence tools or machine learning technologies. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract.</i> (Copyright applies to all Abstracts.) |
| PLink | https://search.ebscohost.com/login.aspx?direct=true&site=eds-live&db=egs&AN=197591156 |
| RecordInfo | BibRecord: BibEntity: Identifiers: – Type: doi Value: 10.1002/btpr.88523 Languages: – Code: eng Text: English PhysicalDescription: Pagination: PageCount: 13 StartPage: 1 Subjects: – SubjectFull: Continuous processing Type: general – SubjectFull: Membrane separation Type: general – SubjectFull: Process optimization Type: general – SubjectFull: Ion-permeable membranes Type: general – SubjectFull: Membrane proteins Type: general Titles: – TitleFull: A straightforward approach for converting existing batch production to an integrated continuous manufacturing suite by adopting membrane‐based technology. Type: main BibRelationships: HasContributorRelationships: – PersonEntity: Name: NameFull: Fang, Mingyue – PersonEntity: Name: NameFull: Shi, Ce – PersonEntity: Name: NameFull: Zhou, Anmin – PersonEntity: Name: NameFull: Zhu, Huilin – PersonEntity: Name: NameFull: Zhou, Hang – PersonEntity: Name: NameFull: Gu, Sherry – PersonEntity: Name: NameFull: Zhou, Weichang IsPartOfRelationships: – BibEntity: Dates: – D: 01 M: 09 Text: Sep/Oct2026 Type: published Y: 2026 Identifiers: – Type: issn-print Value: 87567938 Numbering: – Type: volume Value: 42 – Type: issue Value: 5 Titles: – TitleFull: Biotechnology Progress Type: main |
| ResultId | 1 |
