uu.seUppsala University Publications
Change search
CiteExportLink to record
Permanent link

Direct link
Cite
Citation style
  • apa
  • ieee
  • modern-language-association
  • vancouver
  • Other style
More styles
Language
  • de-DE
  • en-GB
  • en-US
  • fi-FI
  • nn-NO
  • nn-NB
  • sv-SE
  • Other locale
More languages
Output format
  • html
  • text
  • asciidoc
  • rtf
Nanocellulose-Based Nanoporous Filter Paper for Virus Removal Filtration of Human Intravenous Immunoglobulin
Uppsala University, Disciplinary Domain of Science and Technology, Technology, Department of Materials Science and Engineering, Nanotechnology and Functional Materials.ORCID iD: 0000-0002-2572-9960
Uppsala University, Disciplinary Domain of Science and Technology, Technology, Department of Materials Science and Engineering, Nanotechnology and Functional Materials.ORCID iD: 0000-0003-3314-5284
Uppsala University, Disciplinary Domain of Science and Technology, Technology, Department of Materials Science and Engineering, Nanotechnology and Functional Materials.
Uppsala University, Disciplinary Domain of Science and Technology, Technology, Department of Materials Science and Engineering, Nanotechnology and Functional Materials.ORCID iD: 0000-0002-8105-2317
2019 (English)In: ACS APPLIED NANO MATERIALS, ISSN 2574-0970, Vol. 2, no 10, p. 6352-6359Article in journal (Refereed) Published
Abstract [en]

Human intravenous immunoglobulin (IVIG) is a highly valuable plasma-derived biotherapeutic with several important clinical indications in primary and acquired immunodeficiencies as well as autoimmune diseases, especially neuropathies. Ensuring the viral safety of plasma-derived products, such as human WIG, is mandatory. Viral filtration is commonly used to affect viral removal in the manufacture of plasma products. Viral filtration of large volumes of a IVIG feed solution can take significant time, the required filter area can be large, and the resultant total cost of filtration is considerable. Therefore, there is a need for a high-capacity filter, which can process large volumes of plasma-derived biotherapeutic products within a short time at reduced cost. Here, we describe for the first time the performance of a nanocellulose-based virus removal filter paper in the processing of human IVIG, which has the potential to address the above- stated issues. The filter exhibited 5-6 log virus clearance of Phi X174 (28 nm; pI 6.6) or MS2 (27 nm; pI 3.9) phages during the filtration of spiked IVIG solutions (11 mg/mL, pH 4.9). To simulate real-life production conditions, filtration at 288 L/m(2), corresponding to 3 kg of protein/m(2), at 3 bar was undertaken. No substantial filter fouling was evident, with the flux remaining stable throughout filtration at 20-30 L/m(2).h. The predicted volumetric capacity V-max was >= 1700 L/m(2), which corresponds to the processing of >= 19 kg/m(2) of immunoglobulins. A number of characterization tests encompassing size-exclusion high-pressure liquid chromatography, dynamic light scattering, and polyacrylamide gel electrophoresis confirmed immunoglobulin integrity before and after filtration. This study has shown that a mille-feuille filter paper manufacturing process offers the possibility of producing cost-efficient viral removal filters with the required performance capabilities suitable for the processing of plasma-derived immunoglobulins and recombinant monoclonal antibodies.

Place, publisher, year, edition, pages
AMER CHEMICAL SOC , 2019. Vol. 2, no 10, p. 6352-6359
Keywords [en]
plasma, immunoglobulin, size-exclusion filtration, mille-feuille filter paper, Cladophora cellulose
National Category
Medicinal Chemistry
Identifiers
URN: urn:nbn:se:uu:diva-406180DOI: 10.1021/acsanm.9b01351ISI: 000507667200031OAI: oai:DiVA.org:uu-406180DiVA, id: diva2:1412677
Funder
Knut and Alice Wallenberg Foundation, 2018.01141Swedish Research Council, 2016-05715EU, Horizon 2020Available from: 2020-03-06 Created: 2020-03-06 Last updated: 2020-03-06Bibliographically approved

Open Access in DiVA

No full text in DiVA

Other links

Publisher's full text

Authority records BETA

Wu, LuluManukyan, LevonMantas, AthanasiosMihranyan, Albert

Search in DiVA

By author/editor
Wu, LuluManukyan, LevonMantas, AthanasiosMihranyan, Albert
By organisation
Nanotechnology and Functional Materials
Medicinal Chemistry

Search outside of DiVA

GoogleGoogle Scholar

doi
urn-nbn

Altmetric score

doi
urn-nbn
Total: 13 hits
CiteExportLink to record
Permanent link

Direct link
Cite
Citation style
  • apa
  • ieee
  • modern-language-association
  • vancouver
  • Other style
More styles
Language
  • de-DE
  • en-GB
  • en-US
  • fi-FI
  • nn-NO
  • nn-NB
  • sv-SE
  • Other locale
More languages
Output format
  • html
  • text
  • asciidoc
  • rtf