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Virus Removal Nanofiltration of Factor IX-rich Prothrombin Complex Concentrate Using Nanocellulose-based Filter Paper
Uppsala University, Disciplinary Domain of Science and Technology, Technology, Department of Engineering Sciences, Nanotechnology and Functional Materials.ORCID iD: 0000-0003-3314-5284
Uppsala University, Disciplinary Domain of Science and Technology, Technology, Department of Engineering Sciences, Nanotechnology and Functional Materials.ORCID iD: 0000-0001-5547-7816
Nacimbio JC.
Biopharmgarant LLC.
Show others and affiliations
2019 (English)Conference paper, Poster (with or without abstract) (Refereed)
Abstract [en]

Replacement therapy using plasma-derived Factor IX products is a life-saving treatment for patients with hemophilia B. Ensuring viral safety of plasma-derived Factor IX products is a critical issue during their bioprocessing. Although nanofiltration is an attractive method for clearing viruses from plasma-derived Factor IX products, additional efforts need to be implemented to enhance product throughput. Various large molecular weight protein impurities and/or soluble aggregates, which are not retained on sterilizing grade 0.2 μm filters, may cause filter fouling and thereby interrupt the manufacturing. Here, for the first time, the nanofiltration of coagulation factor IX-rich prothrombin complex concentrate is shown using a nanocellulose-based virus removal filter paper, aka the mille-feuille filter paper. Furthermore, a new method of soluble aggregate removal is developed. As a result, high product recovery and high virus clearance capacity are demonstrated. The mille-feuille filter paper has a tailored pore size in the nm-range in the region most suitable for targeted removal of soluble protein aggregates and small-size viruses from biologics solutions. The filter paper is produced according to traditional paper making technology and consists of 100% cellulose nanofibers. The mille-feuille filter paper offers new possibilities in developing cost-efficient and robust bioprocesses for manufacturing plasma-derived hemophilia products.

Place, publisher, year, edition, pages
2019.
National Category
Nano Technology
Research subject
Engineering Science with specialization in Nanotechnology and Functional Materials
Identifiers
URN: urn:nbn:se:uu:diva-395270OAI: oai:DiVA.org:uu-395270DiVA, id: diva2:1361592
Conference
Plasma Product Biotechnology
Available from: 2019-10-16 Created: 2019-10-16 Last updated: 2019-10-25Bibliographically approved

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Mihranyan, Albert

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