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3 results on '"Golubev, Eugen"'

1. Two-Step Size-Exclusion Nanofiltration of Prothrombin Complex Concentrate Using Nanocellulose-Based Filter Paper

Author

Manukyan, Levon, Mantas, Athanasios, Razumikhin, Mikhail, Katalevsky, Andrey, Golubev, Eugen, and Mihranyan, Albert

Subjects
Mikrobiologi, lcsh:Biology (General), Cladophora cellulose, hemophilia b, hemophilia B, virus removal filtration, mille-feuille filter, protein aggregates, lcsh:QH301-705.5, Mille-feuille filter, Microbiology, Article, cladophora cellulose
Abstract

Coagulation Factor IX-rich protrhombin complex concentrate (FIX-PCC) is a therapeutic biologic product that consists of a mixture of several human plasma-derived proteins, useful for treating hemophilia B. Due to its complex composition, FIX-PCC is very challenging to bioprocess through virus removing nanofilters in order to ensure its biosafety. This article describes a two-step filtration process of FIX-PCC using a nanocellulose-based filter paper with tailored porosity. The filters were characterized with scanning electron microscopy (SEM), cryoporometry with differential scanning calorimetry, and nitrogen gas sorption. Furthermore, in order to probe the filter’s cut-off size rejection threshold, removal of small- and large-size model viruses, i.e., ΦX174 (28 nm) and PR772 (70 nm), was evaluated. The feed, pre-filtrate, and permeate solutions were characterized with mass-spectrometric proteomic analysis, dynamic light scattering (DLS), sodium dodecyl sulfate-polyacrylamide gel electrophoresis (SDS-PAGE), and analytical size-exclusion high-performance liquid chromatography (SEHPLC). By sequential filtration through 11 μm pre-filter and 33 μm virus removal filter paper, it was possible to achieve high product throughput and high virus removal capacity. The presented approach could potentially be applied for bioprocessing other protein-based drugs.

Published
2020

3. Virus Removal Nanofiltration of Factor IX-rich Prothrombin Complex Concentrate Using Nanocellulose-based Filter Paper

Author

Manukyan, Levon, Mantas, Athanasios, Razumikhin, Mikhail, Katalevsky, Andrey, Golubev, Eugen, Mihranyan, Albert, Manukyan, Levon, Mantas, Athanasios, Razumikhin, Mikhail, Katalevsky, Andrey, Golubev, Eugen, and Mihranyan, Albert

Abstract

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.

Published
2019

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