Dataset Information

Nanofiltration as a robust method contributing to viral safety of plasma-derived therapeutics: 20?years' experience of the plasma protein manufacturers.

ABSTRACT:

Background

Nanofiltration entails the filtering of protein solutions through membranes with pores of nanometric sizes that have the capability to effectively retain a wide range of viruses.

Study design and methods

Data were collected from 754 virus validation studies (individual data points) by Plasma Protein Therapeutics Association member companies and analyzed for the capacity of a range of nanofilters to remove viruses with different physicochemical properties and sizes. Different plasma product intermediates were spiked with viruses and filtered through nanofilters with different pore sizes using either tangential or dead-end mode under constant pressure or constant flow. Filtration was performed according to validated scaled-down laboratory conditions reflecting manufacturing processes. Effectiveness of viral removal was assessed using cell culture infectivity assays or polymerase chain reaction (PCR).

Results

The nanofiltration process demonstrated a high efficacy and robustness for virus removal. The main factors affecting nanofiltration efficacy are nanofilter pore size and virus size. The capacity of nanofilters to remove smaller, nonenveloped viruses was dependent on filter pore size and whether the nanofiltration process was integrated and designed with the intention to provide effective parvovirus retention. Volume filtered, operating pressure, and total protein concentration did not have a significant impact on the effectiveness of virus removal capacity within the investigated ranges.

Conclusions

The largest and most diverse nanofiltration data collection to date substantiates the effectiveness and robustness of nanofiltration in virus removal under manufacturing conditions of different plasma-derived proteins. Nanofiltration can enhance product safety by providing very high removal capacity of viruses including small non-enveloped viruses.

SUBMITTER: Roth NJ

PROVIDER: S-EPMC7754444 | biostudies-literature | 2020 Nov

REPOSITORIES: biostudies-literature

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Publications

Nanofiltration as a robust method contributing to viral safety of plasma-derived therapeutics: 20 years' experience of the plasma protein manufacturers.

Roth Nathan J NJ Dichtelmüller Herbert O HO Fabbrizzi Fabrizio F Flechsig Eckhard E Gröner Albrecht A Gustafson Mary M Jorquera Juan I JI Kreil Thomas R TR Misztela Dominika D Moretti Elisa E Moscardini Mila M Poelsler Gerhard G More John J Roberts Peter P Wieser Andreas A Gajardo Rodrigo R

Transfusion 20200819 11

<h4>Background</h4>Nanofiltration entails the filtering of protein solutions through membranes with pores of nanometric sizes that have the capability to effectively retain a wide range of viruses.<h4>Study design and methods</h4>Data were collected from 754 virus validation studies (individual data points) by Plasma Protein Therapeutics Association member companies and analyzed for the capacity of a range of nanofilters to remove viruses with different physicochemical properties and sizes. Diff ...[more]

PMID: 32815181

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