Evidence map›Paper›PMID 28556575›Full record

ArticleBiotechnology progress2017

Characterizing the impact of pressure on virus filtration processes and establishing design spaces to ensure effective parvovirus removal.

Daniel Strauss, Joshua Goldstein, Tomoko Hongo-Hirasaki, Yoshiro Yokoyama, Naokatsu Hirotomi, Tomoyuki Miyabayashi, Dominick Vacante

Abstract read
In one paragraph

Article in Biotechnology progress, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 13 papers.

0numbers the graph read from it
0cells of the map it votes in
13citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

13 citing papers in PubMed.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

7 authors.

Daniel StraussAsahi Kasei Bioprocess America, Inc., Glenview, IL, 60026.ORCID http://orcid.org/0000-0002-4907-1403
Joshua GoldsteinJanssen Research and Development, Malvern, PA, 19355.
Tomoko Hongo-HirasakiAsahi Kasei Medical Co., Ltd., Chiyoda-ku, Tokyo, 101-8101, Japan.
Yoshiro YokoyamaAsahi Kasei Medical Co., Ltd., Chiyoda-ku, Tokyo, 101-8101, Japan.
Naokatsu HirotomiAsahi Kasei Bioprocess America, Inc., Glenview, IL, 60026.
Tomoyuki MiyabayashiAsahi Kasei Medical Co., Ltd., Chiyoda-ku, Tokyo, 101-8101, Japan.
Dominick VacanteJanssen Research and Development, Malvern, PA, 19355.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Virus filtration provides robust removal of potential viral contaminants and is a critical step during the manufacture of biotherapeutic products. However, recent studies have shown that small virus removal can be impacted by low operating pressure and depressurization. To better understand the impact of these conditions and to define robust virus filtration design spaces, we conducted multivariate analyses to evaluate parvovirus removal over wide ranges of operating pressure, solution pH, and conductivity for three mAb products on Planova™ BioEX and 20N filters. Pressure ranges from 0.69 to 3.43 bar (10.0-49.7 psi) for Planova BioEX filters and from 0.50 to 1.10 bar (7.3 to 16.0 psi) for Planova 20N filters were identified as ranges over which effective removal of parvovirus is achieved for different products over wide ranges of pH and conductivity. Viral clearance at operating pressure below the robust pressure range suggests that effective parvovirus removal can be achieved at low pressure but that Minute virus of mice (MVM) logarithmic reduction value (LRV) results may be impacted by product and solution conditions. These results establish robust design spaces for Planova BioEX and 20N filters where high parvovirus clearance can be expected for most antibody products and provide further understanding of viral clearance mechanisms. © 2017 American Institute of Chemical Engineers Biotechnol. Prog., 33:1294-1302, 2017.

Indexed as

AnimalsCell LineFiltrationHydrogen-Ion ConcentrationMiceParvovirusPressureRecombinant ProteinsResearch DesignRecombinant Proteinsdesign spacelow pressureparvovirusviral clearancevirus retentive filtration

Identifiers

PMID28556575
PMCPMC6585929

What OpenQuestion holds

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LicenceCC BY-NC
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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.