Evidence map›Paper›PMID 39846448›Full record

ArticleBiotechnology progress

A design space for the filtration of challenging monoclonal antibodies using Planova™ S20N, a new regenerated cellulose virus removal filter.

Asami Inoue, Satoshi Murakami, Akika Futamura, Naoto Watanabe, Yumiko Masuda

Abstract read
In one paragraph

Article in Biotechnology progress. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing 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

2 citing papers in PubMed.

  1. Article
  2. Article
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

5 authors.

Asami InoueTechnology Development Department, Bioprocess Division, Asahi Kasei Medical Co., Ltd, Nobeoka, Miyazaki, Japan.ORCID 0009-0007-6832-5513
Satoshi MurakamiBiologics Technology Research Laboratories, Biologics Division, Daiichi Sankyo Co., Ltd, Oura-gun, Gunma, Japan.
Akika FutamuraScientific Affairs Group, Bioprocess Division, Asahi Kasei Medical Co., Ltd, Tokyo, Japan.
Naoto WatanabeScientific Affairs Group, Bioprocess Division, Asahi Kasei Medical Co., Ltd, Tokyo, Japan.
Yumiko MasudaBiologics Technology Research Laboratories, Biologics Division, Daiichi Sankyo Co., Ltd, Oura-gun, Gunma, Japan.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Virus removal by filtration is a crucial step in ensuring the safety of therapeutic antibodies and other biopharmaceutical products by mitigating the risk of endogenous and adventitious viral contamination. However, there are monoclonal antibodies (mAb) that are difficult to filter effectively using virus removal filters (i.e., challenging mAbs), necessitating the creation of guidelines for designing suitable filtration conditions for these challenging molecules. This study presents a filtration design space for filtration conditions using a new regenerated cellulose membrane filter with a representative challenging mAb. The filter demonstrated that filtration throughput is adaptable across a wide range of conditions for low to medium mAb concentrations, indicating its suitability for introduction into platform processes for related biopharmaceutical products.

Indexed as

Antibodies, MonoclonalCelluloseFiltrationVirusesAnimalsCHO CellsCricetulusAntibodies, MonoclonalCellulosedesign of experiments (DoE)design spaceimmunoglobulinsnanofiltrationvirus retentive filtration

Identifiers

PMID39846448
PMCPMC12171344

What OpenQuestion holds

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LicenceCC BY-NC-ND
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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.