ArticleBiotechnology progress
Performance of large virus removal filters during AAV processing: Influence of flux and process disruptions.
Article in Biotechnology progress. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.
What it found
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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.
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.
Who cites it
1 citing paper in PubMed.
- Performance of large virus removal filters during AAV processing: Influence of flux and process disruptions.Biotechnology progressArticle
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
6 authors.
Funding
Abstract
As adeno-associated viral vectors (AAV) continue to advance through the clinical pipeline, effective downstream purification strategies must be developed to ensure bulk drug purity and safety. AAV are produced within mammalian cells, bringing forth risks associated with viral contamination. Although existing downstream operations provide some degree of viral inactivation and removal, regulatory agencies have recommended the incorporation of a dedicated virus removal filtration step to ensure robust viral clearance. Recently published studies have demonstrated that membrane filters with nominal pore sizes between 35 and 50 nm can provide effective AAV transmission while removing larger viruses, although these results were obtained over a limited range of conditions. This study represents the first investigation into the effects of filtrate flux and process disruptions on virus reduction filtration for AAV. Experiments were performed using purified AAV capsids and carboxylate-modified polymeric nanoparticles with a nominal diameter of 20 nm. Initial results confirmed that both systems exhibited nearly identical transient transmission profiles during virus filtration. Virus filtration performed at various filtrate fluxes (between 20 and 185 L/m
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