Evidence map›Paper›PMID 36361506›Full record

ArticleInternational journal of molecular sciences2022

Biophysical Characterization of Adeno-Associated Virus Vectors Using Ion-Exchange Chromatography Coupled to Light Scattering Detectors.

Christina Wagner, Bernd Innthaler, Martin Lemmerer, Robert Pletzenauer, Ruth Birner-Gruenberger

Open access · goldAbstract read
In one paragraph

Article in International journal of molecular sciences, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed
3.6field-weighted citation impact, top 7% of its field
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

9 citing papers in PubMed, 19 citations in OpenAlex.

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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

5 authors at 2 institutions in 1 country.

Christina WagnerAnalytical Development Europe, Takeda Vienna, 1220 Vienna, Austria.
Bernd InnthalerGene Therapy Process Development, Takeda Orth an der Donau, 2304 Orth an der Donau, Austria.
Martin LemmererAnalytical Development Europe, Takeda Vienna, 1220 Vienna, Austria.
Robert PletzenauerGene Therapy Process Development, Takeda Orth an der Donau, 2304 Orth an der Donau, Austria.
Ruth Birner-GruenbergerInstitute of Chemical Technologies and Analytics, Technische Universität Wien, 1060 Vienna, Austria.ORCID 0000-0003-3950-0312
Takeda (Austria) · ATTU Wien · AT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Ion-exchange chromatography coupled to light scattering detectors represents a fast and simple analytical method for the assessment of multiple critical quality attributes (CQA) in one single measurement. The determination of CQAs play a crucial role in Adeno-Associated Virus (AAV)-based gene therapies and their applications in humans. Today, several different analytical techniques, including size-exclusion chromatography (SEC), analytical ultracentrifugation (AUC), qPCR or ELISA, are commonly used to characterize the gene therapy product regarding capsid titer, packaging efficiency, vector genome integrity, aggregation content and other process-related impurities. However, no universal method for the simultaneous determination of multiple CQAs is currently available. Here, we present a novel robust ion-exchange chromatography method coupled to multi-angle light scattering detectors (IEC-MALS) for the comprehensive characterization of empty and filled AAVs concerning capsid titer, full-to-total ratio, absolute molar mass of the protein and nucleic acid, and the size and polydispersity without baseline-separation of both species prior to data analysis. We demonstrate that the developed IEC-MALS assay is applicable to different serotypes and can be used as an orthogonal method to other established analytical techniques.

Indexed as

Capsid ProteinsDependovirusChromatography, GelChromatography, High Pressure LiquidChromatography, Ion ExchangeGenetic VectorsHumansLightCapsid Proteinsadeno-associated virus vectorscritical quality attributesdynamic light scatteringion-exchange chromatographymulti-angle light scatteringprotein characterization

Identifiers

PMID36361506
PMCPMC9655919
OpenAlexW4307265297

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

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.