Evidence map›Paper›PMID 31720304›Full record

ArticleMolecular therapy. Methods & clinical development2019

Developing an Anion Exchange Chromatography Assay for Determining Empty and Full Capsid Contents in AAV6.2.

Chunlei Wang, Sri Hari Raju Mulagapati, Zhongying Chen, Jing Du, Xiaohui Zhao, Guoling Xi, Liyan Chen, Thomas Linke, Cuihua Gao, Albert E Schmelzer and 1 more

Open access · goldAbstract read
In one paragraph

Article in Molecular therapy. Methods & clinical development, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 46 papers.

0numbers the graph read from it
0cells of the map it votes in
46citing papers in PubMed
6.3field-weighted citation impact, top 3% 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

46 citing papers in PubMed, 105 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

11 authors at 1 institution in 1 country.

Chunlei WangAnalytical Sciences, Biopharmaceutical Development, BioPharmaceuticals R&D, AstraZeneca, One MedImmune Way, Gaithersburg, MD 20878, USA.
Sri Hari Raju MulagapatiAnalytical Sciences, Biopharmaceutical Development, BioPharmaceuticals R&D, AstraZeneca, One MedImmune Way, Gaithersburg, MD 20878, USA.
Zhongying ChenAnalytical Sciences, Biopharmaceutical Development, BioPharmaceuticals R&D, AstraZeneca, One MedImmune Way, Gaithersburg, MD 20878, USA.
Jing DuAnalytical Sciences, Biopharmaceutical Development, BioPharmaceuticals R&D, AstraZeneca, One MedImmune Way, Gaithersburg, MD 20878, USA.
Xiaohui ZhaoAnalytical Sciences, Biopharmaceutical Development, BioPharmaceuticals R&D, AstraZeneca, One MedImmune Way, Gaithersburg, MD 20878, USA.
Guoling XiPurification Process Sciences, Biopharmaceutical Development, BioPharmaceuticals R&D, AstraZeneca, One MedImmune Way, Gaithersburg, MD 20878, USA.
Liyan ChenPurification Process Sciences, Biopharmaceutical Development, BioPharmaceuticals R&D, AstraZeneca, One MedImmune Way, Gaithersburg, MD 20878, USA.
Thomas LinkePurification Process Sciences, Biopharmaceutical Development, BioPharmaceuticals R&D, AstraZeneca, One MedImmune Way, Gaithersburg, MD 20878, USA.
Cuihua GaoAntibody Discovery and Protein Engineering, R&D, AstraZeneca, One MedImmune Way, Gaithersburg, MD 20878, USA.
Albert E SchmelzerCell Culture and Fermentation Sciences, Biopharmaceutical Development, BioPharmaceuticals R&D, AstraZeneca, One MedImmune Way, Gaithersburg, MD 20878, USA.
Dengfeng LiuAnalytical Sciences, Biopharmaceutical Development, BioPharmaceuticals R&D, AstraZeneca, One MedImmune Way, Gaithersburg, MD 20878, USA.
AstraZeneca (United States) · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Adeno-associated virus (AAV) vectors are clinically proven gene delivery vehicles that are attracting an increasing amount of attention. Non-genome-containing empty AAV capsids are by-products during AAV production that have been reported to potentially impact AAV product safety and efficacy. Therefore, the presence and amount of empty AAV capsids need to be characterized during process development. Multiple methods have been reported to characterize empty AAV capsid levels, including transmission electron microscopy (TEM), analytical ultracentrifugation (AUC), charge detection mass spectrometry (CDMS), UV spectrophotometry, and measuring capsid and genome copies by ELISA and qPCR. However, these methods may lack adequate accuracy and precision or be challenging to transfer to a quality control (QC) lab due to the difficulty of implementation. In this study, we used AAV serotype 6.2 (AAV6.2) as an example to show the development of a QC-friendly anion exchange chromatography (AEX) assay for the determination of empty and full capsid percentages. The reported assay requires several microliters of material with a minimum titer of 5 × 10

Indexed as

AAVAAV6.2Anion exchange chromatography (AEC)AUCChromatographyEmpty capsidsHigh-throughput

Identifiers

PMID31720304
PMCPMC6838793
OpenAlexW2975867742

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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.