Evidence map›Paper›PMID 33923984›Full record

ArticlePharmaceutics2021

Characterization of Recombinant Adeno-Associated Viruses (rAAVs) for Gene Therapy Using Orthogonal Techniques.

Liam Cole, Diogo Fernandes, Maryam T Hussain, Michael Kaszuba, John Stenson, Natalia Markova

Abstract read
In one paragraph

Article in Pharmaceutics, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 29 papers.

0numbers the graph read from it
0cells of the map it votes in
29citing 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

29 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

6 authors.

Liam ColeMalvern Panalytical Ltd., Enigma Business Park, Grovewood Road, Malvern, Worcestershire WR14 1XZ, UK.
Diogo FernandesMalvern Panalytical Ltd., Enigma Business Park, Grovewood Road, Malvern, Worcestershire WR14 1XZ, UK.
Maryam T HussainMalvern Panalytical Ltd., Enigma Business Park, Grovewood Road, Malvern, Worcestershire WR14 1XZ, UK.
Michael KaszubaMalvern Panalytical Ltd., Enigma Business Park, Grovewood Road, Malvern, Worcestershire WR14 1XZ, UK.
John StensonMalvern Panalytical Ltd., Enigma Business Park, Grovewood Road, Malvern, Worcestershire WR14 1XZ, UK.
Natalia MarkovaMalvern Panalytical Ltd., Enigma Business Park, Grovewood Road, Malvern, Worcestershire WR14 1XZ, UK.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Viruses are increasingly used as vectors for delivery of genetic material for gene therapy and vaccine applications. Recombinant adeno-associated viruses (rAAVs) are a class of viral vector that is being investigated intensively in the development of gene therapies. To develop efficient rAAV therapies produced through controlled and economical manufacturing processes, multiple challenges need to be addressed starting from viral capsid design through identification of optimal process and formulation conditions to comprehensive quality control. Addressing these challenges requires fit-for-purpose analytics for extensive characterization of rAAV samples including measurements of capsid or particle titer, percentage of full rAAV particles, particle size, aggregate formation, thermal stability, genome release, and capsid charge, all of which may impact critical quality attributes of the final product. Importantly, there is a need for rapid analytical solutions not relying on the use of dedicated reagents and costly reference standards. In this study, we evaluate the capabilities of dynamic light scattering, multiangle dynamic light scattering, and SEC-MALS for analyses of rAAV5 samples in a broad range of viral concentrations (titers) at different levels of genome loading, sample heterogeneity, and sample conditions. The study shows that DLS and MADLS

Indexed as

differential scanning calorimetry (DSC)dynamic light scattering (DLS)high-throughputmultiangle dynamic light scattering (MADLS®)orthogonal techniquesrecombinant adeno-associated viruses (rAAV)SEC–MALS

Identifiers

PMID33923984
PMCPMC8074050

What OpenQuestion holds

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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.