ArticleMolecular therapy. Methods & clinical development2021
Comparison of analytical techniques to quantitate the capsid content of adeno-associated viral vectors.
Article in Molecular therapy. Methods & clinical development, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 70 papers.
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Who cites it
70 citing papers in PubMed, 116 citations in OpenAlex.
- Review
- It's what's on the inside that counts: Capsid content as a critical quality attribute for AAV characterization.Molecular therapy. Advances · 2026Article
- High resolution ES-DMA quantifies AAV capsid DNA content by electrical mobility to mass correlation.Gene therapy · 2026Article
- Removal of Empty AAV Capsids to Undetectable Levels Using Orthogonal Purification Steps.Biotechnology and bioengineering · 2026Article
- Salt-Mediated Electro-Deformation of AAV Capsids Revealed by Nanopipette-Based Single-Particle Analysis.Analytical chemistry · 2026Article
- Orthogonal characterization of rAAV reveals vector attributes that drive ITR repair, self-complementary genome formation, and transgene expression.Molecular therapy. Nucleic acids · 2026Article
- Classification and quantification of full vs. empty adeno-associated virus reference capsids via infrared attenuated total reflection spectroscopy.Analytical and bioanalytical chemistry · 2026Article
- Optimization and scale up strategies for reproducible AAV enrichment step on CIMmultusGene therapy · 2026Article
- Methodological validation of a cryo-TEM-based detection method for empty capsid ratio in recombinant adeno-associated virus.Biochemistry and biophysics reports · 2026Article
- Mechanisms of Adeno-Associated Virus Serotype 9 Vector Characterization and Quality Control through Solid-State Nanopores.ACS nano · 2026Article
- AAV Capsid Modification and Its Influence on Viral Protein Stoichiometry and Packaging Fitness: Current Understandings and Future Direction.Molecular biotechnology · 2026Review
- Article
- pH-dependent DNA degradation pathways for adeno-associated virus gene therapy.Molecular therapy. Methods & clinical development · 2025Article
- End-to-end characterization of AAV manufacturing process using charge detection mass spectrometry.Molecular therapy. Methods & clinical development · 2025Article
- Development and implementation of an LC-MS-based multi-attribute method for adeno-associated virus.Molecular therapy. Methods & clinical development · 2025Article
- Mass photometry as a robust method for characterizing adeno-associated virus critical quality attributes in gene therapy vector.Molecular therapy. Nucleic acids · 2025Article
- Insights into Adeno-Associated Virus Capsid Charge Heterogeneity.Analytical chemistry · 2025Article
- Characterizing the Content and Structure of AAV Capsids by Size Exclusion Chromatography and Orbitrap-Based Charge Detection-Mass Spectrometry.Journal of the American Society for Mass Spectrometry · 2025Article
- Facilitating the simulation of sedimentation velocity data: new features of SViMULATE.European biophysics journal : EBJ · 2025Article
- A two-pass anion-exchange chromatography strategy for enrichment of full capsids in manufacturing of adeno-associated viral vectors.Molecular therapy. Methods & clinical development · 2025Article
10 more citing papers are in PubMed but not listed here.
Corrections and comments
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Authors and funding
11 authors at 2 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Adeno-associated virus (AAV) vectors, which contain a DNA transgene packaged into a protein capsid, have shown tremendous therapeutic potential in recent years. An inherent characteristic of the manufacturing process is production of empty capsids that lack the transgene and are therefore unable to provide the intended therapeutic benefit. The effect of empty capsids on clinical outcomes is not well understood, but there are immunogenicity and efficacy concerns, and these empty capsids are considered a product-related impurity. Therefore, empty capsids should be controlled during the manufacturing process and monitored through analytical testing, but there are limited techniques available that are capable of quantifying capsid content and even fewer that are amenable to validation and implementation as registered release tests in a regulated environment. In addition, there is currently not a widely accepted gold standard technique for quantifying capsid content, and the understanding of how the results compare between different orthogonal technologies is limited. The current study utilizes a comprehensive assessment to evaluate diverse analytical techniques for their ability to quantitate capsid content.
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Registered trials
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.