Commentary: Multiplex dPCR and SV-AUC are Promising Assays to Robustly Monitor the Critical Quality Attribute of AAV Drug Product Integrity

Characterization of Viral Genome Encapsidated in Adeno-associated Recombinant Vectors Produced in Yeast Saccharomyces cerevisiae

(2021) Alvaro Galli et al.   MOLECULAR BIOTECHNOLOGY

Evolving AAV-delivered therapeutics towards ultimate cures

(2021) Xiangjun He et al.   JOURNAL OF MOLECULAR MEDICINE-JMM

Anti-AAV Antibodies in AAV Gene Therapy: Current Challenges and Possible Solutions

(2021) Thomas Weber   Frontiers in Immunology

Comparison of Analytical Techniques to Quantitate the Capsid Content of Adeno-Associated Viral Vectors

(2021) Amanda K. Werle et al.   Molecular Therapy-Methods & Clinical Development

Planet of the AAVs: The Spinal Cord Injury Episode

(2021) Katerina Stepankova et al.   Biomedicines

Comprehensive Size Distribution and Composition Analysis of Adeno-Associated Virus Vector by Multiwavelength Sedimentation Velocity Analytical Ultracentrifugation

(2021) Takahiro Maruno et al.   JOURNAL OF PHARMACEUTICAL SCIENCES

AAV Vector Immunogenicity in Humans: A Long Journey to Successful Gene Transfer

(2020) Helena Costa Verdera et al.   MOLECULAR THERAPY

AAV-Genome Population Sequencing of Vectors Packaging CRISPR Components Reveals Design-Influenced Heterogeneity

(2020) Ngoc Tam Tran et al.   Molecular Therapy-Methods & Clinical Development

2D droplet digital PCR as a tool for titration and integrity evaluation of recombinant adeno-associated viral vectors

(2019) Birei Furuta-Hanawa et al.   Human Gene Therapy Methods

Shifting Paradigms Revisited: Biotechnology and the Pharmaceutical Sciences

(2019) Daan J.A. Crommelin et al.   JOURNAL OF PHARMACEUTICAL SCIENCES

Flow Microscopy Imaging Is Sensitive to Characteristics of Subvisible Particles in Peginesatide Formulations Associated With Severe Adverse Reactions

(2018) Austin L. Daniels et al.   JOURNAL OF PHARMACEUTICAL SCIENCES

Syngeneic AAV Pseudo-particles Potentiate Gene Transduction of AAV Vectors

(2017) Qizhao Wang et al.   Molecular Therapy-Methods & Clinical Development

Resolving Adeno-Associated Viral Particle Diversity With Charge Detection Mass Spectrometry

(2016) Elizabeth E. Pierson et al.   ANALYTICAL CHEMISTRY

Peginesatide for the treatment of anemia due to chronic kidney disease – an unfulfilled promise

(2016) Terhi Hermanson et al.   Expert Opinion On Drug Safety

Subvisible Particle Content, Formulation, and Dose of an Erythropoietin Peptide Mimetic Product Are Associated With Severe Adverse Postmarketing Events

(2016) Joseph Kotarek et al.   JOURNAL OF PHARMACEUTICAL SCIENCES

An Opportunity for Industry–Academia Partnership: Training the Next Generation of Industrial Researchers in Characterizing Higher Order Protein Structure

(2016) David L. Bain et al.   JOURNAL OF PHARMACEUTICAL SCIENCES

Managing uncertainty: A perspective on risk pertaining to product quality attributes as they bear on immunogenicity of therapeutic proteins

(2012) Amy S. Rosenberg et al.   JOURNAL OF PHARMACEUTICAL SCIENCES

An Industry Perspective on the Monitoring of Subvisible Particles as a Quality Attribute for Protein Therapeutics

(2010) Satish K. Singh et al.   JOURNAL OF PHARMACEUTICAL SCIENCES