The links that follow were assembled by BioTechLogic to provide insight regarding therapeutic applications, manufacturing, compliance & regulatory management of Adeno-Associated Virus (AAV) in gene therapies.
- Engineering Adenoviruses for Gene Therapy
- Adeno Associated Virus (AAV) – An Introduction
- Making Adeno Associated Virus (AAV)
- Clinical Use of Adenoviral Vectors
Manufacturing & Production – Adeno-Associated Virus (AAV)
- Production and Titering of Recombinant Adeno-associated Viral Vectors (video)
- Production and Titering of Recombinant Adeno-Associated Viral Vectors (article)
- Large-Scale Recombinant Adeno-Associated Virus Production
- Co-packaging of Multiple Adeno-Associated Viral Vectors in a Single Production Step
- Cross-Packaging of a Single Adeno-Associated Virus (AAV) Type 2 Vector Genome into Multiple AAV Serotypes Enables Transduction with Broad Specificity
- Sample Protocol: A Protocol for AAV Vector Production and Purification
- Transient Transfection Methods for Clinical Adeno-Associated Viral Vector Production
- Manufacturing of Recombinant Adeno-Associated Viral Vectors: New Technologies Are Welcome
Compliance & Regulatory – Adeno-Associated Virus (AAV)
- Manufacturing of Gene Therapy Products – U.S. Pharmacopeia
- Guidance for Industry: Gene Therapy Clinical Trials – Observing Subjects for Delayed Adverse Events
- Guidance for FDA Reviewers and Sponsors: Content and Review of Chemistry, Manufacturing, and Control (CMC) Information for Human Gene Therapy Investigational New Drug Applications (INDs)
- AGTC Announces U.S. FDA Orphan Drug Designation for Gene Therapy to Treat Achromatopsia
- FDA Grants Breakthrough Status to Gene Therapy for First Time
- Rare Disease Advocacy Groups Receiving FDA Orphan Designations
Content provided by BioTechLogic.com – see also their most recent article: Process Validation and Regulatory Review in the Age of Fast Track, Breakthrough Therapy and Accelerated Approval Drugs.
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