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Gene Therapy Analytical Guide
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AAV
Raw & Starting Materials
Process & Product Characterization
Release & Stability
Contact
Process & Product Characterization
ATTRIBUTE CATEGORIES
Identity
Safety
Titer
Potency and Biological Activity
Product Purity
Process Impurities
Compendial Tests
QUALITY ATTRIBUTES
In Vitro Expression Analysis
Transduction Efficiency
Endpoint Dilution Assay
Functional Potency
RESOURCES
Standards
Documentary Standards
<1235> Vaccines for Human Use—General Considerations
<1237> Virology Test Methods
