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Gene Therapy Analytical Guide
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AAV
Raw & Starting Materials
Process & Product Characterization
Release & Stability
Contact
Release & Stability
ATTRIBUTE CATEGORIES
Identity
Safety
Titer
Potency and Biological Activity
Product Purity
Process Impurities
Compendial Tests
Other
QUALITY ATTRIBUTES
Sterility
Endotoxin
Mycoplasma
Adventitious Viruses
Bioburden
rcAAV
RESOURCES
Standards
Documentary Standards
<1050> Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin
<1050.1> Design, Evaluation, and Characterization of Viral Clearance Procedures
<1229.18> Viral Clearance Methods
<1237> Virology Test Methods
