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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
Plastic Components
Stability
Excipients
Leachables/Extractables
RESOURCES
Standards
Documentary Standards
<1663> Assessment of Extractables Associated with Pharmaceutical Packaging/Delivery Systems
<1664> Assessment of Drug Product Leachables Associated with Pharmaceutical Packaging/Delivery Systems
