Skip to main content
Gene Therapy Analytical Guide
Menu
Main navigation
Close button
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
100% Visual Inspection
Appearance
Total Protein Content
pH
Osmolality
Filling and Extractable Volume
CCIT
RESOURCES
Standards
Documentary Standards
<1207> Package Integrity Evaluation—Sterile Products
<1207.1> Package Integrity Testing in the Product Life Cycle—Test Method Selection and Validation
<1207.2> Package Integrity Leak Test Technologies
<1207.3> Package Seal Quality Test Technologies
