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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
100% Visual Inspection
Appearance
Total Protein Content
pH
Osmolality
Filling and Extractable Volume
CCIT
RESOURCES
Standards
Documentary Standards
<1> Injections and Implanted Drug Products (Parenterals)—Product Quality Tests
<697> Container Content for Injections
<698> Deliverable Volume
<1151> Pharmaceutical Dosage Forms
