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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 BY TEST METHOD
Visual Inspection
Documentary Standards
<630> Visual Comparison
<631> Color and Achromicity
<790> Visible Particulates in Injections
<1790> Visual Inspection of Injections
Visible Particulates
Documentary Standards
<790> Visible Particulates in Injections
<1790> Visual Inspection of Injections
Reference Standards
1500502: Particle Count
Subvisible Particles
Documentary Standards
<429> Light Diffraction Measurement of Particle Size
<430> Particle Size Analysis by Dynamic Light Scattering
<787> Subvisible Particulate Matter in Therapeutic Protein Injections
<788> Particulate Matter in Injections
<1788> Methods for the Determination of Subvisible Particulate Matter
