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Gene Therapy Analytical Guide
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AAV
Raw & Starting Materials
Process & Product Characterization
Release & Stability
Contact
Process & Product Characterization
ATTRIBUTE CATEGORIES
Identity
Safety
Titer
Potency and Biological Activity
Product Purity
Process Impurities
Compendial Tests
QUALITY ATTRIBUTES
Appearance
Total Protein Content
pH
Osmolality
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: Octoxynol 9
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
