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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
Capsid Content (Empty/Full)
Capsid Purity
Aggregation
Genome Integrity
PTM Analysis
Capsid Integrity/Stoichiometry
RESOURCES BY TEST METHOD
DLS
Documentary Standards
<430> Particle Size Analysis by Dynamic Light Scattering
TEM
Documentary Standards
<1047> Gene Therapy Products
SEC
Documentary Standards
<621> Chromatography