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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
Capsid Content (Empty/Full)
Capsid Purity
Aggregation
Genome Integrity
RESOURCES BY TEST METHOD
CGE
Documentary Standards
<1056> Biotechnology-Derived Articles—Polyacrylamide Gel Electrophoresis
dPCR/qPCR
Documentary Standards
<1125> Nucleic Acid-Based Techniques—General
<1127> Nucleic Acid-Based Techniques—Amplification
<1047> Gene Therapy Products
NGS
Documentary Standards
<1047> Gene Therapy Products
<1125> Nucleic Acid-Based Techniques—General
<1127> Nucleic Acid-Based Techniques—Amplification
