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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
Vector Genome Identity
Capsid Identity
RESOURCES BY TEST METHOD
NGS
Documentary Standards
<1125> Nucleic Acid-Based Techniques—General
<1126> Nucleic Acid-Based Techniques—Extraction, Detection, and Sequencing
PCR
Documentary Standards
<1127> Nucleic Acid-Based Techniques—Amplification
CGE
Documentary Standards
<1053> Capillary Electrophoresis
