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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
Endotoxin
Mycoplasma
Bioburden
RESOURCES BY TEST METHOD
Cell-Based Assay
Documentary Standards
<63> Mycoplasma Tests
<1125> Nucleic Acid-Based Techniques—General
