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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
Residual Plasmid DNA
Residual Pluronic
Residual Detergents
Residual Endonuclease
Residual HCP
Residual HCDNA
Residual HCRNA
RESOURCES BY TEST METHOD
qPCR/dPCR
Documentary Standards
<1125> Nucleic Acid-Based Techniques—General
<1127> Nucleic Acid-Based Techniques—Amplification
<1130> Nucleic Acid-Based Techniques—Approaches for Detecting Trace Nucleic Acids (Residual DNA Testing)
Reference Standards
1592106: Quantitative HEK-293 Genomic DNA
1592170: Quantitative Sf9 Genomic DNA
