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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
LC-MS
Documentary Standards
<621> Chromatography
<736> Mass Spectrometry
Reference Standards
1477502: Octoxynol 9
1547925: Polysorbate 20
1547969: Polysorbate 80
LC-CAD
Documentary Standards
<621> Chromatography
Reference Standards
1477502: Octoxynol 9
1547925: Polysorbate 20
1547969: Polysorbate 80
