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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
ELISA
Documentary Standards
<1102> Immunological Test Methods—General Considerations
<1103> Immunological Test Methods—Enzyme-Linked Immunosorbent Assay (Elisa)
<1132> Residual Host Cell Protein Measurement in Biopharmaceuticals
LC-MS
Documentary Standards
<736> Mass Spectrometry
<1132> Residual Host Cell Protein Measurement in Biopharmaceuticals
