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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
Vector Genome Titer
Capsid Titer
RESOURCES BY TEST METHOD
ELISA
Documentary Standards
<1102> Immunological Test Methods—General Considerations
<1103> Immunological Test Methods—Enzyme-Linked Immunosorbent Assay (Elisa)
Anion Exchange Chromatography
Documentary Standards
<621> Chromatography
<1047> Gene Therapy Products
SEC-MALS
Documentary Standards
<430> Particle Size Analysis by Dynamic Light Scattering
<1430> Analytical Methodologies Based on Scattering Phenomena—General
<1430.1> Analytical Methodologies Based on Scattering Phenomena — Static Light Scattering
<1430.3> Analytical Methodologies Based on Scattering Phenomena—Dynamic Light Scattering
UV
Documentary Standards
<857> Ultraviolet-Visible Spectroscopy
<1857> Ultraviolet-Visible Spectroscopy—Theory and Practice
