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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
Vector Genome Titer
Capsid Titer
RESOURCES BY TEST METHOD
ELISA
Documentary Standards
<1103> Immunological Test Methods—Enzyme-Linked Immunosorbent Assay (Elisa)
AEX
Documentary Standards
<621> Chromatography
<1047> Gene Therapy Products
<1503> Quality Attributes of Synthetic Peptide Drug Substances
SEC-MALS
Documentary Standards
<1430> Analytical Methodologies Based on Scattering Phenomena—General
<1430.1> Analytical Methodologies Based on Scattering Phenomena — Static Light Scattering
<1503> Quality Attributes of Synthetic Peptide Drug Substances
UV/OD (A260/280)
Documentary Standards
<857> Ultraviolet-Visible Spectroscopy
<1857> Ultraviolet-Visible Spectroscopy—Theory and Practice
