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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
Capsid Content (Empty/Full)
Capsid Purity
Aggregation
Genome Integrity
PTM Analysis
Capsid Integrity/Stoichiometry
RESOURCES BY TEST METHOD
CE-SDS
Documentary Standards
<1053> Capillary Electrophoresis
SDS-PAGE
Documentary Standards
<1056> Biotechnology-Derived Articles—Polyacrylamide Gel Electrophoresis
ELISA
Documentary Standards
<1103> Immunological Test Methods—Enzyme-Linked Immunosorbent Assay (Elisa)
