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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
Plastic Components
Stability
Excipients
Leachables/Extractables
RESOURCES
Standards
Documentary Standards
<621> Chromatography
<797> Pharmaceutical Compounding—Sterile Preparations
<1059> Excipient Performance
<1074> Excipient Biological Safety Evaluation Guidelines
<1078> Good Manufacturing Practices for Bulk Pharmaceutical Excipients
<1195> Significant Change for Bulk Pharmaceutical Excipients
