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Gene Therapy Analytical Guide
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AAV
Raw & Starting Materials
Process & Product Characterization
Release & Stability
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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
<1049> Quality of Biotechnological Products: Stability Testing of Biotechnological/Biological Products
<1149> Guidelines for Assessing and Controlling the Physical Stability of Chemical and Biological Pharmaceutical Raw Materials, Intermediates, and Dosage Forms
<1191> Stability Considerations in Dispensing Practice
