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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
Sterility
Endotoxin
Mycoplasma
Adventitious Viruses
Bioburden
rcAAV
RESOURCES
Standards
Documentary Standards
<71>Sterility Tests
<72> Respiration-Based Microbiological Methods for the Detection of Contamination in Short-Life Products
<73> ATP Bioluminescence-Based Microbiological Methods for the Detection of Contamination in Short-Life Products
<74> Coming Soon
<1071> Rapid Microbial Tests for Release of Sterile Short-Life Products: A Risk-Based Approach
