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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
Endotoxin
Mycoplasma
Bioburden
RESOURCES BY TEST METHOD
Microbiological Examination
Documentary Standards
<61> Microbiological Examination of Nonsterile Products: Microbial Enumeration Tests
<62> Microbiological Examination of Nonsterile Products: Tests for Specified Microorganisms
<1111> Microbiological Examination of Nonsterile Products: Acceptance Criteria for Pharmaceutical Preparations and Substances for Pharmaceutical Use
<1119> Bioburden Monitoring
<1119.1> Bioburden Test
<1125> Nucleic Acid-Based Techniques—General
<1127> Nucleic Acid-Based Techniques—Amplification
