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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
In Vitro Expression Analysis
Transduction Efficiency
Endpoint Dilution
Functional Potency
RESOURCES
Standards
Documentary Standards
<111> Design and Analysis of Biological Assays
<1027> Flow Cytometry
<1030> Biological Assay Chapters—Overview and Glossary
<1032> Design and Development of Biological Assays
<1033> Biological Assay Validation
<1034> Analysis of Biological Assays
<1103> Immunological Test Methods—Enzyme-Linked Immunosorbent Assay (Elisa)
<1125> Nucleic Acid-Based Techniques—General
<1127> Nucleic Acid-Based Techniques—Amplification
