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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
Capsid Content (Empty/Full)
Capsid Purity
Aggregation
Genome Integrity
PTM Analysis
Capsid Integrity/Stoichiometry
RESOURCES BY TEST METHOD
LC-MS
Documentary Standards
<736> Mass Spectrometry
<1055> Biotechnology-Derived Articles—Peptide Mapping
<1060> Mass Spectrometry-Based Multi-Attribute Method for Therapeutic Proteins
<1736> Applications of Mass Spectrometry
<1084> Glycoprotein and Glycan Analysis—General Considerations
SEC-MALS
Documentary Standards
<736> Mass Spectrometry
<1055> Biotechnology-Derived Articles—Peptide Mapping
<1060> Mass Spectrometry-Based Multi-Attribute Method for Therapeutic Proteins
<1084> Glycoprotein and Glycan Analysis—General Considerations
<1736> Applications of Mass Spectrometry
