process-product-characterization | Gene Therapy Analytical Guide

Process & Product Characterization

ATTRIBUTE CATEGORIES

QUALITY ATTRIBUTES

Capsid Content (Empty/Full)

Genome Integrity

Capsid Integrity/Stoichiometry

RESOURCES BY TEST METHOD

Cryo-EM

Documentary Standards

<1047> Gene Therapy Products

Reference Standards

1000301: AAV8 (Empty Capsids)

1000302: AAV8 (Full Capsids)

AUC

Documentary Standards

<1047> Gene Therapy Products

Reference Standards

1000301: AAV8 (Empty Capsids)

1000302: AAV8 (Full Capsids)

SEC-MALS

Documentary Standards

<1047> Gene Therapy Products

<1430> Analytical Methodologies Based on Scattering Phenomena—General

<1430.1> Analytical Methodologies Based on Scattering Phenomena — Static Light Scattering

<1503> Quality Attributes of Synthetic Peptide Drug Substances

Reference Standards

1000301: AAV8 (Empty Capsids)

1000302: AAV8 (Full Capsids)

Anion Exchange Chromatography (AEC)

Documentary Standards

<621> Chromatography

<1047> Gene Therapy Products

Reference Standards

1000301: AAV8 (Empty Capsids)

1000302: AAV8 (Full Capsids)

cIEF/icIEF

Documentary Standards

<1047> Gene Therapy Products

<1053> Capillary Electrophoresis

<1054> Biotechnology-Derived Articles—Isoelectric Focusing

Reference Standards

1000301: AAV8 (Empty Capsids)

1000302: AAV8 (Full Capsids)

CDMS

Documentary Standards

<1047> Gene Therapy Products

Reference Standards

1000301: AAV8 (Empty Capsids)

1000302: AAV8 (Full Capsids)

Mass Photometry

Reference Standards

1000301: AAV8 (Empty Capsids)

1000302: AAV8 (Full Capsids)