release-stability | Gene Therapy Analytical Guide

Release & Stability

ATTRIBUTE CATEGORIES

QUALITY ATTRIBUTES

Capsid Content (Empty/Full)

Genome Integrity

RESOURCES BY TEST METHOD

Cryo-EM

Documentary Standards

<1047> Gene Therapy Products

AUC

Documentary Standards

<1047> Gene Therapy Products

SEC-MALS

Documentary Standards

<430> Particle Size Analysis by Dynamic Light Scattering

<1047> Gene Therapy Products

<1430> Analytical Methodologies Based on Scattering Phenomena—General

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

<1430.3> Analytical Methodologies Based on Scattering Phenomena—Dynamic Light Scattering

<1503> Quality Attributes of Synthetic Peptide Drug Substances

Anion Exchange Chromatography

Documentary Standards

<621> Chromatography

<1047> Gene Therapy Products

cIEF/icIEF

Documentary Standards

<1047> Gene Therapy Products

<1053> Capillary Electrophoresis

<1054> Biotechnology-Derived Articles—Isoelectric Focusing

CDMS

Documentary Standards

<1047> Gene Therapy Products