release-stability | Gene Therapy Analytical Guide

Release & Stability

ATTRIBUTE CATEGORIES

QUALITY ATTRIBUTES

Vector Genome Identity

Capsid Identity

RESOURCES BY TEST METHOD

CE-SDS

Documentary Standards

<1053> Capillary Electrophoresis

SDS-PAGE

Documentary Standards

<1056> Biotechnology-Derived Articles—Polyacrylamide Gel Electrophoresis

Western Blot

Documentary Standards

<1102> Immunological Test Methods—General Considerations

ELISA

Documentary Standards

<1102> Immunological Test Methods—General Considerations

<1103> Immunological Test Methods—Enzyme-Linked Immunosorbent Assay (Elisa)

Western Blot

Documentary Standards

<1056> Biotechnology-Derived Articles—Polyacrylamide Gel Electrophoresis

<1104> Immunological Test Methods—Immunoblot Analysis

RP-HPLC

Documentary Standards

<621> Chromatography

LC-MS

Documentary Standards

<736> Mass Spectrometry

<1060> Mass Spectrometry-Based Multi-Attribute Method for Therapeutic Proteins

Peptide Mapping

Documentary Standards

<1055> Biotechnology-Derived Articles—Peptide Mapping

<621> Chromatography

MAM

Documentary Standards

<736> Mass Spectrometry

<1055> Biotechnology-Derived Articles—Peptide Mapping

<1060> Mass Spectrometry-Based Multi-Attribute Method for Therapeutic Proteins