ISO/NP 26012

General Requirements and Considerations for AAV Capsid Content Characterization for Gene Therapy

Scope

This document defines terminology related to capsid content characterization for AAV in gene therapy manufacturing.
The document provides guidance on assessment of capsid content for AAV based vectors including setting of limits and data to be used in lot release decisions throughout development.
This document provides a fit-for-purpose decision making framework for determining appropriate methods for capsid content characterization.
This document provides fit-for-purpose decision making for use and qualification of reference standards and materials used in assays for capsid content characterization.