ISO/NP 16921-4

Biotechnology — Gene delivery systems — Part 4: General Considerations for Characterization of the Capsid Protein Particle Population in AAV Products

Апстракт

This document establishes general requirements and recommended practices for establishing a characterization framework for analysis of capsid proteins associated with viral vectors, virus‑like particles (VLPs), bacteriophages and related supramolecular biological assemblies. It covers the principal orthogonal analytical methodologies used to evaluate the attributes of identity, purity, compositional/structural integrity (including post‑translational modifications, PTMs) and consistency of capsid proteins across batches and throughout the product lifecycle.
This standard is intended to support developers and manufacturers of AAV-based medicinal products in ensuring product quality and to facilitate the meeting of regulatory requirements. It applies to research, development and quality control activities for products in biopharmaceutical, diagnostic and academic settings. However, ultimate responsibility for product quality and compliance remains with the developer, manufacturer or sponsor. It is not intended to provide step‑by‑step laboratory procedures.