ISO/CD 16921-2

Biotechnology — Gene delivery systems — Part 2: Guide for methods for the qualification of viral vectors

Scope

This document provides minimum requirements for quantifying viral vectors in term of physical titer and functional titer. It provides key considerations for general methods for viral vector quantification as well as for method selection, measurement process, data analysis, and reporting.

This document is applicable to all types of viral vectors (e.g., adeno-associated, adenovirus, retrovirus, lentivirus, herpesvirus) for therapeutic use, including their research and development.

This document is not intended for viral vectors for non-health sectors.