ISO/DIS 16921-2

En desarrollo

Este borrador de Norma Internacional se encuentra en la fase de consultas con los miembros de ISO.

Resumen

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.