ISO/DIS 16921-2

This Draft International Standard is in the enquiry phase with ISO members.

ISO/DIS 16921-2

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Abstract

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.

General information

Status
: Under development

You can help develop this draft international standard by contacting your national member

Stage
: DIS ballot initiated: 12 weeks [40.20]
Edition
: 1

Number of pages
: 31
Technical Committee :
ISO/TC 276/SC 1

ICS :
07.080
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