ISO/PWI 16944

Biotechnology — Guidance and requirements for assays used in the detection of anti-adeno-associated viruses (AAV) antibodies when evaluating preexisting immunity to AAV

General information

Current stage: 00.00 Effective date: Mar 21, 2022

Originator: ISO

Owner: ISO/TC 276

Type: International Standard

Scope

This document provides guidance for anti-adeno-associated viruses (AAV) total binding antibody (TAb)assays and cell-based assays measuring neutralization transduction (NAb assays) used in thedetermination of pre-existing immunity and the emerging immune response after the administration ofAAV based genomic medicine.This document provides requirements for data analysis and reporting for the TAb and NAb assays and isapplicable to assays conducted in research, pre-clinical, and clinical settings. Aspects of this document areapplicable to the assessment and development of the effectiveness of immune modulation strategies.The cellular immune response and assays used to measure cellular immunity are outside of the scope ofthis standard.

Life cycle

NOW

IN_DEVELOPMENT
ISO/PWI 16944
00.00 Proposal for new project received
Mar 21, 2022

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