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ISO/TS 20853:2026

Biotechnology — Bioprocessing — General requirements for bacteriophage preparation for therapeutic use

General information

Valid from 05.02.2026
Directives or regulations
None

Standard history

Status
Date
Type
Name
05.02.2026
Main
This document specifies the minimum requirements for bacteriophage preparation processing including assessment on the titre and quality control.
The document applies to data processing of bacteriophage isolation, culture, characterization and storage.
This document applies to the quality evaluation/assessment of bacteriophage used for therapy.

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Standard monitoring