ISO/TS 20853:2026Published

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

Biotechnologie — Bioprocédés — Exigences générales pour la préparation de bactériophages à usage thérapeutique

Abstract / scope

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.