ISO/DTS 20853

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

General information

Current stage: 50.00 Effective date: 22 gush 2025

Originator: ISO

Owner: ISO/TC 276

Type: Technical Specification

Scope

This document describes the minimum requirements for bacteriophage preparation processing
including the assessment of the titer and quality control.
This document applies to data processing of bacteriophage isolation, culture, purification and storage.
This document applies to the quality evaluation/assessment of bacteriophage used for therapy.

Life cycle

NOW

IN_DEVELOPMENT
ISO/DTS 20853
50.00 Final text received or FDIS registered for formal approval
22 gush 2025