Comment by: 2 September
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.
Purpose
With the continuous and expanded utilization of phage therapy during clinical trials of life-threatening conditions, approaches have been developed for phage preparations for clinical practice. Besides, they have shown several pitfalls, including low phage titration, inadequate endotoxin removal, high bacterial gross protein impurities, and the addition of toxic chemicals, etc. Therefore, the demand for high-quality and clinically safe phage preparations is increasingly required. Standardization and large-scale Good Manufacturing Practices (GMP) production of phage preparations will likely meet the growing demands for phage therapy. In addition, this will further promote drug approval of phage preparations in medicine by authority agency. Therefore, we develop this document to help the normalized and safe phage preparations.
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