14
Good Manufacturing Practice standards remain essential for high-quality phage production and biobanks
Recommendation
The set of consensus high standards for pharmaceutical production, known as Good Manufacturing Practice (GMP), should continue to be required in the UK for high quality phages manufactured for generic products targeting the most common bacterial pathogens. It should also underpin the production of phage biobanks to be accessed at short notice by clinicians providing assurance to both clinicians and patients that phages from biobanks will be of the highest standard of safety and purity. Access to phages manufactured to GMP standards will also allow microbiology laboratories to deal with less common pathogens and tailor phages to be more effective for individual patients when a more agile precision medicine approach is required. However, there may still be a place for non-GMP phages in instances when non-banked phages are needed at short notice for compassionate use as a last resort and can be produced via collaboration between a physician and pharmacist—as in Belgium.
Paragraph Reference
78
Government Response
A response document is linked to this report, dated 1 March 2024. Response attribution to this conclusion has not been verified. Read the response document.
Source
Report
First Report - The antimicrobial potential of bacteriophages
03 Jan 2024
HC 328
Addressee Bodies
Department for Science, Innovation and Technology
Timeline
Recommendation age
2.7 yrs
Report published
03 Jan 2024