Robust Approaches for the Production of Active Ingredient and Drug Product for Human Phage Therapy
| Autor: | Lorenzo Corsini, Michele Mutti |
|---|---|
| Jazyk: | angličtina |
| Rok vydání: | 2019 |
| Předmět: |
Microbiology (medical)
phage therapy bacteriophages antibiotic resistance Phage therapy quality by design Computer science Process (engineering) media_common.quotation_subject medicine.medical_treatment Mini Review lcsh:QR1-502 Microbiology Quality by Design lcsh:Microbiology Bacteriophage 03 medical and health sciences Documentation phage purification medicine PhagoMed Quality (business) 030304 developmental biology media_common Active ingredient 0303 health sciences biology 030306 microbiology biology.organism_classification Clinical trial Risk analysis (engineering) |
| Zdroj: | Frontiers in Microbiology Frontiers in Microbiology, Vol 10 (2019) |
| ISSN: | 1664-302X |
| Popis: | To be successful, academic and commercial efforts to reintroduce phage therapy must ensure that only safe and efficacious products are used to treat patients. This raises a number of manufacturing, formulation, and delivery challenges. Since phages are biologics, robust manufacturing processes will be crucial to avoid unwanted variability in each step of the process. The quality standards themselves need to be developed, as patients are currently being treated with phages produced under quality standards ranging from cGMP for clinical trials in EMA and FDA regulated environments to no standards at all in some last resort treatments. In this short review, we will systematically review the literature covering technical issues and approaches to increase robustness at every step of the production process: the identity of the phage and bacterial production strains, the fermentation process and purification, the formulation of the drug product, the quality controls and the documentation standards themselves. We conclude that it is possible to control cost at the same time, which is critical to re-introduce phage therapy to western medicine. |
| Databáze: | OpenAIRE |
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