Robust Approaches for the Production of Active Ingredient and Drug Product for Human Phage Therapy
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...
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Frontiers Media S.A.
2019-10-01
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| Series: | Frontiers in Microbiology |
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| Online Access: | https://www.frontiersin.org/article/10.3389/fmicb.2019.02289/full |
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doaj-2cd608459d83417098cc90e91e04b8f72020-11-25T02:49:24ZengFrontiers Media S.A.Frontiers in Microbiology1664-302X2019-10-011010.3389/fmicb.2019.02289465742Robust Approaches for the Production of Active Ingredient and Drug Product for Human Phage TherapyMichele MuttiLorenzo CorsiniTo 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.https://www.frontiersin.org/article/10.3389/fmicb.2019.02289/fullphage therapyquality by designPhagoMedbacteriophagesantibiotic resistancephage purification |
| collection |
DOAJ |
| language |
English |
| format |
Article |
| sources |
DOAJ |
| author |
Michele Mutti Lorenzo Corsini |
| spellingShingle |
Michele Mutti Lorenzo Corsini Robust Approaches for the Production of Active Ingredient and Drug Product for Human Phage Therapy Frontiers in Microbiology phage therapy quality by design PhagoMed bacteriophages antibiotic resistance phage purification |
| author_facet |
Michele Mutti Lorenzo Corsini |
| author_sort |
Michele Mutti |
| title |
Robust Approaches for the Production of Active Ingredient and Drug Product for Human Phage Therapy |
| title_short |
Robust Approaches for the Production of Active Ingredient and Drug Product for Human Phage Therapy |
| title_full |
Robust Approaches for the Production of Active Ingredient and Drug Product for Human Phage Therapy |
| title_fullStr |
Robust Approaches for the Production of Active Ingredient and Drug Product for Human Phage Therapy |
| title_full_unstemmed |
Robust Approaches for the Production of Active Ingredient and Drug Product for Human Phage Therapy |
| title_sort |
robust approaches for the production of active ingredient and drug product for human phage therapy |
| publisher |
Frontiers Media S.A. |
| series |
Frontiers in Microbiology |
| issn |
1664-302X |
| publishDate |
2019-10-01 |
| description |
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. |
| topic |
phage therapy quality by design PhagoMed bacteriophages antibiotic resistance phage purification |
| url |
https://www.frontiersin.org/article/10.3389/fmicb.2019.02289/full |
| work_keys_str_mv |
AT michelemutti robustapproachesfortheproductionofactiveingredientanddrugproductforhumanphagetherapy AT lorenzocorsini robustapproachesfortheproductionofactiveingredientanddrugproductforhumanphagetherapy |
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