Bacteriophage therapy
Figure 5
The ‘Prêt -à- Porter’ and ‘Sur - mesure’ Models of Phage Therapy figure features a comparison between the process of developing pre- defined and Note. This personalized PTMPs. This figure is not covered by the Creative Commons (CC) Attribution 4.0 International License. Reprinted by permission from Springer Nature: Pharmaceutical Research, The Phage Therapy Paradigm: Prêt-à-Porter or Sur- mesure? Jean-Paul Pirnay et al. (2011), all rights reserved.
Such regulatory guidelines were initially designed mainly for the development of antibiotics and other uniform industrial medicinal products. The GMPs require a series of systematic, controlled, and standardized procedures that best suit the production of uniform products: in the context of phages, a specific phages species. As mentioned before, due to the fact that phage resistance is relatively common and scientifically inevitable if immutable therapeutic agents are used in the long term, it realistically suggests that once the bacterial target develops resistance to one or several specific phage species, the massive series of costly and time-consuming procedures established under GMP standards for the manufacturing of that fixed phage product becomes worthless. Taking this into consideration, it might be more advisable to selectively apply certain phages from extensive phage collections (in laboratories so as to ensure the quality) rather than adhering to GMP production standards. In response to the discrepancy, two paradigms of the potential approaches of phage therapy (Fig. 5), ‘prêt -à-porter (ready-to- use)’ and ‘sur - mesure (tailored)’ were proposed by Pirnay et al. in a 2010 study after the First International Congress on Viruses of Microbes held at the Pasteur Institute in Paris the same year. Currently, PTMPs are either pre-defined medicines with non-variable components designed for large- scale distribution under the concept of the ‘prêt -à- porter’ model or personal ized, patient- specific with flexible compositions according to the ‘sur - mesure’ model. 60 Since the treatment is essentially tailored for one particular patient, and it would be impossible to involve a large number of clinical subjects with precisely the same specific type of infection, it can be clearly concluded that it is notably difficult for personalized phage preparations to complete a series of RCTs, albeit undeniably essential and necessary to ensure maximum safety and efficacy. Under the concept of GMPs and the
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