The Magistral Phage

Abstract

Since time immemorial, phages—the viral parasites of bacteria—have been protecting Earth’s biosphere against bacterial overgrowth. Today, phages could help address the antibiotic resistance crisis that affects all of society. The greatest hurdle to the introduction of phage therapy in Western medicine is the lack of an appropriate legal and regulatory framework. Belgium is now implementing a pragmatic phage therapy framework that centers on the magistral preparation (compounding pharmacy in the US) of tailor-made phage medicines.

A century of bacteriophage research and applications: impacts on biotechnology, health, ecology and the economy!

“…A first official application or (re)implementation step has just been officially described and adopted by Belgium, whereas several neighboring countries actually have the intention to copy it . This pragmatic phage therapy framework centres on the ‘magistral preparation’ of tailor‐made phage medicines.…”

“…114,[118][119][120][121] A first official application or (re)implementation step has just been officially described and adopted by Belgium, whereas several neighboring countries actually have the intention to copy it. 122 This pragmatic phage therapy framework centres on the 'magistral preparation' of tailor-made phage medicines. In European law, a magistral preparation, called compounded prescription drug product in the USA, is defined as 'any medical product prepared in a pharmacy in accordance with a medical prescription for an individual patient'.…”

“…As such phage-therapy treatment is to be seen as a form of applying the principle of personalized medicine. 122 This allows also for ongoing discussions with the authorities to work on a widely adapted phage therapeutic framework and guidelines enabling better large-scale study designs, and exchange of genetic resources and phage strains based on the Nagoya Protocol (NP) and implementation in practice. [123][124][125][126]…”

Phage therapy for severe bacterial infections: a narrative review

“…Chosen phages can then be prepared for co‐administration by trained staff, like any other medicine, perhaps in a compounding pharmacy such as was once common in most hospitals. This latter concept is gaining prominence in Europe as a pathway to regulation, progressing particularly in Belgium and France, as the “magistral phage” approach …”

Phage therapy: Current status and perspectives

“…9 For example, in the United States acutely ill patients have been treated under emergency investigational new drug approval from FDA while Belgium has recently introduced "the magistral phage" approach allowing for production of personalized phage preparation at a pharmacy according to a physician's prescription. 10 A satisfactory safety and various level of success depending on type of infection, phage, and route of administration have been reported, mostly from Poland, Russia, and Georgia. 11 Recently, a new wave of successful cases of PT has also been reported from other European countries and the United States, where a first PT center has recently been established.…”