Bacteriophages (phages) are viruses that specifically target and eliminate bacteria. They have been used as antimicrobial agents for over a century, notably in the former Soviet Union. Unfortunately, the differences between Soviet medical practice and reporting of clinical data and the current regulatory standards upheld by Western countries make it impossible to draw any conclusions about the safety and efficacy of phage therapy, without additional high-quality studies. However, due to the global increase in antimicrobial resistance, the potential of phages as a viable alternative treatment strategy has gained more interest in the last two decades, encouraging research in the field.
In Belgium, more than a hundred patients have already benefited from phage therapy. Although the initial treatments were administered under the provisions of Article 37 of the Declaration of Helsinki (Unproven Interventions in Clinical Practice), the majority of patients received phage treatment thanks to a novel, dedicated regulatory framework established in 2018, known as “The Magistral Phage”. This pragmatic personalized therapy approach allows the use of phage products as active pharmaceutical ingredients (API) in a magistral preparation, specifically designed for an individual patient. The process necessitates the certification of the product, which includes a genomic passport of the phage and a quality control of the product batch, by a laboratory recognized by the national health authority.
Our presentation will delve into five years of experience with the quality control (QC) of therapeutic phage products intended as API. We will illustrate the current flow chart of the certification process employed in Belgium, based on the findings from more than 60 batches of phage productions. The choice of approaches and methodologies for genetic analyses and pyrogenicity assessment will be discussed, and potential future developments, supported by data generated through ongoing research projects, will be addressed. Advances in technology and methodology, guided by regulations such as the upcoming general chapter 5.31 in the European Pharmacopoeia, will play a key role in refining QC processes. Ultimately, this will enhance the reliability of phage therapy products, paving the way for their wider acceptance in the medical community.
