It is well documented that the discovery and successful development of small-molecule antibiotics combined with a lack of rigour in product validation was at least partially responsible for the failure of phage therapy to take hold in Western countries. Despite this, several large pharmaceutical companies have previously sold therapeutic phage products; however, in the West in recent years, few if any phage products have been available. The current resurgence of interest in phage therapy has resulted in several non-therapeutic phage products being sold and a number of early-stage clinical trials have been, or are being conducted. Importantly, a number of relatively well-financed companies are now active in the field.
While there is some renewed interest from large corporations in the use of phages in a number of product areas, the bulk of commercial phage development is being carried out by Small and Medium Enterprises (SMEs). All life science-focussed SMEs face substantial hurdles, particularly when developing human therapeutics but it could be argued that in the case of phage, some of these issues are particularly pronounced. Specific key issues include:
i) Patents – the lengthy historical use of phage therapy means that in many cases the core technologies (particularly the cocktails themselves) are difficult to protect.
ii) Purification – there are relatively standard purification methodologies available for small molecules. Being biological entities, phages are unique and process development, assay validation and industrial scale-up are relatively poorly understood by many contract research organisations.
iii) Regulation – regulatory pathways (particularly in the case of therapeutics) are often not compatible with the unique nature of bacteriophage products, potentially making any regulatory interactions riskier.
This presentation will discuss these and other issues facing small phage companies and consider some ways in which these issues have been or can be addressed.