Success in Bacteriophage Commercialisation: Key Considerations

In the ever-evolving biotech landscape, the utility and effectiveness of bacteriophages are gaining significant attention for several applications across an expanse of sectors. The escalating global concern about antibiotic resistance and the dwindling effectiveness of conventional antibacterial strategies are fuelling the rising demand for bacteriophage-based products. With a natural proficiency for bacterial eradication and their potential to be engineered, bacteriophages offer novel and highly customisable approaches in applications from healthcare to agriculture and beyond. This article delves into the complexities of commercialising bacteriophage-based solutions, elucidating the key considerations that can contribute to the successful market entry and adoption of these innovative bio-tools. 

Understanding Bacteriophages

Bacteriophages are abundant viruses that selectively infect and kill bacteria. Phages have many advantageous properties including high host specificity, genetic tractability, inherent non-toxicity to humans, animals, and plants, auto-dosing properties, and large surface-bearing capacity, which render them useful for a range of applications. Bacteriophages have been harnessed by scientists for applications within human and animal health, agriculture, aquaculture, industry, and environmental sciences, among others. 

FixedPhage’s Approach to Bacteriophage Commercialisation

FixedPhage’s innovative technology irreversibly binds phage to almost any surface, and stabilises it, extending the natural antibacterial properties of phage from days to years and opening the door to their widespread practical applications. FixedPhage uses corona discharge to enhance the wettability of the substrate surface onto which the bacteriophages are applied. Bacteriophages are then bound to the surface irreversibly. This method of plasma-based immobilisation is not only time- and cost-effective, but it is also far more environmentally friendly than chemical immobilisation.

FixedPhage’s phage immobilisation technology comes in several forms, each specialised for particular applications, including health and agriculture: 

• mediPHIX™ solutions address bacterial challenges across the human health sector. Use cases include enabling efficient wound care, effectively treating skin conditions, and safe vascular grafts.
• aquaPHIX™ solutions enhance aquaculture outcomes. Studies have shown that coating fish food with an aquaPHIX™ solution sustainably improved aquaculture outcomes.
• farmPHIX™ solutions can be added to water supplies or feed to promote healthier livestock by addressing microbial problems without the need for harmful, unsustainable antibiotics and/or chemicals.
• petPHIX™ solutions are aimed at eliminating bacterial infections in companion animals with bacteriophage solutions in the form of topically applied gels or creams.

In addition to these solutions, FixedPhage also offers solutions for personal health, harvest health, and process health. 

Regulatory Challenges in Bacteriophage Commercialisation

Despite their promise in several applications, the commercialisation of bacteriophage-based products for use in human and animal health is rife with challenges. The regulatory landscape is ever-changing, and there is a lack of clear regulatory guidelines or processes. There is currently a push for better regulatory guidelines, and a collaborative effort involving UK Phage Therapy, CPI, FixedPhage, and the University of Leicester’s Centre for Phage Research is working to establish a novel infrastructure for the provision of phage therapy in the UK.

Bacteriophages are classed as biological medicines in the UK, which presents several hurdles in itself. This means that, before obtaining regulatory approval, phages must adhere to a stringent regulatory process including preclinical testing, clinical trials, and a review by the Medicines and Healthcare Products Regulatory Agency (MHRA). The considerable challenges in obtaining robust, properly-controlled clinical trial data for bacteriophage-based products represent a huge hurdle in this area. In addition, phages must be produced in adherence to Good Manufacturing Practices (GMP), which also poses a barrier to their sustainable production at the scale required for commercialisation.

Intellectual Property Considerations for Bacteriophage Commercialisation

Similarly, navigating the intellectual property (IP) landscape for bacteriophage-based products presents a unique set of challenges. Because bacteriophages are naturally occurring substances, their patentability often relies on significant modification or novel usage. Furthermore, their high specificity and evolutionary nature may complicate attempts at broad patent protection and consistent reproducibility – key aspects of the patenting process. Enforcing patents can also be difficult, given potential competitors’ claims about prior knowledge or usage. Some companies may opt for trade secret protection over patents, maintaining confidentiality around proprietary phage cocktails or production processes, though this requires rigorous internal controls. Additionally, the ever-evolving and challenging regulatory guidelines for bacteriophage product approval could impact IP strategies.

FixedPhage currently holds a total of 37 patents, across the classifications of pharmaceuticals, biotechnology, foods and drinks, basic materials chemistry, medical technology, environmental technology, and chemical engineering. 

Market Analysis: Demand for Bacteriophage-Based Products

Despite being in its infancy, the market for bacteriophage-based products has significant potential for rapid growth. The current global bacteriophage market is valued at $43 M (USD) and is projected to reach $68 M by 2033. Several factors are driving this growth, including the increasing urgency of the antibiotic resistance crisis, increasing awareness and acceptance among the public and healthcare professionals, improving regulatory support from government agencies, and ongoing research and development activities fuelled by novel funding initiatives. For example, FixedPhage recently secured a £1.5 M investment to further scale the development and commercialisation of bacteriophage technology for animal and veterinary health applications.

Successful Strategies for Commercialising Bacteriophage-Based Products

Successfully commercialising bacteriophage-based products hinges on a multidimensional strategy. Forging partnerships and collaborations,

 particularly between academic institutions and biotech firms, can accelerate research, bolster resources, and improve market credibility. A prime example of this is FixedPhage’s partnership with UK Phage Therapy, CPI, and the University of Leicester’s Centre for Phage Research. 

It is also essential to navigate market entry effectively – this could involve focusing on markets where bacteriophage products can provide unique value to an area of critical importance, such as addressing antibiotic-resistant infections in the current antibiotic resistance crisis, or offering more sustainable solutions in the era of climate change and increased environmental action. 

Case Studies: Commercialisation Success Stories

Since its inception in 2010, FixedPhage has become a pioneer in the area of bacteriophage commercialisation. Notable examples of successful bacteriophage commercialisation include FixedPhage’s aquaPHIX™ solutions, which were used in an international and multi-disciplinary collaborative project aiming at preventing bacterial infections in fish ponds; immobilising bacteriophage onto fish feed was shown to be a viable preventative measure against aquaculture bacterial disease.

Another successful case study is freshPHIX™ which enables phages to be immobilised onto food packaging. A trial showed that using freshPHIX™ technology increased the shelf life of bagged spinach, a considerable advantage considering the significant losses in terms of produce and finances caused by food waste as a result of spoilage. 

Conclusion

Successfully commercialising bacteriophage-based products involves navigating complex regulatory landscapes, securing robust IP protection, and creating strategic market entry and distribution plans. The success of companies like FixedPhage demonstrates that these challenges can be met, by leveraging strategic partnerships and niche markets. With a growing demand for alternative antibacterial solutions and a notable rise in antibiotic resistance, the future of bacteriophage commercialisation in the UK holds promise.