The Challenges and Opportunities of Bacteriophage Research
Bacteriophages are viruses that specifically target and destroy pathogenic bacteria, making them a promising research topic with significant implications for human health and the environment. Bacteriophage-based solutions can be applied to several biological and ecological problems, including treating bacterial infections in humans and animals, improving wastewater treatment sustainability, and enhancing food safety.
However, the world of bacteriophage research is fraught with challenges and opportunities as scientists race to unlock their full potential. Fixed Phage is at the forefront of innovation in this rapidly evolving field, making strides in developing innovative phage-based solutions to tackle some of the most pressing healthcare and environmental issues of our time. In this article, we will delve into the fascinating realm of bacteriophage research, exploring its complexities and the promising prospects it holds for the future.
Current State of Bacteriophage Research
Though bacteriophage therapy is still in its infancy, the urgent need to address the antibiotic crisis, coupled with the climate crisis, has heightened interest in bacteriophage research globally. Researchers are investigating the potential of bacteriophages in various applications and, although significant progress has been made, several challenges remain to be addressed with fundamental research. This includes the identification and characterisation of novel phages, the characterisation of their complex interactions with the gut microbiome, and the determination of the mechanisms of phage resistance in bacteria. However, the biggest obstacle to phage therapy is the lack of validated, appropriately controlled clinical trial data supporting its safety and efficacy for therapeutic use in humans. Phage therapy trials are resource intensive and trial design is challenging due to their inherent properties: phages are highly specific and generally need to be personalised. They also have “auto-dosing” properties, meaning it is difficult to control dosage, and are inherently unstable, posing storage issues.
Despite these challenges, the future of bacteriophage research has an abundance of opportunities. Rapid advances in molecular biology, genomics, and bioinformatics provide researchers with powerful tools for understanding phage-bacteria interactions and engineering phages for specific purposes. A growing interest in the field has led to increased funding and collaborative efforts among academia, industry, and government agencies, accelerating the development of novel phage-based solutions. For example, a collaborative effort involving UK Phage Therapy, CPI, Fixed Phage, 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.
Regulatory Framework for Bacteriophage Research
In the UK, bacteriophages are classed as biological medicines and must follow a stringent regulatory process that includes preclinical testing, clinical trials, and a review by the Medicines and Healthcare Products Regulatory Agency (MHRA). For approval in the UK, phages must be manufactured according to Good Manufacturing Practice (GMP) guidelines, which currently pose a barrier to their sustainable, scalable production. Currently, no phages are licensed for medical use in the UK but unlicensed phages can be used therapeutically where licensed alternatives have not produced the desired outcome (i.e. in cases where antibiotics have failed to combat a bacterial infection).
However, as awareness and interest in bacteriophage therapy grow, there may be a push to design novel regulatory frameworks that consider bacteriophages’ unique properties and provide a more efficient roadmap for the broad delivery and adoption of phage therapy. As bacteriophage therapy gains traction worldwide, there may be opportunities for increased international collaboration on regulatory frameworks, which currently vary across regions, helping to streamline the approval process and facilitate the global development and distribution of bacteriophage therapies and other bacteriophage-based solutions.
Funding Landscape for Bacteriophage Research
Funding sources for bacteriophage research vary widely, including government agencies, non-profit organisations, academic institutions, and private industry. However, a significant challenge is the competition for limited resources with other fields of biomedical research. Additionally, bacteriophages’ unique properties may present obstacles in securing funding for projects that require non-traditional approaches or infrastructure. There is also a need to demonstrate the safety and efficacy of bacteriophage therapy to attract funding, which can be difficult due to the lack of compelling clinical evidence.
Nevertheless, as antibiotic resistance becomes an increasingly critical global health issue, funding opportunities for bacteriophage research are likely to expand. Recently, the UKRI committed £6 million of funding to bacteriophage research, whilst the NIH awarded $2.5 million. International collaborations and partnerships between academic institutions, government agencies, and private industry may facilitate the development of novel funding models and resources to support bacteriophage research. Moreover, increased public awareness of the benefits of bacteriophages may encourage investment from non-profit organisations and private industry. Finally, successful clinical trials and regulatory approval of bacteriophage-based therapies may pave the way for additional funding opportunities and expanded research in this promising field.
Bacteriophages in Action
While bacteriophage therapy has not yet become a mainstream treatment option, there have been several notable cases of successful treatment of infections and infectious diseases using bacteriophages. Recently, phage therapy was used to treat diabetes patients suffering from difficult-to-treat foot infections, with promising results. In October 2022, a clinical trial commenced, aiming at investigating the safety and efficacy of phage cocktails for treating P. aeruginosa infections, which are commonly multidrug-resistant infections acquired in hospitals, in the lungs of patients with cystic fibrosis. Phage therapy is not only used for treating human infections; a case study highlighted the possibility of preventing bacterial infections in fish ponds by immobilising phage onto fish food with Fixed Phage technology. Phages have also shown potential in agriculture (controlling infectious diseases in plants and animals), aquaculture, wastewater treatment, extending product shelf life by treatment of packaging, acne treatment, food safety, and drug delivery, as well as acting as biosensors.
Despite numerous successes, the remaining challenges prevent bacteriophage-based products from being scaled up more broadly. However, as research advances and awareness of the benefits of bacteriophage therapy increases, associated challenges are likely to be overcome, creating more possibilities for phages across a range of applications.
Conclusion and Future Perspectives
Bacteriophage research offers opportunities for developing novel therapies as antibiotic alternatives, as well as solutions to other pressing problems. However, challenges in securing funding, navigating regulatory frameworks, and scaling up production hinder widespread adoption. Collaborative efforts and increased funding opportunities could help overcome current obstacles and revolutionise our approach to bacterial infections and other areas where bacteria play a critical role.
FixedPhage has a proven track record in developing innovative solutions for a diverse array of applications. Reach out to find out more about our ongoing research or discuss potential partnerships.
