UK Phage Therapy, 272 Bath Street, Glasgow G2 4JR, UK.
CPI, 1 Union Square, Central Park, Darlington DL1 1GL, UK.
Viruses. 2023 Mar 10;15(3):721. doi: 10.3390/v15030721.
Bacteriophage (phage) therapy is a promising alternative antimicrobial strategy with the potential to transform the way bacterial infections are treated. In the United Kingdom, phages are classed as a biological medicine. Although no phages are licensed for UK use, they may be used as unlicensed medicinal products where licensed alternatives cannot meet a patient's clinical needs. In the last 2 years, 12 patients in the UK have received phage therapy, and there is burgeoning clinical interest. Currently, clinical phage provision in the UK is ad hoc and relies upon networking with international sources of phages. The provision of phage therapy in the UK will not progress beyond an increasing number of ad hoc cases until an onshore sustainable and scalable source of well-characterised phages manufactured in accordance with Good Manufacturing Practice (GMP) is established. Here, we present an exciting new collaboration between UK Phage Therapy, the Centre for Phage Research at University of Leicester, CPI, and Fixed Phage. These partners, and others as we develop, will establish sustainable, scalable, and equitable phage therapy provision in the UK. We set out a vision for how phage therapy will be integrated into the NHS and healthcare more broadly, including the complementarity between licensed (cocktail) and unlicensed (personalised) phage preparations. Key elements of phage therapy infrastructure in the UK will be GMP phage manufacturing, a national phage library, and a national clinical phage centre. Together, this infrastructure will support NHS microbiology departments to develop and oversee phage therapy provision across the UK. As it will take time to deliver this, we also describe considerations for clinicians seeking to use unlicensed phage therapy in the interim. In summary, this review sets out a roadmap for the delivery of clinical phage therapy to the UK, the benefits of which we hope will reverberate for patients for decades to come.
噬菌体(噬菌体)治疗是一种有前途的替代抗菌策略,有可能改变治疗细菌感染的方式。在英国,噬菌体被归类为生物药物。尽管没有噬菌体获得英国使用许可,但在许可替代品无法满足患者临床需求的情况下,它们可以作为未许可的药物使用。在过去的 2 年中,英国有 12 名患者接受了噬菌体治疗,并且临床兴趣日益浓厚。目前,英国的临床噬菌体供应是临时性的,依赖于与国际噬菌体来源的联网。除非建立符合良好生产规范(GMP)制造的具有良好特征的噬菌体的陆上可持续和可扩展的来源,否则英国的噬菌体治疗供应将不会超出越来越多的临时病例。在这里,我们展示了英国噬菌体治疗、莱斯特大学噬菌体研究中心、CPI 和固定噬菌体之间令人兴奋的新合作。这些合作伙伴以及我们在开发过程中的其他合作伙伴,将在英国建立可持续、可扩展和公平的噬菌体治疗供应。我们提出了如何将噬菌体治疗纳入国民保健制度和更广泛的医疗保健的愿景,包括许可(鸡尾酒)和未许可(个性化)噬菌体制剂之间的互补性。英国噬菌体治疗基础设施的关键要素将是 GMP 噬菌体制造、国家噬菌体库和国家临床噬菌体中心。这些基础设施将共同支持英国国民保健制度微生物学部门在英国各地开发和监督噬菌体治疗的提供。由于这需要时间,我们还描述了临床医生在过渡期间寻求使用未许可噬菌体治疗的注意事项。总之,本综述为向英国提供临床噬菌体治疗制定了路线图,我们希望这将为未来几十年的患者带来好处。
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