The book provides detailed insight into the current state of knowledge on the therapeutic use of bacteriophages in a variety of settings. The authors bring practical, expert knowledge within their respective fields and provide an excellent interdisciplinary overview of the potential and actual application of phage therapy. The publication is a valuable resource for those involved in the non-medical application of novel phage therapies.
The global health threat of increasing antibiotic-resistant bacteria has generated interest in the potential of phage therapy in public health care. The potential phage industry requires supportive research to develop scalable and cost-effective processes for the manufacture of phage products, as well as the development of stable pharmaceutical regulations incorporating aspects of controlled release and targeted delivery to meet infectious disease management needs.
The increasing prevalence of infections with pathogenic bacteria resistant to many drugs has led to renewed interest in bacteriophage therapy as an alternative to antibiotics. The regulation of bacteriophage products for therapy the United States by the Center for Biologics Evaluation and Research at the Food and Drug Administration, although similar in many ways to the regulation of other biologic drugs, requires some unique approaches. In the chapter ‘Regulatory Considerations for Bacteriophage Therapy Products’, Roger D. Plaut and Scott Stibitz (Center for Biologics Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA) review the institutions of regulatory oversight of biological products, new drug application research, and the expansion of access to them, while also discussing the administrative and regulatory arrangements for the manufacture and control of bacteriophage products.
Phage therapy is an experimental treatment for antibiotic-resistant bacterial infections. Patients can gain access to this therapy by participating in a clinical trial or during so-called compassionate treatment. Doctors Jan Borysowski (Institute of Legal Sciences, Polish Academy of Sciences) and Andrzej Górski (Ludwik Hirszfeld Institute of Immunology and Experimental Therapy, Polish Academy of Sciences), in the chapter ‘Ethics of Phage Therapy’, discuss the main issues related to the ethics of clinical trials and compassionate use of phage therapy. The discussion of compassionate use focusses on whether phage therapy is consistent with the four main principles of medical ethics, including harmlessness, beneficence, justice and respect for patient autonomy. The authors also address ethical guidelines that may be helpful to physicians considering compassionate phage therapy.
Bacteriophages (phages in short) are increasingly viewed as a potential additional tool to combat the global antibiotic crisis. Conducting the necessary clinical trials to verify their efficacy and optimise clinical application protocols is hampered by the persistent lack of regulation over the years. Daniel De Vos, Jean-Paul Pirnay (Laboratory for Molecular and Cellular Technology Queen Astrid Military Hospital, Brussels, Belgium), Gilbert Verbeken (QA/QC and regulatory affairs, Laboratory for Molecular and Cellular TechnologyQueen Astrid Military Hospital, Brussels, Belgium) and Johan Quintens (Vésale Bioscience, Noville sur Mehaigne, Belgium) in the chapter ‘Phage therapy in Europe: Regulatory and intellectual property protection issues’ discuss the current administrative and legal status in Europe with respect to the two most significant barriers to phage therapy: regulatory issues and intellectual property protection.
Successful clinical trials of phage therapy leading to regulatory approval will accelerate the need for product differentiation and innovation. In the publication by Maia Merabishvili, Jean-Paul Pirnay (Laboratory for Molecular and Cellular TechnologyQueen Astrid Military Hospital, Brussels, Belgium), Kilian Vogele (Systems Biophysics and Bionanotechnology-E14, Physics-Department and ZNNTechnische Universität München Garching, Germany) and Danish J. Malik (Chemical Engineering Department Loughborough University, UK) in the chapter ‘Production of phage therapeutics and formulations: Innovative approaches’ present innovative approaches related to the production of phage drugs, including pharmaceutical formulations suitable for applications in various medical fields, including veterinary and clinical medicine, rapid diagnostics, food safety and biological control. An international team of researchers evaluated the potential benefits of introducing synthetic biology methods for phage drug production.
The book is divided into five main topics:
- Bacteriophages as antibacterial agents
- Bacteriophages and the immune system
- Use of bacteriophages to combat bacterial infections
- Bacteriophage-derived antibacterial agents
- Phage therapy: Regulatory and ethical aspects
The innovative study was prepared as part of the work carried out by the Centre for Research on the Integrity of Science at the Institute of Legal Sciences of the Polish Academy of Sciences. It addresses ethical and legal issues surrounding bacteriophage therapy products as well as the issue of legal regulation (also in terms of intellectual property protection) of phage therapy in Europe.
The authors adopted a broad comparative legal research perspective referring to the legal regulations in the United States of America.
Wydanie: Warszawa 2019
Ilość stron: 385
Monografia dostępna online