About this Research Topic
Against a backdrop of global antibiotic resistance and increasing awareness of the importance of the human microbiota, there has been a resurgent interest in the potential use of bacteriophages for therapeutic purposes, known as phage therapy. Recently concluded phage therapy clinical trials including the Nestlé trial to treat Escherichia coli associated diarrhoea in children and the PhagoBurn effort by Pherecydes Pharma to treat Pseudomonas aeruginosa infections in burn wounds have highlighted major manufacturing, formulating and delivering challenges that need to be urgently addressed.
Flexible modern scalable production approaches are needed to supply clinicians with phage products of suitable quality and stability to treat patients under companionate use and for new clinical trials in order to demonstrate the considerable potential of bacteriophage therapy. The alignment of phage therapy along the personalized precision medicine route and the recent call in Belgium for phages to be used as magistral preparations with quality approved laboratories manufacturing phages following a monograph and then being formulated by a pharmacist opens the possibility for greater flexibility in the future. The need to scale out production to multiple manufacturing sites or near the patient within healthcare settings may require novel manufacturing approaches that are compliant from a regulatory point of view.
This Research Topic encourages original research articles addressing bacteriophage manufacturing (including cGMP manufacture) and formulation challenges to meet key quality attributes, those arising from personalized medicine phage therapies and to ensure that phage preparations are safe and fit for purpose. Novel approaches (e.g. cell-free production systems) and methods covering aspects related to scalable industrial-scale production and downstream purification of bacteriophages (e.g. to remove endotoxin) would be welcome. Research articles are solicited focusing on phage formulation aiming to improve the storage stability of phage preparations or encapsulation and immobilization in micro- or nanostructured materials for targeted delivery and controlled release applications.
Dr. Grégory Resch is currently a member of the advisory board of PhagoMed GmbH.
Keywords: cGMP, Antimicrobial Resistance, Bacteriophage, Phage Therapy, Phage Manufacturing, Phage Preparation stability, Formulation, Magistral Preparations, Personalised Medicine, Controlled Release
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