Bridging the gap: Phage manufacturing processes from laboratory to agri-food industry.

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Interest in bacteriophages (phages) as sustainable biocontrol agents in the agri-food industry has increased because of growing worries about food safety and antimicrobial resistance (AMR). The phage manufacturing process is examined in this review, with particular attention paid to the crucial upstream and downstream processes needed for large-scale production. Achieving large phage yields requires upstream procedures, including fermentation and phage amplification. In the meantime, downstream procedures, including purification, endotoxin removal, and formulation, is essential for guaranteeing product quality and regulatory compliance. Despite advances in upstream and downstream process optimization of phage production processes, these methods are not effectively utilized in manufacturing processes. Additionally, the commercialization of phage products is hindered by fragmented rules and inconsistent regulations. Emerging technologies such as enhanced chromatography, continuous processing, and encapsulating techniques provide prospects for increased stability, efficiency, and scalability to fill these gaps. Furthermore, by facilitating real-time process optimization, predictive quality control (QC), and unique phage product creation, the integration of artificial intelligence (AI) and machine learning has the potential to transform the phage manufacturing industry completely. In order to provide consistent standards, encourage innovation, and bridge the gap between academic research and commercial applications, this review identifies gaps and highlights the necessity of cooperation between academia, industry, and regulatory agencies. To effectively utilize phages' potential to improve food safety, fight AMR, and promote sustainable agricultural practices, the agri-food industry must advance phage manufacturing techniques and harmonize regulatory frameworks.