Bacteriophage Manufacturing: From Early Twentieth-Century Processes to Current GMP

Abstract

Recent clinical progress in the field of phage therapy has led to an increased demand for pharmaceutical grade bacteriophages, manufactured under Good Manufacturing Practices (GMP) conditions and approved by regulatory agencies. However, even if the development of a common standardized process for phage production seems rational, there are no guidelines to pave to way for manufacturing. This chapter reviews phage therapy through the lens of modern medicinal guidelines. It lists manufacturing strategies that can be used for phage production. Finally, it stands quality controls that can be applied to release phage-based drug products in compliance with the latest regulatory requirements.