Sterile Manufacturing of Drug Products and Their Applications to Bacteriophages

Sterile manufacturing is multifaceted. Each aspect seeks to improve the process of producing drug products absent of impurities. Bacteriophages can benefit greatly from sterile manufacturing which would amplify their already vast range of applications. Novel bacteriophage discovery and annotation, implemented within a classroom setting, can aid in building the foundation of bacteriophages for use in clinical applications. High-Performance Liquid Chromatography (HPLC) can detect impurities and test compatibilities in the final product. Oxytocin and its interaction with tranexamic acid (TXA) provide an excellent example of how HPLC use can be critical in sterile manufacturing as well as build a baseline for which bacteriophages may be utilized in sterile production. A quality scorecard for drug products provides an additional metric that can be used by governing agencies and consumers to analyze drug products of similar bioequivalence and subsequently grade them. The development of a scorecard will provide a guideline to improve the sterile manufacturing of drug products and biologics such as bacteriophages. A literary analysis of lipid nanoparticles presents a future application for synthetically manufactured bacteriophages. The conclusions gathered from this work can be utilized as a case study for working professionals who aim to implement advancements in sterile manufacturing within their industry.