Critical Aspects of pH Measurement for Bacteriostatic Water for Injection.

Bacteriostatic water for injection (bWFI) is a common diluent for parenteral pharmaceutical products. bWFI is sterile water for injection containing one or more suitable antimicrobial agents to suppress the growth of microbial contaminants. United States Pharmacopeia (USP) monograph describes bWFI with pH ranging from pH 4.

Manufacturing Bacteriophages (Part 1 of 2): Cell Line Development, Upstream, and Downstream Considerations.

Within this first part of the two-part series on phage manufacturing, we will give an overview of the process leading to bacteriophages as a drug substance, before covering the formulation into a drug product in the second part. The principal goal is to provide the reader with a comprehensive framework of the challenges and opportunities that present themselves when developing manufacturing processes for bacteriophage-based products. We will examine cell line development for manufacture, upstream and downstream processes, while also covering the additional opportunities that engineered bacteriophages present.

Manufacturing Bacteriophages (Part 2 of 2): Formulation, Analytics and Quality Control Considerations.

Within this second piece of the two-part series of phage manufacturing considerations, we are examining the creation of a drug product from a drug substance in the form of formulation, through to fill-finish. Formulation of a drug product, in the case of bacteriophage products, is often considered only after many choices have been made in the development and manufacture of a drug substance, increasing the final product development timeline and difficulty of achieving necessary performance parameters. As with the preceding review in this sequence, we aim to provide the reader with a framework to be able to consider pharmaceutical development choices for the formulation of a bacteriophage-based drug product.