Abstract
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. The intent is to sensitize and highlight the tradeoffs that are necessary in the development of a finished drug product, and to be able to take the entire spectrum of tradeoffs into account, starting with early-stage R&D efforts. Furthermore, we are arming the reader with an overview of historical and current analytical methods with a special emphasis on most relevant and most widely available methods. Bacteriophages pose some challenges that are related to but also separate from eukaryotic viruses. Last, but not least, we close this two-part series by briefly discussing quality control (QC) aspects of a bacteriophage-based product, taking into consideration the opportunities and challenges that engineered bacteriophages uniquely present and offer.
Highlights
Received: 7 August 2021Accepted: 31 August 2021Published: 2 September 2021Publisher’s Note: MDPI stays neutral with regard to jurisdictional claims in published maps and institutional affiliations.Licensee MDPI, Basel, Switzerland.Historically, much of the formulation process for phages has been an adaptation of what is already known for protein-based therapeutics [1]
The formulation plays a key role in drug delivery, as well as ensuring drug stability over long periods of time, and it is not different for bacteriophage-based therapies
In order to choose the optimal ingredients for a phage therapy formulation, on top of considerations regarding the phage itself, ingredients must always be safe to use in the context of a particular delivery mode, e.g., some ingredients can be safe for oral delivery but not for inhalation delivery [1]
Summary
Publisher’s Note: MDPI stays neutral with regard to jurisdictional claims in published maps and institutional affiliations. Much of the formulation process for phages has been an adaptation of what is already known for protein-based therapeutics [1]. Considering the broad possible applications for phages in the clinical setting, it is important to think about how to ensure the best delivery of the phages to their target site. The formulation plays a key role in drug delivery, as well as ensuring drug stability over long periods of time, and it is not different for bacteriophage-based therapies. Several authors have been investigating the possible formulations that can be designed for phage therapy and how to improve its long-term stability.
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