Spray-dried anti-Campylobacter bacteriophage CP30A powder suitable for global distribution without cold chain infrastructure

Carrigy, Nicholas B.; Liang, Lu; Wang, Hui; Kariukic, Samuel; Nagel, Tobi E .; Connerton, Ian F.; Vehringa, Reinhard

Abstract

Campylobacter jejuni is a leading cause of foodborne illness globally. In this study, a spray drying and packaging process was developed to produce a thermally-stable dry powder containing bacteriophages that retains biological activity against C. jejuni after long distance shipping at ambient temperature. Spray drying using a twin-fluid atomizer resulted in significantly less (p < 0.05) titer reduction than spray drying using a vibrating mesh nebulizer. The use of centrifugation and dilution of filtered bacteriophage lysate in the formulation step resulted in a significantly greater (p < 0.05) proportion of bacteriophages remaining active relative to use of no centrifugation and dilution. The spray-dried bacteriophage powder generated using leucine and trehalose as excipients was flowable, non-cohesive, and exhibited a high manufacturing yield. The powder retained its titer with no significant differences (p > 0.05) in biological activity after storage in suitable packaging for at least 3 weeks at room temperature and after ambient temperature shipping a total distance of approximately 19,800 kilometers, including with a 38°C temperature excursion. The bacteriophage powder therefore appears suitable for global distribution without the need for cold chain infrastructure.

Citation

Carrigy, N. B., Liang, L., Wang, H., Kariukic, S., Nagel, T. E. .., Connerton, I. F., & Vehringa, R. (2019). Spray-dried anti-Campylobacter bacteriophage CP30A powder suitable for global distribution without cold chain infrastructure. International Journal of Pharmaceutics, 569, Article 118601. https://doi.org/10.1016/j.ijpharm.2019.118601

• Journal Article Type: Article
• Acceptance Date: Aug 3, 2019
• Online Publication Date: Aug 5, 2019
• Publication Date: Oct 5, 2019
• Deposit Date: Aug 7, 2019
• Publicly Available Date: Aug 6, 2020
• Journal: International Journal of Pharmaceutics
• Print ISSN: 0378-5173
• Electronic ISSN: 1873-3476
• Publisher: Elsevier
• Peer Reviewed: Peer Reviewed
• Volume: 569
• Article Number: 118601
• DOI: https://doi.org/10.1016/j.ijpharm.2019.118601
• Keywords: Pharmaceutical Science
• Public URL: https://nottingham-repository.worktribe.com/output/2400878
• Publisher URL: https://doi.org/10.1016/j.ijpharm.2019.118601
• Additional Information: This article is maintained by: Elsevier; Article Title: Spray-dried anti-Campylobacter bacteriophage CP30A powder suitable for global distribution without cold chain infrastructure; Journal Title: International Journal of Pharmaceutics; CrossRef DOI link to publisher maintained version: https://doi.org/10.1016/j.ijpharm.2019.118601; Content Type: article; Copyright: © 2019 Elsevier B.V. All rights reserved.
• Contract Date: Aug 7, 2019