Journal
BIOLOGICALS
Volume 44, Issue 2, Pages 69-72Publisher
ACADEMIC PRESS LTD- ELSEVIER SCIENCE LTD
DOI: 10.1016/j.biologicals.2015.12.001
Keywords
Biopharmaceuticals; Freeze-drying; Long-term storage; HBV; Plant-derived oral vaccine; S-HBsAg
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Funding
- Polish Ministry of Science and Higher Education [N302 157837]
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A potent plant-derived oral vaccine against Hepatitis B Virus (HBV) requires a durable and compact form for efficacious and convenient distribution and delivery. In the previous study we have devised a successful freeze-drying process of plant material containing the HBV small surface antigen (S-HBsAg) for the purpose of an oral vaccine against the virus, but product storage stability was limited to 4 degrees C. The aim of this study was to upgrade a freeze-dried product formula to facilitate successful long-term storage of S-HBsAg assembled into Virus-Like Particles (VLPs) at elevated temperatures. Series of additional excipients and storage conditions were tested. Atmosphere of nitrogen proved to preserve S-HBsAg VLPs most efficiently, with only minor degradation at the highest temperature of 37 degrees C. As a result, a semi product for the oral plant-derived vaccine against HBV with good storage capabilities was obtained. (C) 2015 The International Alliance for Biological Standardization. Published by Elsevier Ltd. All rights reserved.
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