Stability of S-HBsAg in long-term stored lyophilised plant tissue. Issue 2 (March 2016)

• Record Type: Journal Article
• Authors: Czyż, Marcin; Dembczyński, Radosław; Marecik, Roman; Pniewski, Tomasz
• Is Part Of: Biologicals. Volume 44:Issue 2(2016:Mar.)
• Page Start: 69
• Page End: 72
• Publication Date: 2016-03
• Subjects: Biopharmaceuticals -- Freeze-drying -- Long-term storage -- HBV -- Plant-derived oral vaccine -- S-HBsAg; Biological products -- Standards -- Periodicals; Biological Products -- Periodicals; Biological Products -- standards -- Periodicals; Produits biologiques -- Normes -- Périodiques; Biological products -- Standards; Periodicals; 615.37
• DOI: 10.1016/j.biologicals.2015.12.001
• Languages: English
• ISSNs: 1045-1056

Abstract

Abstract: 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 °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 °C. As a result, a semi-product for the oral plant-derived vaccine against HBV with good storage capabilities was obtained.