title: Stability of S-HBsAg in long-term stored lyophilised plant tissue.
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.
authors.affiliation: Institute of Plant Genetics, Polish Academy of Sciences, Strzeszyńska 34, 60-479 Poznań, Poland.
authors.forename: Marcin
authors.initials: M
authors.lastname: Czyż
authors.affiliation: Poznań University of Life Sciences, Wojska Polskiego 28, 60-995 Poznań, Poland.
authors.forename: Radosław
authors.initials: R
authors.lastname: Dembczyński
authors.affiliation: Poznań University of Life Sciences, Wojska Polskiego 28, 60-995 Poznań, Poland.
authors.forename: Roman
authors.initials: R
authors.lastname: Marecik
authors.affiliation: Institute of Plant Genetics, Polish Academy of Sciences, Strzeszyńska 34, 60-479 Poznań, Poland. Electronic address: tpni@igr.poznan.pl.
authors.forename: Tomasz
authors.initials: T
authors.lastname: Pniewski
mesh_terms: D005612:Freeze Drying; D006514:Hepatitis B Surface Antigens / Q000737:chemistry*; D017325:Hepatitis B Vaccines / Q000737:chemistry*; D006515:Hepatitis B virus; D018515:Plant Leaves / Q000737:chemistry*; D055550:Protein Stability; D011994:Recombinant Proteins / Q000737:chemistry
chemical_list: D006514:Hepatitis B Surface Antigens; D017325:Hepatitis B Vaccines; D011994:Recombinant Proteins
keywords: Biopharmaceuticals; Freeze-drying; HBV; Long-term storage; Plant-derived oral vaccine; S-HBsAg