An investigation of excipients for a stable Orf viral vector formulation

• DOI: 10.1016/j.virusres.2023.199213
• Publication Date: 2023-09-06T16:06:02Z
• Authors: Friederike Eilts; Yasmina M.J. Harsy; Keven Lothert; Felix Pagallies; Ralf Amann; Michael W. Wolff
• Keywords: Infectivity; Human serum albumin; Bovine serum albumin

The Orf virus (ORFV) is a promising candidate for vector vaccines as well immunomodulatory and oncolytic therapies. However, few publications are available on its infectivity degradation or suitable additives prolonging viral stability. In this study, the non-supplemented ORFV itself showed very high stability at storage temperatures up to 28 °C, with linear titer loss of 0.10 log infectious particles per day 4 °C over period five weeks. To prolong inherent stability, thirty additives, i.e., detergents, sugars, proteins, salts, buffers amino acids, were tested their time- temperature-dependent influence infectivity. A stabilizing effect was identified addition all gelatine, bovine serum albumin, recombinant human albumin (rHSA), several mannitol, galactose, sucrose, trehalose, arginine proline, detergent Pluronic F68, salt Na2SO4. preservation especially pronounced proteins in liquid frozen formulations, sugars state, und formulations (37 °C). 1% rHSA without 5% sucrose evaluated stable formulation safety profile economic validity °C. At increased temperatures, supplementation 200 mM performed better than rHSA. summary, comprehensive data provides different options formulation, considering temperature, time, aspects, downstream processing integrity.