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Publication Number
US-12150988-B2
Publication Date
2024-11-26
Expiration Date
Abstract
The present invention provides storage optimized aqueous compositions comprising a poxvirus suitable as poxvirus vaccine and pharmaceutical compositions, in particular liquid compositions or liquid frozen compositions, and methods of making them.
Core Innovation
The invention relates to improved storage-stable aqueous live poxvirus compositions, including non-lyophilized formulations, for long-term potency retention. The compositions are formulated for stability at refrigerator temperature, at -20°C, and at elevated temperature and humidity, and the live poxvirus is provided in an aqueous system designed to maintain infectivity and potency over extended periods.
The compositions include at least one disaccharide selected from trehalose and sucrose, sorbitol, gelatin hydrolysate, and albumin, together with a pharmaceutically acceptable buffer and at least one monovalent salt. The pH is between pH 7.3 and pH 8.1, and the formulation is described with selected buffer identities, such as Tris or phosphate, and monovalent salt identities, such as sodium chloride, optionally including MgCl2.
The document also describes formulations and stability assessment for recombinant poxvirus constructs that encode respiratory syncytial virus (RSV) antigens, including MVA-based recombinant viruses. Stability and potency retention results are reported using infectivity/potency criteria measured by FACS-based infectivity assays in cell-based evaluation, with comparative control formulations used to demonstrate improved retention.
Claims Coverage
The document includes two independent claims: one directed to an aqueous live poxvirus composition with defined excipient and pH parameters, and one directed to a method of making a stable aqueous live poxvirus composition by combining defined component solutions. Across the independent claims, the core inventive concept is captured through the specified stabilizer excipient system, the pharmaceutically acceptable buffer, at least one monovalent salt, and the pH range between pH 7.3 and pH 8.1.
Aqueous live poxvirus composition with defined stabilizer system and pH
An aqueous live poxvirus composition comprising at least one live poxvirus; a disaccharide selected from trehalose and sucrose at 4% (w/v) to 12% (w/v); sorbitol at 1% (w/v) to 3% (w/v); gelatin hydrolysate at 0.2% (w/v) to 4% (w/v); albumin at 0.2% (w/v) to 1.2% (w/v); a pharmaceutically acceptable buffer; and at least one monovalent salt; wherein the composition has a pH between pH 7.3 and pH 8.1.
Method of making a stable aqueous live poxvirus composition by combining defined solutions
A method of making a stable aqueous live poxvirus composition comprising providing a preparation comprising at least one live poxvirus in a pharmaceutically acceptable buffer; and combining said poxvirus preparation with a solution to create a combined composition comprising the specified disaccharide, sorbitol, gelatin hydrolysate, albumin, a pharmaceutically acceptable buffer, and at least one monovalent salt, with the buffer pH between pH 7.3 and pH 8.1.
Claim coverage centers on a defined aqueous stabilizer formulation for live poxvirus with the disaccharide/sorbitol/gelatin hydrolysate/albumin excipient system, combined with a pharmaceutically acceptable buffer and at least one monovalent salt, constrained to pH between pH 7.3 and pH 8.1. The second independent claim mirrors the same component system as a method of making the stable composition by combining a live poxvirus preparation with a solution containing the specified stabilizers, buffer, and monovalent salt.
Stated Advantages
Improved storage stability for aqueous live poxvirus compositions with long-term potency retention, including at refrigerator temperature and at -20°C.
Potency and infectivity retention under elevated temperature and humidity conditions for the defined aqueous formulations.
Documented Applications
Storage-stable aqueous live poxvirus formulations for long-term potency retention, including non-lyophilized compositions.
Formulations for recombinant poxvirus constructs encoding respiratory syncytial virus (RSV) antigens, including RSV F/G/N/M2-1.
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