Stabilisation of viral particles
Inventors
Drew, Jeffrey • Woodward, David • BAINBRIDGE, JOHN • Corteyn, Amanda
Assignees
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Publication Number
US-10206960-B2
Publication Date
2019-02-19
Expiration Date
Abstract
A method for preserving viral particles comprising: (a) providing an aqueous solution of (i) viral particles, (ii) optionally one or more sugars, and (iii) a compound of formula (I) or a physiologically acceptable salt or ester thereof and/or a compound of formula (II) or a physiologically acceptable salt or ester thereof; and (b) drying the solution to form a composition incorporating said viral particles.
Core Innovation
The invention relates to preserving live viral particles during freeze-drying. An aqueous solution is prepared that optionally is buffered and comprises live viral particles and excipients, the excipients comprising one or more sugars at a total sugar concentration of 0.1 M to 3M, N,N-dimethylglycine or a physiologically acceptable salt or ester thereof at 0.1 to 1.5M, and methylsulfonylmethane at 0.1 to 1.5M as the sole excipients in the aqueous solution.
The solution is freeze-dried to form a composition incorporating the live viral particles. The approach is defined for live viral particles selected from a broad set of virus families, including Adenoviridae, Orthomyxoviridae, Paramyxoviridae, Parvoviridae, Picornaviridae, Poxviridae, Calciviridae, Coronaviridae, Filoviridae, Flaviviridae, Hepadnaviridae, Herpesviridae, Papillomaviridae, Reoviridae, Retroviridae, and Togaviridae.
A related aspect is preparing a vaccine that incorporates live viral particles preserved during freeze-drying. The method prepares an aqueous solution comprising the live viral particles and sugars together with N,N-dimethylglycine and methylsulfonylmethane at defined concentrations, optionally includes buffering, and optionally adds an adjuvant, buffer, antibiotic and/or additive before freeze-drying to form a solid composition incorporating the live viral particles.
Claims Coverage
The provided excerpt includes four independent claims. Across these claims, the inventive features are centered on a constrained aqueous excipient system comprising one or more sugars, N,N-dimethylglycine, and methylsulfonylmethane at specified concentration ranges, followed by freeze-drying to obtain a composition or solid composition incorporating live viral particles, with optional buffer and optional formulation additives for vaccine preparation.
Preservation during freeze-drying with sole sugar excipients plus N,N-dimethylglycine and methylsulfonylmethane
Preparing an aqueous solution comprising live viral particles and, as the sole excipients, one or more sugars at a total sugar concentration of 0.1 M to 3M, 0.1 to 1.5M of N,N-dimethylglycine or a physiologically acceptable salt or ester thereof, and 0.1 to 1.5M of methylsulfonylmethane; and freeze-drying the solution to form a composition incorporating the live viral particles.
Vaccine preparation incorporating freeze-dried preserved live viral particles with constrained excipient system
Preparing an aqueous solution comprising live viral particles and, as the sole excipients, one or more sugars at a total sugar concentration of 0.1 M to 3M, 0.1 to 1.5M of N,N-dimethylglycine or a physiologically acceptable salt or ester thereof, and 0.1 to 1.5M of methylsulfonylmethane; optionally adding an adjuvant, buffer, antibiotic and/or additive; and freeze-drying to form a solid composition incorporating the live viral particles.
Preservation with defined aqueous solution composition including optional buffers
Preparing an aqueous solution which consists of live viral particles selected from the specified virus families, one or more sugars at a total sugar concentration of 0.1M to 3M, 0.1 to 1.5M of N,N-dimethylglycine or a physiologically acceptable salt or ester thereof, 0.1 to 1.5M of methylsulfonylmethane, and optionally one or more buffers; and freeze-drying the solution to form a composition incorporating the live viral particles.
Vaccine preparation with specified live virus family list and constrained excipients
Preparing an aqueous solution, which is optionally buffered, and consists of live viral particles selected from the specified virus families, one or more sugars at a total sugar concentration of 0.1M to 3M, 0.1 to 1.5M of N,N-dimethylglycine or a physiologically acceptable salt or ester thereof, and 0.1 to 1.5M of methylsulfonylmethane; optionally adding an adjuvant, buffer, antibiotic and/or additive; and freeze-drying the solution to form a composition or solid composition incorporating the live viral particles.
Across the independent claims, the coverage concentrates on forming an aqueous solution with live viral particles and a defined stabilizing excipient set, followed by freeze-drying to yield a composition or solid composition incorporating the live viral particles.
Stated Advantages
Preserved virus structure and/or function.
Improved thermal resistance and shelf life.
Reduced need for cold chain.
Ability to store the aqueous preservation mixture prior to drying.
Documented Applications
Preserving live viral particles during freeze-drying.
Preparing a vaccine incorporating live viral particles that are preserved during freeze-drying.
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