Virus-containing formulation and use thereof
Inventors
Assignees
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Publication Number
US-10111947-B2
Publication Date
2018-10-30
Expiration Date
Abstract
The present invention relates to formulation comprising (i) at least one virus-based material, (ii) at least one polymer selected in the group of polyvinylpyrrolidone and derivatives thereof, (iii) at least one sugar, (iv) at least two different amino acids, (v) at least two pharmaceutical acceptable salts, wherein at least one of said salts is a phosphate salt and, optionally (vi) a pharmaceutical acceptable buffer. Such a formulation is particularly suitable for freeze-drying. The present invention also relates to the corresponding dry product, as well as its preparation process. The present invention also relates to a reconstituted material comprising said dry product, which can be administered to a patient in need thereof. Such formulation and reconstituted material are useful as vaccines, preferably for the treatment and/or the prevention of cancers, infectious diseases and/or autoimmune disorders.
Core Innovation
The disclosure describes virus-containing freeze-dried vaccine formulations that combine an attenuated or recombinant poxvirus-based material with a polymer selected from polyvinylpyrrolidone and derivatives thereof, a disaccharide, arginine and glutamate, and defined pharmaceutical salts in which at least one is a phosphate salt. Optionally, the formulations further include a pharmaceutical acceptable buffer with a pH comprised between about 7 and about 8.5.
The phosphate salt component is identified as participating in stabilizing the virus during freeze-drying and storage. The disclosure specifies dry product attributes including residual moisture content and discusses freeze-drying conditions that include relatively warm secondary drying.
The formulation components are positioned as a combined protective system for maintaining viral titer during processing and subsequent storage. The document further describes stability and viral titer retention metrics over storage, including storage at 5°C and accelerated conditions at 45°C, and it reports performance for the reconstituted material.
Claims Coverage
The independent claim covers a freeze-dried formulation with six inventive features, with multiple concentration ranges and an optional buffer within a specific pH interval. The main inventive features are further refined in dependent claims by specifying particular poxvirus-based materials, salt identities, quantitative constraints, and selection criteria.
Attenuated or recombinant poxvirus-based material in a freeze-dried formulation
A freeze-dried formulation comprising at least one attenuated or recombinant poxvirus-based material.
Polyvinylpyrrolidone polymer at defined concentration ranges
A freeze-dried formulation comprising between 5 g/L and 80 g/L of at least one polymer selected from the group consisting of polyvinylpyrrolidone and derivatives thereof.
Disaccharide at defined concentration ranges
A freeze-dried formulation comprising between 20 g/L and 80 g/L of at least one disaccharide.
Arginine and glutamate as formulation components
A freeze-dried formulation comprising arginine and glutamate.
Phosphate salt and monovalent salt at defined concentration ranges
A freeze-dried formulation comprising between 0.1 g/L and 5 g/L of at least one pharmaceutical acceptable phosphate salt and between 1 g/L and 5 g/L of at least one pharmaceutical acceptable monovalent salt.
Optional buffer with pH between about 7 and about 8.5
Optionally comprising a pharmaceutical acceptable buffer wherein the pH of the formulation is comprised between about 7 and about 8.5.
Overall, the claim coverage centers on a freeze-dried virus-containing vaccine formulation defined by a poxvirus-based material plus a PVP-type polymer, a disaccharide, arginine and glutamate, and specified phosphate and monovalent salt components, with optional buffer control of pH between about 7 and about 8.5. Dependent claims narrow the poxvirus material to specific named poxvirus types/engineered constructs and refine quantitative constraints such as polymer molecular weight and poxvirus titer.
Stated Advantages
Stabilizing the virus during freeze-drying and storage, thereby limiting viral titer loss during drying and storage.
Documented Applications
Therapeutic or prophylactic use for cancer.
Therapeutic or prophylactic use for infectious diseases.
Therapeutic or prophylactic use for autoimmune disorders.
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