Stable Aqueous Formulations of Adenovirus Vectors
AssigneeArecor Limited
InventorsJan JEZEK, Angela Buckler
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Abstract
The present invention is based on the surprising discovery that the inclusion of an anionic polymer in the adenovirus formulation enhances long-term stability of the vector composition. An aqueous formulation comprising an adenovirus vector and at least one anionic polymer is provided, together with methods of the preparation of a storage stable adenovirus aqueous formulation.
Claims40
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An aqueous formulation comprising an adenovirus vector and at least one anionic polymer is selected from the group consisting of:
- dextran sulfates, carboxymethyl cellulose, polyglutamate, polyaspartate, and salt forms thereof.
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An aqueous formulation comprising either:
- i) an adenovirus vector;
- a dextran sulfate with an average molecular weight between about 6500 Da and about 10000 Da;
- a dextran sulfate with an average molecular weight between about 500000 Da and about 3000000 Da;
- a combination of TRIS and benzoate ion;
- EDTA;
- sucrose;
- polysorbate 80;
- and polyvinyl alcohol, wherein the pH of the formulation is about 6;
- (ii) an adenovirus vector;
- a dextran sulfate with an average molecular weight between about 6500 Da and about 10000 Da;
- a dextran sulfate with an average molecular weight between about 500000 Da and about 3000000 Da;
- a combination of TRIS and benzoate ion;
- EDTA sucrose;
- and polysorbate 80, wherein the pH of the formulation is about 7;
- or (iii) an adenovirus vector;
- a dextran sulfate with an average molecular weight between about 6500 Da and about 10000 Da;
- a dextran sulfate with an average molecular weight between about 500000 Da and about 3000000 Da;
- a combination of TRIS and benzoate ion;
- sucrose;
- and polysorbate 80, wherein the pH of the formulation is about 6.5.
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A method for the preparation of a storage stable adenovirus aqueous liquid formulation, comprising:
- forming a mixture of an adenovirus vector and at least one anionic polymer.
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Dependencies are inferred from the claim text.