Stable and Filterable Enveloped Virus Formulations
AssigneeWellstat Biologics Corporation
InventorsTzer-Fen Chen, Jouhn-Wern Jang, Jeffrey A. Miller
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Abstract
Envelope viruses (e.g. Newcastle disease virus (NDV)) are formulated for storage at moderately cold temperatures (e.g. −20 C). The formulation is an aqueous solution containing the enveloped virus at a concentration of from 106 PFU/mL to 1012 PFU/mL; and a non-reducing saccharide (e.g. sucrose). When the non-reducing saccharide is a disaccharide it is present in the solution at a concentration of from 5% (w/v) to 50% (w/v), and when it is a monosaccharide it is present in the solution at a concentration of from 2.5% (w/v) to 25% (w/v). The solution has an osmotic pressure of about 250 mOs or higher, and has a pH of from 5 to 10.
Claims27
A method for stabilizing an enveloped virus for moderately cold temperature storage, comprising preparing an aqueous solution consisting essentially of:
- the enveloped virus at a concentration of from 106 PFU/mL to 1012 PFU/mL;
- and a non-reducing saccharide,
- wherein the saccharide is a disaccharide and is present in the solution at a concentration of from 5% (w/v) to 50% (w/v) or a monosaccharide and is present in the solution at a concentration of from 2.5% (w/v) to 25% (w/v);
- wherein the solution
- has an osmotic pressure of about 250 mOs or higher;
- and has a pH of from 5 to 10.
A method for stabilizing an enveloped virus for moderately cold temperature storage comprising preparing an aqueous solution comprising:
- an enveloped virus at a concentration of from 106 PFU/mL to 1012 PFU/mL;
- and a non-reducing saccharide,
- wherein the saccharide is a disaccharide and is present in the solution at a concentration of from 5% (w/v) to 50% (w/v) or a monosaccharide and is present in the solution at a concentration of from 2.5% (w/v) to 25% (w/v);
- wherein the solution
- has an osmotic pressure of about 250 mOs or higher;
- has a pH of from 5 to 10;
- and contains
- substantially no reducing agents or antioxidants,
- and less than:
- 0.1% (w/v) Sodium chloride;
- 1% (w/v) Dextran;
- 0.5% (w/v) Mannitol;
- 0.1% (w/v) Sorbitol;
- 0.01% (w/v) Tween;
- 0.01% (w/v) Glutamate;
- 0.5% (w/v) polyethylene glycol;
- 0.1 mM Calcium chloride;
- 0.5% (w/v) Phosphatidyl choline;
- 0.05% (w/v) Glycine;
- and
- 0.01% (w/v) phosphate.
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Dependencies are inferred from the claim text.