Room temperature storable immunoglobulin preparation for intravenous injection
AssigneeWelfide Corporation
InventorsYutaka Hirao, Motonori Hashimoto, Tae Kitamura, Yahiro Uemura
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Abstract
A method for producing an immunoglobulin preparation for intravenous injection, which comprises the steps of: fractionating an immunoglobulin-containing solution with 4 to 10 w/v% of polyethylene glycol having a molecular weight of from 1,000 to 10,000, at a pH value of from 4.5 to 6.5, an ionic strength of from 0.0001 to 0.1 M and a temperature of from 0 to 4° C. to recover a supernatant fraction; and concentrating the supernatant fraction at a pH of from 3.5 to 5.0.
Claims5
An immunoglobulin preparation for intravenous injection which is stable in the solution state for at least one year at room temperature, and contains
- at most 5 micrograms (μg) per ml of HSA (human serum albumin),
- at most 16 picograms (pg) per ml of MCP-1 (human monocyte chemotactic protein-1),
- at most 3 micrograms (μg) per ml of C3a (activated human complement-3) and
- at most 1 mg per dl polyethylene glycol, and
- which is an immunoglobulin liquid preparation for intravenous injection which contains
- a chemically unmodified complete molecule immunoglobulin and
- has a pH value of from 5 to 6 and
- an electric conductivity of 1 mmho or less (calculated at 8° C.),
- wherein the preparation can be stored at room temperature for at least one year after its production and
- can maintain its anticomplement titer at 20 units or less, and the dimer content of the immunoglobulin at 7% or less, constantly during the storage period, and which contains sorbitol as a stabilizer.
An immunoglobulin preparation for intravenous injection which is stable in the solution state for at least one year at room temperature, and contains
- at most 5 micrograms (μg) per ml of HSA (human serum albumin),
- at most 16 picograms (pg) per ml of MCP-1 (human monocyte chemotactic protein-1),
- at most 3 micrograms (μg) per ml of C3a (activated human complement-3) and
- at most 1 mg per dl polyethylene glycol, and
- which is an immunoglobulin liquid preparation for intravenous injection which contains
- a chemically unmodified complete molecule immunoglobulin and
- has a pH value of from 5 to 6 and
- an electric conductivity of 1 mmho or less (calculated at 8° C.),
- wherein the preparation can be stored at room temperature for at least one year after its production and
- can maintain its anticomplement titer at 20 units or less, and the dimer content of the immunoglobulin at 7% or less, constantly during the storage period, and
- which is prepared by carrying out a virus inactivation treatment wherein the virus inactivation is a wet heat treatment.
Dependencies are inferred from the claim text.