Welfide Corporation

Yoshitomi Pharmaceutical Industries, Ltd.

Tae Kitamura

Yahiro Uemura

Motonori Hashimoto

Yutaka Hirao

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&deg; C. to recover a supernatant fraction; and concentrating the supernatant fraction at a pH of from 3.5 to 5.0.

Room temperature storable immunoglobulin preparation for intravenous injection

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.degree. C. to recover a supernatant fraction; and concentrating the supernatant fraction at a pH of from 3.5 to 5.0.

Room temperature storable immunoglobulin preparation for intravenous

An immunoglobulin preparation comprising an immunoglobulin, wherein the preparation contains, as a contaminant, serum albumin in an amount not greater than 10 .mu.g per 50 mg of immunoglobulin; and/or wherein the preparation is free of fine particles which can serve as a nucleus of insoluble foreign matter, and processes for preparing the immunoglobulin preparation are described.

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Osaka, Japan

Tae Kitamura