The Green Cross Corporation

Yoshitomi Pharmaceutical Industries, Ltd.

Welfide Corporation

Yahiro Uemura

Satoshi Funakoshi

Tadakazu Suyama

Yutaka Hirao

Katuhiro Uriyu

Kazuo Takechi

Hirofumi Arimura

Motonori Hashimoto

Hiroshi Morise

Takao Ohmura

Tae Kitamura

Akinori Sumi

Masayuki Nishida

Wataru Ohtani

Takashi Goto

Kenji Tanaka

Kazumasa Yokoyama

Kaoru Kobayashi

Yoshio Arakawa

Masahiro Watanabe

Shinobu Kuwae

Tomoshi Ohya

Toyoo Ohda

Daisuke Satoh

Akimasa Ohmizu

Kenmi Miyano

Atuyuki Takanabe

Takashi Kobayashi

Tsuyoshi Takahashi

Eiji Kashiwagi

Kazuaki Nakura

Midori Nagatomo

Katashi Nakane

Yoshiaki Kano

Yoshiomi Okuno

Akio Yamane

Yoshitaka Sakanishi

Masao Ohyama

Shoju Kameyama

Masahiro Funayama

Kazumi Fukuyama

Ryutaro Yamana

Yoshiaki Kanou

Shouji Ideno

Tomokuni Taniguchi

Katsuhiro Uriyu

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 production method of a heterologous protein, comprising culturing a heterologous protein-producing host prepared by gene manipulation in a medium containing a fatty acid or a salt thereof, and a surfactant and harvesting the heterologous protein from the culture. The production amount of the heterologous protein produced by a heterologous protein-producing host can be increased. Moreover, since decomposition of the heterologous protein by an enzyme derived from the host can be inhibited, enabling large scale production of a heterologous protein.

Process for producing foreign proteins

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.

Immunoglobulin preparation and preparation process thereof

A method for producing antithrombin-III from an antithrombin-III-containing aqueous solution, comprising at least one of the following steps (a) and (b): (a) heating the antithrombin-III-containing aqueous solution in the presence of a stabilizing agent so that 85% or more of the activity of antithrombin-III before the heating is maintained after the heating, and that the ratio of an antithrombin-III monomer after the heating is maintained at 95% or more; and (b) treating the antithrombin-III-containing aqueous solution with a metal chelate resin and recovering a purified antithrombin-III.

Method for producing antithrombin-III, method for purifying it, and

A method of producing a virus-inactivated protein-containing composition from a protein-containing composition which may be contaminated with virus. The method according to the present invention permits production of pharmaceutically safer virus-inactivated protein preparations without spoiling the protein activity.

Production method for protein-containing composition

A method of fractionating plasma protein which comprises treating a plasma protein-containing material in the following sequence of steps, provided that steps (ii) through (v) may be performed in an optional order: (i) freeze-thaw treatment, (ii) treatment at 5 to 10% ethanol concentration, (iii) treatment with an anion exchanger, (iv) affinity chromatography with immobilized lysine, (v) affinity chromatography with immobilized heparin, (vi) treatment at 18 to 30% ethanol concentration, (vii) treatment at 35 to 45% ethanol concentration.

Method of fractionating plasma proteins

A method of producing immunoglobulin preparations for intravenous injection which starts with an immunoblobulin-containing fraction and comprises the treatment steps of:

Method of producing immunoglobulin preparations for intravenous injection

A method of purifying human serum albumin which comprises subjecting human serum albumin-containing solution to heat treatment of about 50.degree.-70.degree. C. for 1-5 hours in the presence of acetyltryptophan and/or an organic carboxylic acid with 6-12 carbon atoms or a salt thereof.

Method of purifying human serum albumin using organic carboxylic acids

A monoclonal antibody is described, having a specific reactivity with a cancer-associated antigen selected from pancreas cancer-associated antigen, intestinum crassum cancer-associated antigen and hepatoma-associated antigen and has the following characteristics:

Monoclonal antibody, process for preparing same, reagent for detecting

An intravenously injectable solution of chemically unmodified .gamma.-globulin having a complete molecular structure is disclosed, said solution containing sorbitol as a stabilizer and having a low electrical conductivity and a pH of about 5.5.+-.0.2. The injectable solution does not cause an increase of .gamma.-globulin polymer, a rise of anticomplement titer, or impairment of the activities of the .gamma.-globulin, either during preservation or upon administration to a living body.

Gamma-globulin injectable solutions containing sorbitol

A process for heat treating an aqueous solution containing chemically unmodified .gamma.-globulin, wherein said heat treating is carried out in the presence of sorbitol is disclosed. By the heat treatment, impurity viruses can be inactivated without causing impairment of activities of chemically unmodified .gamma.-globulin, increasing polymer contents or increasing an anticomplement titer.

Process for heat treating chemically unmodified gamma-globulin

Virus-contaminated immunoglobulin can be virus-inactivated by heating it in a substantially dry state at a temperature of 30.degree. to 100.degree. C. for a period of time sufficient for inactivating virus with maintaining original activity of the immunoglobulin. The addition of glycine, sodium chloride, sodium acetate, polyethylene glycol, albumin or mannitol enhances the effect and gives good solubility and good state to the solution of the virus-inactivated immunoglobulin.

Process for the virus-inactivation of immunoglobulin

A process for the purification of HBsAg is disclosed, which comprises adsorbing specifically on a carrier, in the presence of an inorganic salt in an amount of 5 to 25 W/V %, an HBsAg obtained by gene engineering.

Process for the purification of HBsAg

A dry .gamma.-globulin preparation capable of intravenous injection which is obtainable by polyethylene glycol fractionation of plasma is improved in its water-solubility and stability against increase of anticomplement activity and decrease of antibody titer by purifying the .gamma.-globulin fraction with respect to protein to render the residual polyethylene glycol substantially not detectable in its 5% W/V solution, adding 0.2 to 2 parts by weight of glucose based on 1 part of .gamma.-globulin, and lyophilizing its solution.

Gamma-globulin preparation for intravenous administration

Growing community of inventors

Osaka, Japan

Yahiro Uemura