Amgen Inc.

Ajinomoto Co., Ltd.

Coherus Biosciences, Inc.

Chugai Seiyaku Kabushiki Kaisha

Ipsen Pharma S.a.s.

Tsutomu Arakawa

Daisuke Ejima

Douglas Farrar

Yoshiko Kita

Ryosuke Yumioka

Hajime Koyama

Francis Hall Martin

Joel Richard

Tadao Yamazaki

Masaya Kakuta

Dimitry Michael Danilenko

Akira Hayasaka

Haruna Sato

Joël Richard

Susan Park

Yoshiki Hayashi

Nobuyuki Itoh

Enona Gopinath

Yoshiko A Kita

A mixed mode chromatography method for separating correctly folded from incorrectly folded conformations of a given protein is provided. The method is highly effective in separating correctly folded etanercept from incorrectly folded etanercept and aggregates in commercially attractive yields capable of affording etanercept preparations having very high purity in terms of correctly folded etanercept versus incorrectly folded etanercept. The invention is further directed to protein preparations and formulations comprising correctly folded proteins obtained using the present methods, and methods of treatment using the high purity preparations obtained from the mixed mode method.

Correctly folded etanercept in high purity and excellent yield

The invention provides a virus-inactivating composition with pH of 3.8 to 5.5, containing (A) 0.02 to 0.3 M arginine and (B) a component such as 0.01 to 10 mM flavonoid, polyphenol, or ascorbic acid derivative, 0.005 to 5 mass % of an arginine derivative, and 0.1 to 2.5 mass % of an extract solution of natural product.

Virus-inactivating composition containing low-molecular weight compound and arginine

The present invention provides a method for conveniently producing a protein formulation in which viruses are inactivated, without impairing the quality of the obtained protein formulation, characterized by including the step of exposing the protein formulation contaminated with the viruses to a 0.1-2M aqueous solution of arginine, an arginine derivative, or a mixture thereof, the aqueous solution being adjusted to pH 3.5 to 5. The present invention also provides a virus inactivation method characterized by including the step of contacting a virus-containing object with a 0.1-2M aqueous solution of arginine, an arginine derivative, or a mixture thereof, the aqueous solution being adjusted to pH 3.5 to 5.

Method for inactivating viruses with slightly acidic arginine

The present invention provides stabilized preparations containing an antibody in a glycine buffer and/or a histidine buffer and also provides processes for preparing a protein-containing stabilized preparation, comprising adjusting the pH with a basic amino acid or a basic amino acid derivative or a salt thereof.

Stabilized anti-interleukin-6 antibody-containing preparations

The present invention provides a method of purifying an antibody by protein A affinity chromatography. More specifically, the present invention provides a technique relating to an elution buffer solution which provides a good antibody recovery rate without denaturation.

Purification method which prevents denaturation of an antibody

Anti-Her2 antibodies which induce apoptosis in Her2 expressing cells are disclosed. The antibodies are used to 'tag' Her2 overexpressing tumors for elimination by the host immune system. Also disclosed are hybridoma cell lines producing the antibodies, methods for treating cancer using the antibodies, and pharmaceutical compositions.

Antibody-induced apoptosis

A method to more quantitatively recover a peak of a protein and associated aggregates, hydrophobic proteins, or hydrophobic peptides which are typically difficult to recover and detect as a peak, using a commercially available gel filtration chromatography column and a mobile phase is described. More specifically, a compound, such as arginine, which may be added to the mobile phase, thereby eliminating the unnecessary interaction that occurs between the proteins, peptides, or aggregates and the column stationary phase, is described.

Method for improving recovery yield in protein purification with gel filtration chromatography

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Thousand Oaks, CA, United States of America

Tsutomu Arakawa