Chugai Seiyaku Kabushiki Kaisha

Hoffmann-la Roche Inc.

F. Hoffmann-la Roche Ag

Daisuke Kameoka

Toshiyuki Morichika

Oliver Boris Stauch

Yoshimi Imaeda

Terutoshi Maeda

Hitoshi Sasaki

Toru Yoshizawa

Megumi Numata

Hiroko Murata

So Yamaguchi

Naoka Hironiwa

Masaya Yasutake

Tomoyuki Igawa

Chifumi Imai

Atsushi Watanabe

Akira Hayasaka

Masakazu Fukuda

In one non-limiting embodiment, the present disclosure relates to lyophilized formulations containing an IL-31 antagonist (for example, an anti-IL-31RA antibody) as an active ingredient, the lyophilized formulations further containing arginine and/or a salt thereof and sucrose and/or trehalose. In another non-limiting embodiment, the present disclosure relates to solution formulations containing an IL-31 antagonist as an active ingredient, the solution formulations further containing arginine and/or a salt thereof. In other non-limiting embodiments, the present disclosure relates to methods for stabilizing an antibody (for example, an anti-IL-31RA antibody) in an antibody-containing formulation, methods for suppressing antibody aggregation (aggregate formation) in an antibody-containing formulation, and methods for reducing components with charge heterogeneity in an antibody-containing formulation, the methods being characterized in that the formulation is prepared to contain arginine and/or a salt thereof, and/or sucrose and/or trehalose.

Anti-IL-31RA antibody-containing formulations

The problem to be solved is to provide a humanized anti-IL-6 receptor antibody AMA-containing formulation which is suitable for subcutaneous administration, wherein dimerization or deamidation is prevented during long-term storage. The present application is directed to a stable antibody-containing liquid formulation characterized by containing arginine and histidine buffer. A method of inhibiting deamidation or dimerization of such an antibody in a concentrated liquid formulation includes histidine buffer in the liquid formulation.

High concentration antibody-containing liquid formulation

Methods of administering anti-IL31A antibody-containing formulations

The problem to be solved is to provide a humanized anti-IL-6 receptor antibody MRA-containing formulation which is suitable for subcutaneous administration, wherein dimerization or deamidation is prevented during long-term storage. The present application is directed to a stable antibody-containing liquid formulation characterized by containing arginine and histidine buffer. A method of inhibiting deamidation or dimerization of such an antibody in a concentrated liquid formulation includes histidine buffer in the liquid formulation.

Anti-IL31RA antibody-containing formulations

The problem to be solved is to provide an antibody-containing formulation which is stable and suited for subcutaneous administration, wherein dimerization and deamidation is prevented during long-term storage. The present application is directed to a stable antibody-containing liquid formulation characterized by containing arginine and methionine.

Addition of argininamide or valinamide to a highly concentrated antibody solution was found to lead to remarkable stabilization, in particular, stabilization against photostress.

Stable protein-containing preparation containing argininamide or analogous compound thereof

The present invention relates to antibody-containing lyophilized formulations free from reducing sugars, non-reducing sugars, sugar alcohols or polysaccharides as excipients and including one or more amino acid selected from the group consisting of arginine, histidine, lysine, serine, proline, glycine, alanine and threonine or a salt thereof.

Stabilized antibody-containing formulations

Stable Protein-containing preparation containing argininamide or analogous compound thereof

An objective of the present invention is to provide methods for stabilizing proteins and methods for suppressing protein aggregation, which comprise the step of adding meglumine to the proteins. Another objective of the present invention is to provide agents for suppressing protein aggregation, which comprise meglumine. Still another objective of the present invention is to provide pharmaceutical compositions comprising antibody molecules stabilized by meglumine, methods for producing the pharmaceutical compositions, and kits comprising the pharmaceutical compositions. To achieve the objectives described above, the present inventors assessed the antibody-stabilizing effect of meglumine, an amino sugar. As a result, the inventors discovered that meglumine was useful as a stabilizer for antibody molecules and also as an excipient for freeze-dried preparations.

Stabilizer for protein preparation comprising meglumine and use thereof

Growing community of inventors

Tokyo, Japan

Daisuke Kameoka