Takeda Pharmaceutical Company Limited

Amgen Research (Munich) Gmbh

Takeda Gmbh

Amgen Research Gmbh

Gerhard Becker

Markus Rast

Henning Gieseler

Wolfgang Ise

Peter Skufca

Pernille Dybendal Pedersen

Wolfram Steinhilber

Jürgen Volz

Thomas Urbig

Thomas Boehm

Christian De Muynck

Jurgen Volz

The present invention provides a method for preparation of a lyophilized formulation of an anti-CD 20 antibody as well as to a lyophilized formulation of an anti-CD 20 antibody, comprising an anti-CD 20 antibody and having a residual moisture content in the range of 1% to 10%. The present invention also relates to the reconstituted formulation obtained by the method described herein, the use of said antibody formulation as a medicament, the use of the lyophilized formulation for the preparation of a medicament and a method of treating a patient.

Formulation of an antibody and use thereof

The present invention relates to aqueous formulations comprising at least 20 mg/ml of a compound neutralizing GM-CSF, a lyoprotectant and an amino acid and/or a buffer. The ingredients of the formulation preferably provide stability to the compound neutralizing GM-CSF in view of lyophilization, storage and reconstruction. In a preferred aspect, the formulation, e.g. after reconstruction, is for use in therapy, preferably for use in the treatment of inflammatory and autoimmune disorders, preferably including allergic and psoriatic disorders, as well as arthritic and asthmatic disorders. Furthermore, a kit comprising the formulation of the invention is provided.

Lyophilized formulation comprising GM-CSF neutralizing compound

Growing community of inventors

Allensbach, Germany

Gerhard Becker