Genentech, Inc.

Hoffmann-la Roche Inc.

F. Hoffmann-la Roche Ag

Michael Adler

Hanns-Christian Mahler

Oliver Boris Stauch

Ulla Grauschopf

Adeline Boillon

Joerg Luemkemann

Anke Dorn

Tim Dreckmann

Denis Luthringer

Karoline Bechtold-Peters

Alexander Meyer

Andreas Ernst

Karoline Bechthold-peters

A dosing system for transferring an aseptic fluid in dosages into a container, comprising a peristaltic pump configured such that the filling accuracy for fill volumes of the aseptic fluid<100 μL is ±3 μL.

Microdosing

A peristaltic dosing device for providing dosages of a fluid at a volume of less than one milliliter comprises: a flexible tube, a counter pressure element, a plurality of actors and a drive. The flexible tube is essentially straightly arranged along the counter pressure element thereby forming a longitudinal axis. The actors arranged parallel to each other along the longitudinal axis. They are moveable by the drive in relation to the flexible tube. The flexible tube is compressible between the actors and the counter pressure element by moving the actors. Each of the actors is independently and linearly moveable by the drive along an actuation axis essentially perpendicular to the longitudinal axis of the flexible tube from a home position in which the flexible tube is least compressed to an end position in which the flexible tube is compressed and sealed between the respective actor and the counter pressure element. The peristaltic dosing device according to the invention allows for exactly and repeatably providing dosages at comparably small volumes in a sterile environment.

Dosing a fluid at a volume of less than one milliliter

The present invention relates to a highly concentrated, stable pharmaceutical formulation of a pharmaceutically active anti-CD20 antibody, such as e.g. Rituximab, Ocrelizumab, or HuMab&#x3c;CD20&#x3e;, or a mixture of such antibody molecules for subcutaneous injection. In particular, the present invention relates to formulations comprising, in addition to a suitable amount of the anti-CD20 antibody, an effective amount of at least one hyaluronidase enzyme as a combined formulation or for use in form of a co-formulation. The said formulations comprise additionally at least one buffering agent, such as e.g. a histidine buffer, a stabilizer or a mixture of two or more stabilizers (e.g. a saccharide, such as e.g. &#x3b1;,&#x3b1;-trehalose dihydrate or sucrose, and optionally methionine as a second stabilizer), a nonionic surfactant and an effective amount of at least one hyaluronidase enzyme. Methods for preparing such formulations and their uses thereof are also provided.

Highly concentrated pharmaceutical formulations

The present invention relates to a highly concentrated, stable pharmaceutical formulation of a pharmaceutically active anti-HER2 antibody, such as e.g. Trastuzumab (HERCEPTIN&#x2122;), Pertuzumab or T-DM1, or a mixture of such antibody molecules for subcutaneous injection. In particular, the present invention relates to formulations comprising, in addition to a suitable amount of the anti-HER2 antibody, an effective amount of at least one hyaluronidase enzyme as a combined formulation or for use in form of a co-formulation. The formulations comprise additionally at least one buffering agent, such as e.g. a histidine buffer, a stabilizer or a mixture of two or more stabilizers (e.g. a saccharide, such as e.g. &#x3b1;,&#x3b1;-trehalose dihydrate or sucrose, and optionally methionine as a second stabilizer), a nonionic surfactant and an effective amount of at least one hyaluronidase enzyme. Methods for preparing such formulations and their uses thereof are also provided.

Subcutaneous anti-HER2 antibody formulations and uses thereof

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Riehen, Switzerland

Michael Adler