18991315. Subcutaneous anti-HER2 Antibody Formulations and Uses Thereof (GENENTECH, INC.)
Subcutaneous anti-HER2 Antibody Formulations and Uses Thereof
Organization Name
Inventor(s)
Hanns-Christian Mahler of Lörrach DE
Oliver Boris Stauch of Dornstadt DE
Subcutaneous anti-HER2 Antibody Formulations and Uses Thereof
This abstract first appeared for US patent application 18991315 titled 'Subcutaneous anti-HER2 Antibody Formulations and Uses Thereof
Original Abstract Submitted
The present invention relates to a highly concentrated, stable pharmaceutical formulation of a pharmaceutically active anti-HER2 antibody, such as e.g. Trastuzumab (HERCEPTIN™), 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. α,α-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.