公开(公告)号：US20250121059A1

公开(公告)日：2025-04-17

申请号：US18991315

申请日：2024-12-20

Applicant: Genentech, Inc.

Inventor： Michael ADLER ,  Ulla GRAUSCHOPF ,  Hanns-Christian MAHLER ,  Oliver Boris STAUCH

IPC: A61K39/395 ,  A61K9/00 ,  A61K9/08 ,  A61K9/19 ,  A61K38/47 ,  A61K45/06 ,  A61K47/18 ,  A61K47/20 ,  A61K47/26 ,  A61K47/42 ,  C07K16/32

Abstract: 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.

公开(公告)号：US20240207400A1

公开(公告)日：2024-06-27

申请号：US18459857

申请日：2023-09-01

Applicant: Genentech, Inc.

Inventor： Michael ADLER ,  Ulla GRAUSCHOPF ,  Hanns-Christian MAHLER ,  Oliver Boris STAUCH

IPC: A61K39/395 ,  A61K9/00 ,  A61K9/08 ,  A61K9/19 ,  A61K38/47 ,  A61K45/06 ,  A61K47/18 ,  A61K47/20 ,  A61K47/26 ,  A61K47/42 ,  C07K16/32

CPC classification number: A61K39/39558 ,  A61K9/0019 ,  A61K9/08 ,  A61K9/19 ,  A61K38/47 ,  A61K39/39591 ,  A61K45/06 ,  A61K47/18 ,  A61K47/183 ,  A61K47/20 ,  A61K47/26 ,  A61K47/42 ,  C07K16/32 ,  C12Y302/01035

Abstract: 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.

公开(公告)号：US20250090660A1

公开(公告)日：2025-03-20

申请号：US18635280

申请日：2024-04-15

Applicant: Genentech, Inc.

Inventor： Michael ADLER ,  Ulla GRAUSCHOPF ,  Hanns-Christian MAHLER ,  Oliver Boris STAUCH

IPC: A61K39/395 ,  A61K9/00 ,  A61K9/08 ,  A61K9/19 ,  A61K38/47 ,  A61K45/06 ,  A61K47/18 ,  A61K47/20 ,  A61K47/26 ,  A61K47/42 ,  C07K16/32

Abstract: 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.