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    Subcutaneous anti-HER2 Antibody Formulations and Uses Thereof
    1.
    发明申请
    Subcutaneous anti-HER2 Antibody Formulations and Uses Thereof 有权

    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.

    Subcutaneous anti-HER2 Antibody Formulations and Uses Thereof
    3.
    发明申请
    Subcutaneous anti-HER2 Antibody Formulations and Uses Thereof 有权

    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.

    PREFILLED SYRINGE AND METHOD OF PREPARING A PREFILLED SYRINGE
    4.
    发明公开
    PREFILLED SYRINGE AND METHOD OF PREPARING A PREFILLED SYRINGE 审中-公开

    公开(公告)号：US20230310681A1

    公开(公告)日：2023-10-05

    申请号：US18330083

    申请日：2023-06-06

    Applicant: F. HOFFMANN-LA ROCHE AG ,  GENENTECH, INC.

    Inventor： Markus HEMMINGER ,  Ulla GRAUSCHOPF ,  Frank BAMBERG ,  Mayumi BOWEN ,  Robert MÜLLER ,  Flora FELSOVALYI ,  Denny CHRISTENSEN

    IPC: A61L2/20 ,  A61M5/00 ,  A61M5/31 ,  A61M5/315 ,  A61M5/32 ,  B65B3/00 ,  B65B7/28 ,  B65B55/10

    CPC classification number: A61L2/206 ,  A61M5/001 ,  A61M5/002 ,  A61M5/3129 ,  A61M5/315 ,  A61M5/3202 ,  B65B3/003 ,  B65B7/2821 ,  B65B55/10 ,  A61L2202/23 ,  A61M2005/3114 ,  A61M2205/0238 ,  A61M2207/10 ,  A61M2207/00 ,  A61L2202/24 ,  A61M5/31513 ,  A61M2005/3104 ,  B65B55/02

    Abstract: A method of preparing a prefilled syringe (1), comprises (i) obtaining a syringe barrel (11) having an open end (111) and a tip (112) with an orifice (113) essentially opposite to the open end (111), and a needle adaptor cap (12) assembled on the tip (112) of the syringe barrel, wherein the needle adaptor cap (12) has a rubber element (121) tightly sealing the orifice (113) of the tip (112) of the syringe barrel (11) and the syringe barrel (11) together with the needle adaptor cap (12) assembled on the tip (112) of the syringe barrel (11) is sterilized by a first sterilizing comprising a main step of exposing the syringe barrel (11) together with the needle adaptor cap (12) assembled on the tip (112) of the syringe barrel (11) to ethylene oxide for about 5 hours to about 60 hours at a relative humidity of about 40% to about 100% and at a temperature of about 30° C. to about 60° C.; (ii) filling a drug substance (14) through the open end (111) of the syringe barrel (11) into an interior of the syringe barrel; (iii) sealing the interior of the syringe barrel (11) by advancing a rubber stopper (13) through the open end (111) of the syringe barrel (11); (iv) packaging the syringe barrel (11) together with the rubber stopper (13) sealing the interior of the syringe barrel (11) and the needle adaptor cap (12) assembled on the tip (112) of the syringe barrel (11); and (v) second external surface sterilizing the packaged syringe barrel (11) together with the rubber stopper (13) sealing the interior of the syringe barrel (11) and the needle adaptor cap (12) assembled on the tip (112) of the syringe barrel (11). The rubber element (121) of the needle adaptor cap (12) and the rubber stopper (13) are made of a rubber material having a comparably low oxygen transmission rate such as, at 1 atmosphere, of not more than 64 cubic centimeter per square meter and day. The second external surface sterilizing comprises a main step of exposing the packaged syringe barrel (11) together with the rubber stopper (13) sealing the interior of the syringe barrel (11) and the needle adaptor cap (12) assembled on the tip (112) of the syringe barrel (11) to ethylene oxide for about 3 hours to about 30 hours at a relative humidity of about 40% to about 100% and at a temperature of about 25° C. to about 45° C. At least one of the duration, the relative humidity and the temperature of the second external surface sterilizing is essentially lower than the respective duration, relative humidity or temperature of the first sterilization.

    PREFILLED SYRINGE AND METHOD OF PREPARING A PREFILLED SYRINGE
    6.
    发明申请
    PREFILLED SYRINGE AND METHOD OF PREPARING A PREFILLED SYRINGE 审中-公开

    公开(公告)号：US20200282130A1

    公开(公告)日：2020-09-10

    申请号：US16651444

    申请日：2018-09-28

    Applicant: F. HOFFMANN-LA ROCHE AG ,  GENENTECH, INC.

    Inventor： Markus HEMMINGER ,  Ulla GRAUSCHOPF ,  Frank BAMBERG ,  Mayumi BOWEN ,  Robert MÜLLER ,  Flora FELSOVALYI ,  Denny CHRISTENSEN

    IPC: A61M5/00 ,  A61M5/31 ,  A61M5/315 ,  A61M5/32 ,  A61L2/20

    Abstract: A method of preparing a prefilled syringe is disclosed that includes obtaining a syringe barrel and a needle adaptor cap assembled on the tip of the syringe barrel, wherein the needle adaptor cap has a rubber element tightly sealing the orifice of the tip of the syringe barrel and the syringe barrel together with the needle adaptor cap assembled on the tip of the syringe barrel is sterilized by a first sterilizing. Filling a drug substance into an interior of the syringe barrel and sealing the interior of the syringe barrel. Packaging the syringe barrel with a rubber stopper sealing the interior thereof and the needle adaptor cap assembled on the tip of the syringe barrel. Providing a second external surface sterilizing of the packaged syringe barrel with the rubber stopper sealing the interior thereof and the needle adaptor cap assembled on the tip of the syringe barrel.

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