公开(公告)号：US20210292435A1

公开(公告)日：2021-09-23

申请号：US17083163

申请日：2020-10-28

Applicant: Genentech, Inc.

Inventor： Nicholas J. ARMSTRONG ,  Mayumi N. BOWEN ,  Yuh-Fun MAA

IPC: C07K16/40 ,  A61K9/16 ,  A61K39/395 ,  A61K9/10 ,  A61K9/00 ,  C07K16/22 ,  C07K16/28 ,  C07K16/32

Abstract: The present application discloses high-concentration monoclonal antibody formulations suitable for subcutaneous administration, e.g. via a pre-filled syringe. In particular, it discloses a formulation comprising a spray dried monoclonal antibody at a concentration of about 200 mg/mL or more suspended in a non-aqueous suspension vehicle where the viscosity of the suspension vehicle is less than about 20 centipoise. Also disclosed are: a subcutaneous administration device with the formulation therein, a method of making the formulation, a method of making an article of manufacture comprising the suspension formulation, use of the formulation in the preparation of a medicament, and a method of treating a patient with the formulation.

公开(公告)号：US20240425615A1

公开(公告)日：2024-12-26

申请号：US18673164

申请日：2024-05-23

Applicant: Genentech, Inc.

Inventor： Nicholas J. ARMSTRONG ,  Mayumi N. BOWEN ,  Yuh-Fun MAA

IPC: C07K16/40 ,  A61K9/00 ,  A61K9/10 ,  A61K9/16 ,  A61K39/395 ,  C07K16/22 ,  C07K16/28 ,  C07K16/32

Abstract: The present application discloses high-concentration monoclonal antibody formulations suitable for subcutaneous administration, e.g. via a pre-filled syringe. In particular, it discloses a formulation comprising a spray dried monoclonal antibody at a concentration of about 200 mg/mL or more suspended in a non-aqueous suspension vehicle where the viscocity of the suspension vehicle is less than about 20 centipoise. Also disclosed are: a subcutaneous administration device with the formulation therein, a method of making the formulation, a method of making an article of manufacture comprising the suspension formulation, use of the formulation in the preparation of a medicament, and a method of treating a patient with the formulation.

公开(公告)号：US20160176986A1

公开(公告)日：2016-06-23

申请号：US14752670

申请日：2015-06-26

Applicant: GENENTECH, INC.

Inventor： Nicholas J. ARMSTRONG ,  Mayumi N. BOWEN ,  Yuh-Fun MAA

IPC: C07K16/40 ,  C07K16/32 ,  C07K16/28 ,  C07K16/22

Abstract: The present application discloses high-concentration monoclonal antibody formulations suitable for subcutaneous administration, e.g. via a pre-filled syringe. In particular, it discloses a formulation comprising a spray dried monoclonal antibody at a concentration of about 200 mg/mL or more suspended in a non-aqueous suspension vehicle where the viscocity of the suspension vehicle is less than about 20 centipoise. Also disclosed are: a subcutaneous administration device with the formulation therein, a method of making the formulation, a method of making an article of manufacture comprising the suspension formulation, use of the formulation in the preparation of a medicament, and a method of treating a patient with the formulation.

Abstract translation: 本申请公开了适用于皮下给药的高浓度单克隆抗体制剂，例如， 通过预先填充的注射器。 特别地，其公开了一种制剂，其包含浓度为约200mg / mL或更高的喷雾干燥的单克隆抗体，其悬浮于非水悬浮液中，其中悬浮载体的粘度小于约20厘泊。 还公开了：其中具有制剂的皮下给药装置，制备制剂的方法，制备包含悬浮液制剂的制品的方法，制剂在制备药物中的用途，以及治疗方法 患者配方。