Stable Protein Formulations
First Claim
Patent Images
1. A stable formulation suitable for subcutaneous administration comprising at least 100 mg/ml CTLA4Ig molecules, a sugar capable of stabilizing said formulation at a concentration effective therefore and a pharmaceutically acceptable aqueous carrier.
1 Assignment
0 Petitions
Accused Products
Abstract
The present invention relates generally to stable formulations comprising CTLA4Ig molecules, including lyophilized, and liquid formulations for administration via various routes including, for example, routes such as intravenous (IV) and subcutaneous (SC) for treating immune system diseases and tolerance induction.
55 Citations
77 Claims
- 1. A stable formulation suitable for subcutaneous administration comprising at least 100 mg/ml CTLA4Ig molecules, a sugar capable of stabilizing said formulation at a concentration effective therefore and a pharmaceutically acceptable aqueous carrier.
-
15. A stable formulation comprising the CTLA4Ig molecule having the amino acid sequence shown in SEQ ID NO:
- 2 starting at methionine at position 27 or alanine at position 26 and ending at lysine at position 383 or glycine at position 382 in an amount of about 125 mg/ml, sucrose in an amount of about 170 mg/ml, at least one buffering agent, sterile water for injection and optionally a surfactant.
- View Dependent Claims (16, 17, 18)
-
19. A stable formulation comprising LE104A29YIg molecule having the amino acid sequence shown in SEQ ID NO:
- 4 starting at methionine at position 27 or alanine at position 26 and ending at lysine at position 383 or glycine at position 382 in an amount of about 125 mg/ml, sucrose in an amount of about 170 mg/ml, at least one buffering agent, sterile water for injection and optionally a surfactant.
- View Dependent Claims (20, 21, 22)
- 26. A stable formulation suitable for dilution prior to intravenous administration comprising at least 20 mg/ml of CTLA4Ig molecules, a sugar capable of stabilizing said formulation at a concentration effective therefore and a pharmaceutically acceptable aqueous carrier
-
39. A stable formulation comprising CTLA4Ig molecule having the amino acid sequence shown in SEQ ID NO:
- 2 starting at methionine at position 27 or alanine at position 26 and ending at lysine at position 383 or glycine at position 382 in an amount of about 20 mg/ml, sucrose in an amount of about 40 mg/ml, at least one buffering agent, sterile water for injection and optionally a surfactant.
- View Dependent Claims (40, 41, 42)
-
43. A stable formulation comprising LE104A29YIg molecule having the amino acid sequence shown in SEQ ID NO:
- 4 starting at methionine at position 27 or alanine at position 26 and ending at lysine at position 383 or glycine at position 382 in an amount of about 20 mg/ml, sucrose in an amount of about 40 mg/ml, at least one buffering agent, sterile water for injection and optionally a surfactant.
- View Dependent Claims (44, 45, 46)
-
51. A stable lyophilized formulation for dilution prior to intravenous administration comprising soluble CTLA4Ig molecule and a lyoprotectant selected from the group consisting of sucrose, lactose, maltose, and trehalose, wherein the lyoprotectant is at a minimum weight ratio of 1:
- 2 protein to lyoprotectant.
- View Dependent Claims (52, 53, 54, 55, 56, 57, 58, 59, 60, 69, 70, 71, 72)
-
61. A stable lyophilized formulation comprising CTLA4Ig molecule having the amino acid sequence shown in SEQ ID NO:
- 2 starting at methionine at position 27 or alanine at position 26 and ending at lysine at position 383 or glycine at position 382 in an amount of about 262 mg/vial, maltose in an amount of about 525 mg/vial, at least one buffering agent, and optionally a surfactant.
- View Dependent Claims (62, 63, 64)
-
65. A stable lyophilized formulation comprising LE104A29Y molecule having the amino acid sequence shown in SEQ ID NO:
- 4 starting at methionine at position 27 or alanine at position 26 and ending at lysine at position 383 or glycine at position 382 in an amount of about 110 mg/vial, sucrose in an amount of about 220 mg/vial, at least one buffering agent and optionally a surfactant.
- View Dependent Claims (66, 67, 68)
Specification