Powdered protein compositions and methods of making same

摘要

A method for preparing a protein or peptide powder is provided that includes spray drying a solution including more than, e.g., about 50 mg/mL of a protein or peptide (e.g., an antibody or antigen binding portion thereof), and at least one excipient. Also provided are stable powdered compositions including a protein and an excipient having less than, e.g., about 6% residual moisture.

主权项

1. A pharmaceutical powder preparation comprising an effective amount of adalimumab and sodium hyaluronate,
wherein the pharmaceutical powder preparation is prepared by spray drying a solution comprising more than about 50 mg/mL of adalimumab and an excipient which is either trehalose or sucrose, and wherein the pharmaceutical powder preparation has an excipient:adalimumab mass ratio of about 0.7:1.0 or about 1.4:1.0, comprises less than about 6% residual moisture, comprises no more than 2% aggregates upon reconstitution when stored as a powder at 25° C. for three months, and comprises no more than 5% aggregates upon reconstitution when stored as a powder at 40° C. for three months.