Target residual moisture content for lyophilized drug product
AssigneeRegeneron Pharmaceuticals, Inc.
InventorsXiaolin Tang, Mary Kleppe, Ravi Chari, Franco Tzul
Life of this patent
Estimating the term…
Abstract
Lyophilization methods for preparing protein formulations for long-term storage at room temperature or improved stability at refrigeration storage are provided. Specifically, the present application provides lyophilization methods to obtain a target percentage of residual moisture of a lyophilized product, such as 3-5% residual moisture. The secondary drying of the lyophilization can be conducted under controlling rate of desorption under a temperature which is similar to the shelf temperature of the primary drying. Alternatively, the lyophilization can be conducted without a distinguished secondary drying step.
Claims19
A method for producing a lyophilized drug product, comprising:
- obtaining a formulation comprising a formulated drug substance;
- and
- subjecting the formulation to lyophilization to produce a lyophilized drug product, wherein the lyophilization comprises a first drying step and a secondary drying step, wherein the secondary drying step is conducted at a temperature below about 0° C., and the lyophilized drug product comprises a moisture content from about 3% to about 5%.
Dependencies are inferred from the claim text.