Target residual moisture content for lyophilized drug product

US11525629B2 · kind B2 · utility

Assignee

• REGENERON PHARMACEUTICALS, INC. · US

Inventors

• Xiaolin Tang · Old Tappan, US
• Mary Kleppe · Kingston, US
• Ravi V. J. Chari · Newton, US
• Franco Tzul · Hartsdale, US

Key dates

• Filing date: Feb 4, 2021
• Grant date: Dec 13, 2022
• Expiry date: Jun 17, 2041

Classification

• Technology area (CPC F): Mechanical Engineering; Lighting; Heating
• CPC primary: F26B25/22
• WIPO field: Pharmaceuticals
• WIPO sector: Chemistry

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.