Login| Sign Up| Help| Contact|

Patent Searching and Data


Title:
TARGET RESIDUAL MOISTURE CONTENT FOR LYOPHILIZED DRUG PRODUCT
Document Type and Number:
WIPO Patent Application WO/2021/158759
Kind Code:
A3
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.

Inventors:
TANG XIAOLIN (US)
KLEPPE MARY (US)
CHARI RAVI (US)
TZUL FRANCO (US)
Application Number:
PCT/US2021/016569
Publication Date:
October 07, 2021
Filing Date:
February 04, 2021
Export Citation:
Click for automatic bibliography generation   Help
Assignee:
REGENERON PHARMA (US)
International Classes:
F26B5/04; F26B5/06; F26B25/22
Attorney, Agent or Firm:
CAPLAN, Jonathan S. (US)
Download PDF: