- Patent Title: Methods and compositions for stabilizing dried biological materials
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Application No.: US15795545Application Date: 2017-10-27
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Publication No.: US10335479B2Publication Date: 2019-07-02
- Inventor: Heleen Kraan , Jean-Pierre Amorij , Rimko Ten Have
- Applicant: De Staat der Nederlanden, Vert. Door De Minister Van VWS Ministerie van Volksgezondheid, Welzijn en Sport
- Applicant Address: NL The Hague
- Assignee: De Staat der Nederlanden, Vert. Door De Minister Van VWS Ministerie van Volksgezondheid, Welzijn en Sport
- Current Assignee: De Staat der Nederlanden, Vert. Door De Minister Van VWS Ministerie van Volksgezondheid, Welzijn en Sport
- Current Assignee Address: NL The Hague
- Agency: Foley & Lardner LLP
- Agent Giberto M. Villacorta; Sunit Talapatra
- Priority: EP12158086 20120305
- Main IPC: A61K39/13
- IPC: A61K39/13 ; A61K47/02 ; A61K47/18 ; A61K47/26 ; A61K9/19 ; C12N7/00 ; A61K39/12

Abstract:
The present invention relates to methods for producing dried formulations of biopharmaceutical agents that aim to minimize the loss of activity of the agents upon drying and to provide dried formulations with an extended shelf life. The method comprises the step of drying an aqueous solution comprising, in addition to the biopharmaceutical agent, at least an amino acid, a polyol and a metal salt. Preferably the amino acid is glutamate, the polyol is sorbitol and optionally also mannitol and the metal salt is a magnesium salt. The solution is dried by vacuum drying or by lyophilization. The methods are particularly useful for preparing dried formulations of viruses such as poliovirus or respiratory syncytial virus to be used for vaccination. The invention also relates to dried formulations prepared in accordance with the methods of the invention and to their use as medicaments, e.g. as vaccines.
Public/Granted literature
- US20180055924A1 METHODS AND COMPOSITIONS FOR STABILIZING DRIED BIOLOGICAL MATERIALS Public/Granted day:2018-03-01
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