De Staat der Nederlanden; vert. door de minister van VWS; Welzijn en Sport; Ministerie van Volksgezondheid
发明人:
Heleen Kraan,Jean-Pierre Amorij
申请号：
US14382258
公开号：
US09827303B2
申请日:
2013.03.05
申请国别(地区):
US
年份:
2017
代理人:
摘要：
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.
