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PROCÉDÉ DE MICRONISATION
专利权人:
Omrix Biopharmaceuticals Ltd.
发明人:
申请号:
EP07827292.9
公开号:
EP2106296B1
申请日:
2007.10.30
申请国别(地区):
EP
年份:
2017
代理人:
摘要:
A method for micronization of a dispersion of particles including a protein having a predetermined level of biological activity, is provided. The method includes introducing the dispersion into a vortex chamber milling apparatus under milling conditions which result in a protein powder having a particle size distribution of 5 to 100 μm and/or exhibiting a 30 to 400 fold size reduction of the protein particle dispersion from its original size, and retaining at least 80% of the predetermined level of biological activity of the protein. The milling conditions include one or more parameters selected from the following: input pressure between 1 and 7 Bars; injector pressure between 0.2 and 5 Bars; loading rate between 0.1 and 5 kg/hour; and gas flow between 30 and 100 m3/hour.
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