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STABILIZATION OF FACTOR VIII WITHOUT CALCIUM AS AN EXCIPIENT
专利权人:
发明人:
NAYAR RAJIV
申请号:
IN201627037133
公开号:
IN201627037133A
申请日:
2016.10.28
申请国别(地区):
IN
年份:
2016
代理人:
摘要:
The present invention provides a novel albumin free formulation of recombinant Factor VIII that does not require calcium ions as an added formulation excipient. The absence of calcium chloride in the formulation results in a number of improvements and benefits for a Factor VIII formulation. This invention allows a Factor VIII formulation that can be lyophilized more efficiently as the absence of calcium ions will increase primary glass transition of the amorphous phase. The absence of free calcium ions in the formulation will also improve the stability of the formulation as metal dependent oxidation reactions will be avoided and the protein molecule will not be subjected to chemical instabilities. Finally the absence of calcium will further simplify the Factor VIII formulation by reducing the number of excipients in the formulation.
来源网站:
中国工程科技知识中心
来源网址:
http://www.ckcest.cn/home/

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