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Procedimiento para la fabricación de un fármaco proteínico
专利权人:
Asahi Kasei Medical Co.; Ltd.
发明人:
HONGO, Tomoko,HAYASHIDA, Hirohisa
申请号:
ES12803267
公开号:
ES2641042T8
申请日:
2012.06.22
申请国别(地区):
ES
年份:
2018
代理人:
摘要:
The present invention provides a method for manufacturing a virus-free protein drug, comprising (a) a filtration step of filtering a virus-containing protein solution through a small-pore size virus removal membrane to obtain a virus-free protein solution, the filtration step (a) comprising (q) a low-pressure filtration step of filtering the solution through the small-pore size virus removal membrane at a filtration pressure of 0.30 kgf/cm 2 or lower to obtain the virus-free protein solution, wherein the solution prior to filtration in the low-pressure filtration step (q) has a pH (X) and a salt ionic strength (Y (mM)) that satisfy the following equations 1 and 5: 0 ‰¤ Y ‰¤ 150X - 590 (Equation 1) and 3.5 ‰¤ X ‰¤ 8.0 (Equation 5) or the following equations 4 and 5: Y = 0 (Equation 4) and 3.5 ‰¤ X ‰¤ 8.0 (Equation 5).
来源网站:
中国工程科技知识中心
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