Evaluation of the virus clearance capacity and robustness of the manufacturing process for the recombinant factor VIII protein, turoctocog alfa
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- 作者：Tracey W. Ellgaard ; tryw@novonordisk.com" class="auth_mail" title="E-mail the corresponding author ; Lene Bindslev lnbi@novonordisk.com" class="auth_mail" title="E-mail the corresponding author ; Sø ; ren Kamstrup skam@novonordisk.com" class="auth_mail" title="E-mail the corresponding author
- 关键词：Turoctocog alfa ; Manufacture ; Virus clearance ; rFVIII ; Virus safety ; Virus clearance evaluation
- 刊名：Protein Expression and Purification
- 出版年：2017
- 出版时间：January 2017
- 年：2017
- 卷：129
- 期：Complete
- 页码：94-100
- 全文大小：570 K
文摘
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The virus clearance of the turoctocog alfa purification process was assessed.
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Viruses with different sizes and properties were used: eMuLV, MVM, Reo-3, BEV, IBRV.
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All viruses were effectively removed through a combination of orthogonal steps.
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Virus clearance is robust with respect to process variation and re-use of resins.
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Effective and robust virus clearance is important for the safety of turoctocog alfa.
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