Characterisation of a novel high-purity, double virus inactivated von Willebrand Factor and Factor VIII concentrate (Wilate®)
Characterisation of a novel high-purity, double virus inactivated von Willebrand Factor and Factor VIII concentrate (Wilate®)
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DOI:
10.1016/j.biologicals.2005.11.010
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发表时间:
2006-12-01
期刊:
影响因子:
1.7
通讯作者:
Svae, T. -E.
中科院分区:
文献类型:
--
作者:
Stadler, M.;Gruber, G.;Svae, T. -E.
This study summarises the biochemical and functional properties of a new generation plasma-derived, double virus inactivated von Willebrand Factor/Factor VIII (VWF/FVIII) concentrate, Wilate (R), targeted for the treatment of both von Willebrand disease (VWD) and haemophilia A. The manufacturing process comprises two chromatographic steps based on different performance principles, ensuring a high purity of the concentrate (mean specific activity in 15 consecutive production batches: 122 IU FVIII:C/mg total protein) and, thus, minimising the administered protein load to the patient (specification: