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Characterization of protein unable to bind von Willebrand factor in recombinant factor VIII products

Therapeutic products with coagulation factor VIII (FVIII) have a wide range of specific activities, implying presence of protein with altered structure. Previous studies showed that recombinant FVIII products (rFVIII) contain a fraction (FVIIIFT) unable to bind von Willebrand factor (VWF) and reported to lack activity. Because of loss of function(s), FVIIIFT can be defined as a product‐related impurity, whose properties and levels in rFVIII products should be investigated.