A very-high-purity von Willebrand factor preparation containing high-molecular-weight multimers

BACKGROUND AND OBJECTIVES: We investigated large-scale production of very-high-purity von Willebrand factor (vWf) containing high-molecular-weight vWf multimers, using chromatography alone. MATERIALS AND METHODS: Factor VIII (FVIII)-containing vWf was produced by initial separation of vWf from plasma by gel filtration followed by two ion exchange steps. Two virus inactivation steps were incorporated in the process. RESULTS: The process resulted in FVIII-containing vWf preparations with a mean specific activity of 82 U vWf: collagen-binding activity per milligram protein (excluding added albumin) and with almost intact vWf multimer distributions. CONCLUSIONS: Very-high-purity, double virus-inactivated vWf preparations containing high molecular weight multimers were obtained on a production scale.