Very-high-purity, double virus-inactivated vWf preparations containing high molecular weight multimers were obtained on a production scale.

No abstract

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.