... than PCCs and are less thrombogenic in vitro. In this report, the results of clinical studies with Mononine (Armour Pharmaceutical Company), a purified factor IX concentrate prepared by monoclonal affinity chromatography, are described. Two studies were performed, a phase I/II clinical trial in 10...

... of this methodology, the steps included in the purification of the factor VIII concentrate Monoclate-P are reviewed and those used to purify the factor IX concentrate Mononine – monoclonal antibody chromatography, sodium thiocyanate incubation, and a novel ultrafiltration system – are described. Rigorous quality...