A process for purifying vitamin k dependent proteins such as coagulation factor ix

摘要

A process of manufacturing a prion-free Vitamin K dependent Protein in a purification sequence employing chromatography characterized in that - at least one chromatography step is performed using a multimodal resin - providing a fraction containing Vitamin K dependent Protein in an aqueous solution; - contacting the fraction containing the Vitamin K dependent Protein with a multimodal resin at a pH between 6-9; - optionally washing the multimodal resin having the Vitamin K dependent Protein adsorbed with an aqueous washing buffer to wash away contaminants and retain the Vitamin K dependent Protein, before the Vitamin K dependent Protein is eluted; - the Vitamin K dependent Protein is eluting from the multimodal resin at a pH between 6 to 9 in a buffer comprising arginine; and - optionally collecting Vitamin K dependent Protein containing fractions in purified or enriched form.