CHEMICAL COMPOSITION BEING SUITABLE FOR MEDICAL TREATMENT CONTAINING VITAMIN K-DEPENDING PROTEIN

摘要

PURPOSE: To obtain a drug composition containing an active protein A in a state purified and concentrated in high purity from blood plasma or its concentrate and suitable for therapeutic use. CONSTITUTION: This drug composition for therapeutic use contains an active protein A purified and concentrated in high purity and obtained by carrying out the processes comprising (a) a step to adsorb the protein A from a source substance composed of a mixture of protein A and one or more other proteins B on a particulate adsorbent bonded to a monoclonal antibody having specificity to a protein A selected from vitamin K dependent proteins, (b) a step to remove the source substance free from the protein A from the particulate adsorbent using an aqueous buffer solution containing a chaotropic agent and (c) a step to recover the concentrated protein A composition by eluting the protein A adsorbed to the particulate adsorbent using an eluent. These steps are carried out in the absence of a protease inhibitor.