METHOD OF PRODUCING A HIGHLY PURIFIED RECOMBINANT INHIBITOR OF HUMAN C1 ESTERASE

摘要

The invention relates to the field of biotechnology, specifically to the problem of creating effective technologies for producing highly purified protein drugs for medical use. Proposed is a new scheme for purifying a recombinant inhibitor of human C1 esterase that makes it possible to produce a drug containing not more than 10 ng/mg of host cell protein, not more than 5 pg/mg of host cell DNA, not less than 99.0% of a monomeric form, and not less than 99.5% of a major form as measured by reverse-phase HPLC, and having a specific activity of at least 9.0 IU/mg. The yield of the target protein from the content in the culture fluid comprises not less than 80%, which ensures that the resulting product has a low production cost. The invention can be used in the pharmaceutical industry, specifically in creating a drug for the treatment of hereditary angioneurotic edema (Quincke's edema).