C - Chemistry – Metallurgy – 07 – K
Patent
C - Chemistry, Metallurgy
07
K
C07K 1/16 (2006.01) C07K 1/18 (2006.01) C07K 1/30 (2006.01) C07K 14/81 (2006.01)
Patent
CA 2432641
Purification of .alpha.-1 proteinase inhibitor (.alpha.-1 PI) from aqueous solutions, such as human plasma, is accomplished by precipitation of contaminating proteins from the aqueous solution, followed by dilution of the solution to adjust its conductivity, and passing of the solution through an anion exchange resin. The conductivity of the solution is adjusted so that the .alpha.-1 PI binds to the anion exchange resin, while other contaminating proteins and solvent pass though the resin. Further purification may be accomplished by cation chromatography, which takes advantage of the fact that .alpha.-1 PI does not bind to the cation column under certain conditions. Some embodiments of the invention also include virus removal and/or inactivation by methods such as nanofiltration and such as contact with a non-ionic detergent. The methods of the present invention result in greater yield, purity, and pathogenic clearance of plasma fractions than known methods.
La présente invention concerne la purification de l'inhibiteur de protéinase .alpha.-1 ou ".alpha.-1 PI" à partir de solutions aqueuses telles que le plasma humain. On commence par la précipitation des protéines contaminantes de la solution aqueuse, suivie d'une dilution de la solution pour corriger sa conductivité, puis on fait passer la solution par une résine échangeuse d'anions. La conductivité de la solution est corrigée de façon que le .alpha.-1 PI se lie à la résine échangeuse d'anions, les autres protéines contaminantes et le solvant traversant la résine. En outre, on peut réaliser la purification par chromatographie cationique en profitant du fait que le .alpha.-1 PI ne se lie pas à la colonne de cations sous certaines conditions. Certains modes de réalisation de l'invention portent également sur l'élimination et/ou l'inactivation de virus grâce à des procédés tels que la nanofiltration et que le contact avec un détergent non-ionique. Les procédés selon l'invention se distinguent par rapport aux procédés connus par une amélioration du rendement, de la pureté, et du filtrage des pathogènes dans les fractions plasma.
Chavez Mark D.
Lebing Wytold
Ownby David W.
Trukawinski Susan
Wood Woody D.
Borden Ladner Gervais Llp
Corporation Bayer
Talecris Biotherapeutics Inc.
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