Method of preparing alpha-1 proteinase inhibitor

C - Chemistry – Metallurgy – 07 – K

Patent

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C07K 1/16 (2006.01)

Patent

CA 2730018

Purification of .alpha.-1 proteinase inhibitor (.alpha.-1 PI) from solutions comprising .alpha.-1 PI is accomplished using hydrophobic interaction chromatography (HIC). In some embodiments, purification of .alpha.- 1 PI is accomplished by precipitation of contaminating proteins from a starting solution comprising .alpha.-1 PI, such as human plasma, followed by anion exchange resin chromatography prior to HIC. Further purification may be accomplished by an optional cation exchange chromatography subsequent to anion exchange chromatography but prior to HIC. Some embodiments of the invention also include virus removal and/or inactivation by methods such as nano filtration 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.

L'invention concerne une purification de l'inhibiteur d'a-1 protéinase (a-1 PI) à partir de solutions comprenant a-1 PI, qui est accomplie en utilisant une chromatographie d'interaction hydrophobe (HIC). Dans certains modes de réalisation, une purification de a-1 PI est accomplie par précipitation de protéines contaminantes depuis une solution de départ comprenant a-1 PI, comme du plasma humain, suivie par une chromatographie par résine échangeuse d'anions avant la HIC. Une purification supplémentaire peut être accomplie par une chromatographie par échange de cations facultative à la suite de la chromatographie par échange d'anions, mais avant la HIC. Certains modes de réalisation de l'invention comprennent également un enlèvement et/ou une inactivation de virus par des procédés comme une nanofiltration, et comme un contact avec un détergent non ionique. Les procédés de la présente invention ont pour résultat un rendement, une pureté et un filtrage des pathogènes à partir de fractions de plasma, supérieurs par rapport à des procédés connus.

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