A process for the production of human interferon alpha from...

C - Chemistry – Metallurgy – 12 – N

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C12N 15/00 (2006.01) C07K 14/47 (2006.01) C07K 14/555 (2006.01) C07K 14/56 (2006.01) C12N 1/15 (2006.01) C12N 1/16 (2006.01) C12N 5/10 (2006.01) C12P 21/02 (2006.01)

Patent

CA 2402562

A process for the production of physiologically-active human interferon alpha from genetically engineered yeast, Pichia pastoris, comprising digesting, with an enzyme to produce a linearized plasmid, a plasmid having a promoter and operationally linked to a human interferon alpha gene in the absence of a fusion region; transforming Pichia pastoris cells with the linearized plasmid by homologous recombination to form Pichia pastoris clones; screening the Pichia pastoris clones for high interferon alpha expression to find a high interferon-yielding Pichia pastoris clone; growing the high interferon- yielding Pichia pastoris clone; and purifying physiologically-active human interferon alpha protein from the high interferon-yielding Pichia pastoris clones.

La présente invention concerne un procédé permettant de produire de l'interféron alpha humain actif du point de vue physiologique, à partir de levure génétiquement modifiée, Pichia pastoris, ledit procédé comprenant : la digestion, au moyen d'une enzyme permettant de produire un plasmide linéaire, d'un plasmide présentant un promoteur et étant éventuellement lié à un gène d'interféron alpha humain, en l'absence d'une zone de fusion ; la transformation des cellules Pichia pastoris avec le plasmide linéaire par recombinaison homologue pour former des clones dePichia pastoris ; le criblage des clones de Pichia pastoris afin d'obtenir un taux d'expression d'interféron alpha élevé dans le but de détecter un clone de Pichia pastoris à haut rendement en interféron ; la croissance du clone de Pichia pastoris à haut rendement en interféron ; et la purification de la protéine d'interféron alpha humain à action physiologique à partir des clones de Pichia pastoris à haut rendement en interféron.

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