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    • 9. 发明申请
    • PROCESS FOR PREPARING AN ADENOVIRUS-CONTAINING PREPARATION
    • 制备含有腺病毒的制剂的方法
    • WO2003106664A1
    • 2003-12-24
    • PCT/EP2003/006196
    • 2003-06-12
    • PROCORDE GMBHKIVINIEMI, JohannaBAUMGARTNER, ChristineSCHNEIDER, ErikaMÜNCH, GötzUNGERER, MartinROSPORT, Kai
    • KIVINIEMI, JohannaBAUMGARTNER, ChristineSCHNEIDER, ErikaMÜNCH, GötzUNGERER, MartinROSPORT, Kai
    • C12N7/02
    • C12N7/00A61K48/00C12N2710/10351
    • A process for preparing an adenovirus-containing preparation for in vivo somatic gene transfer to the myocardium or endothelium of large animals, comprising the steps of (i) generating adenovirus in a bioreactor under predetermined conditions for obtaining an adenovirus-containing medium; (ii) optionally separating of adenovirus from the adenovirus-containing medium of step (i) by filtration to obtain an adenovirus-containing filtrate; (iii) concentrating the adenovirus-containing medium of step (i) or the adenovirus-containing filtrate of step (ii) to obtain a adenovirus-containing concentrate; (iv) batch purification of the adenovirus-containing concentrate of step (iii) by a Fast Protein Liquid Chromatography (FPLC) in at least two steps at a pressure of less than 0.3 MPa and a volume of at least 200 ml to obtain an adenovirus-containing batch; (v) optionally concentrating the adenovirus-containing batch of step (iv) to obtain a concentrated adenovirus-containing batch; and (vi) optionally dialysis of the adenovirus-containing batch of step (iv) or the concentrated adenovirus-containing batch of step (v), to obtain an adenovirus-containing preparation.
    • 一种制备用于体内体细胞基因转移到大动物的心肌或内皮的腺病毒的制剂的方法,包括以下步骤:(i)在预定条件下在生物反应器中产生用于获得含腺病毒的培养基的腺病毒; (ii)通过过滤任选地从步骤(i)的含腺病毒的培养基中分离腺病毒以获得含腺病毒的滤液; (iii)浓缩步骤(i)的含腺病毒的培养基或步骤(ii)的含腺病毒的滤液以获得含腺病毒的浓缩物; (iv)通过快速蛋白质液相色谱(FPLC)在至少两个步骤中以小于0.3MPa的压力和至少200ml的体积批次纯化步骤(iii)的含腺病毒的浓缩物,以获得腺病毒 包含批次; (v)任选地浓缩步骤(iv)的含腺病毒的批次,以获得含有浓缩的含腺病毒的批料; 和(vi)任选地对步骤(iv)的含腺病毒的批次或含有步骤(v)的浓缩的含腺病毒的批次进行透析,以获得含腺病毒的制剂。