Highly Glycosylated Long-Acting Human Growth Hormone Protein and Production Method for Same
    6.
    发明申请
    Highly Glycosylated Long-Acting Human Growth Hormone Protein and Production Method for Same 有权
    高度糖基化的长效人类生长激素蛋白及其生产方法

    公开(公告)号:US20150126715A1

    公开(公告)日:2015-05-07

    申请号:US14406192

    申请日:2013-06-05

    摘要: The present invention relates to a long-acting human growth hormone NexP-hGH protein and its production method. More specifically, it relates to a specific isoform of long-acting human growth hormone NexP-hGH protein in which human growth hormone is fused with a highly glycosylated alpha-1 antitrypsin mutant whereby long-acting properties in vivo are increased. The present invention also relates to a high-purity purification method for NexP-hGH, which includes the steps of: (a) carrying out anion-exchange resin chromatography on a biological emulsion comprising NexP-hGH in which human growth hormone is fused with an alpha-1 antitrypsin mutant; (b) carrying out hydrophobic resin chromatography on the biological emulsion comprising NexP-hGH, or on the eluate produced in step (a); and (c) carrying out affinity chromatography, entailing packing with a resin to which anti-alpha-1 antitrypsin antibody fragments are attached, on the biological emulsion comprising NexP-hGH and on the eluate produced in step (a) or step (b).

    摘要翻译: 本发明涉及长效人生长激素NexP-hGH蛋白及其制备方法。 更具体地说,它涉及长效人生长激素NexP-hGH蛋白的特异性同种型,其中人生长激素与高度糖基化的α-1抗胰蛋白酶突变体融合,由此体内长效特性增加。 本发明还涉及一种用于NexP-hGH的高纯度纯化方法,其包括以下步骤:(a)在包含NexP-hGH的生物乳液上进行阴离子交换树脂色谱法,其中人生长激素与 α-1抗胰蛋白酶突变体; (b)对包含NexP-hGH的生物乳液或在步骤(a)中产生的洗脱液上进行疏水性树脂色谱法; 和(c)进行亲和层析,使包含与抗-α-1抗胰蛋白酶抗体片段相连的树脂包含在包含NexP-hGH的生物乳液和步骤(a)或步骤(b)中产生的洗脱液上) 。