公开(公告)号：US09902753B2

公开(公告)日：2018-02-27

申请号：US14406192

申请日：2013-06-05

申请人： CJ HEALTHCARE CORPORATION ,  ALTEOGEN, INC

发明人： Gil Bu Kang ,  Chung Min Lee ,  Jee Won Ahn ,  Dong Eok Lee ,  Chang Bong Jun ,  Won Jeong Lee ,  Sung Yoo Cho ,  Chi Hye Park ,  Ki Wan Kim ,  Yoon Jung Lee ,  Ji Hyun Moon ,  Hoo Keun Oh ,  Young Joon Park ,  Sang Hyun Lee ,  Hyoung Taek Lim ,  Soon Jae Park ,  Hye Shin Chung ,  Sang Mee Lee

IPC分类号： C07K1/22 ,  C07K1/16 ,  C07K14/61 ,  C07K19/00 ,  C07K1/14 ,  C07K14/81

CPC分类号： C07K1/16 ,  C07K1/14 ,  C07K14/61 ,  C07K14/8125 ,  C07K19/00 ,  C07K2319/00

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).

公开(公告)号：US20150126715A1

公开(公告)日：2015-05-07

申请号：US14406192

申请日：2013-06-05

申请人： CJ HEALTHCARE CORPORATION ,  ALTEOGEN, INC.

发明人： Gil Bu Kang ,  Chung Min Lee ,  Jee Won Ahn ,  Dong Eok Lee ,  Chang Bong Jun ,  Won Jeong Lee ,  Sung Yoo Cho ,  Chi Hye Park ,  Ki Wan Kim ,  Yoon Jung Lee ,  Ji Hyun Moon ,  Hoo Keun Oh ,  Young Joon Park ,  Sang Hyun Lee ,  Hyoung Taek Lim ,  Soon Jae Park ,  Hye Shin Chung ,  Sang Mee Lee

IPC分类号： C07K1/16 ,  C07K19/00 ,  C07K1/14 ,  C07K14/61

CPC分类号： C07K1/16 ,  C07K1/14 ,  C07K14/61 ,  C07K14/8125 ,  C07K19/00 ,  C07K2319/00

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） 。