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公开(公告)号：US09902753B2
公开(公告)日：2018-02-27
申请号：US14406192
申请日：2013-06-05
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
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).
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2.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
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
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） 。
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公开(公告)号：US10723775B2
公开(公告)日：2020-07-28
申请号：US15039569
申请日：2014-11-28
发明人： Yoon Jung Lee , Kyung Hwa Kim , Yoo Hee Yang , Jung Min Yoo , Se Jun Kim , Ji Hyun Moon , Hoo Keun Oh , Dong Eok Lee , Won Jeong Lee , Jung Rok Lee , Chung Min Lee , Eun Young Choi , Gyong Sik Ha
IPC分类号： C07K1/18 , C07K1/34 , C07K14/505
摘要： The present invention relates to a method for purifying darbepoetin alfa by selectively separating only a structural isoform having a high content of sialic acid from a mixture of structural isoforms of darbepoetin alfa having various contents of sialic acid. Since the method of the present invention is a novel method for purifying darbepoetin alfa which can be conveniently and simply produced, it is possible to remarkably increase productivity due to process efficiency improvement, as well as to yield high purity darbepoetin alfa when mass-producing darbepoetin alfa according to the present invention.
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公开(公告)号：US20170022257A1
公开(公告)日：2017-01-26
申请号：US15039569
申请日：2014-11-28
发明人： Yoon Jung Lee , Kyung Hwa Kim , Yoo Hee Yang , Jung Min Yoo , Se Jun Kim , Ji Hyun Moon , Hoo Keun Oh , Dong Eok Lee , Won Jeong Lee , Jung Rok Lee , Chung Min Lee , Eun Young Choi , Gyong Sik Ha
IPC分类号： C07K14/505 , C07K1/18
摘要： The present invention relates to a method for purifying darbepoetin alfa by selectively separating only a structural isoform having a high content of sialic acid from a mixture of structural isoforms of darbepoetin alfa having various contents of sialic acid. Since the method of the present invention is a novel method for purifying darbepoetin alfa which can be conveniently and simply produced, it is possible to remarkably increase productivity due to process efficiency improvement, as well as to yield high purity darbepoetin alfa when mass-producing darbepoetin alfa according to the present invention.
摘要翻译： 本发明涉及通过从具有各种唾液酸含量的达贝泊汀α的结构亚型的混合物中选择性分离具有高唾液酸含量的结构同种型来纯化达贝泊汀的方法。 由于本发明的方法是一种纯化达贝泊汀α的方法简单生产的新方法，因此可以显着提高生产效率，同时产生高产量的达贝泊汀α 阿尔法。
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