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1. 发明公开

EP3094639A1 METHOD FOR OPTIMIZING POST-TRANSLATIONAL MODIFICATIONS ON RECOMBINANT PROTEINS 审中-公开
标题翻译：方法以优化重组蛋白翻译后修饰
公开(公告)号：EP3094639A1
公开(公告)日：2016-11-23
申请号：EP15734830.1
申请日：2015-01-13
申请人： Leszcyniecka, Magdalena , Shulga-Morskoy, Sergey
发明人： Leszcyniecka, Magdalena , Shulga-Morskoy, Sergey
IPC分类号： C07K1/00 , C12N5/02 , C12P21/00
CPC分类号： C12P21/02 , C07K16/32 , C07K2317/14 , C07K2317/24 , C07K2317/41 , C12N2510/02 , G01N2440/00
摘要： A method for optimizing post-translational modifications of recombinant proteins expressed in living cells is described. More particularly, a method for modulation of host proteins in living cells that control PTMs on recombinant proteins is described that has particularly useful applications in developing manufacturing process changes or in biosimilar development. The goal of this modulation is to produce a recipe for production of a recombinant protein in the new process or in the biosimilar that will produce a targeted PTM profile in the resulting protein product. In the method one or more modulators are selected, as from a modulator library, which affect the activity of host proteins. These modulators are added to media during production such that the resulting product matches the PTMs of the reference product. The ideal set of modulators and their concentrations are identified through a unique iterative process and the combined modulators and their concentrations constitute a recipe for growth media for the production of said recombinant protein. The methodology to obtain such a recipe described herein may then be used in many applications, such as optimizing new batches of recombinant protein drugs, developing biosimilar or bio-better drugs.

2. 发明申请

WO2015106276A1 METHOD FOR OPTIMIZING POST-TRANSLATIONAL MODIFICATIONS ON RECOMBINANT PROTEINS 审中-公开
标题翻译：用于优化重组蛋白的翻译后修饰的方法
公开(公告)号：WO2015106276A1
公开(公告)日：2015-07-16
申请号：PCT/US2015/011226
申请日：2015-01-13
申请人： LESZCYNIECKA, Magdalena , SHULGA-MORSKOY, Sergey
发明人： LESZCYNIECKA, Magdalena , SHULGA-MORSKOY, Sergey
IPC分类号： C07K1/00 , C12N5/02 , C12P21/00
CPC分类号： C12P21/02 , C07K16/32 , C07K2317/14 , C07K2317/24 , C07K2317/41 , C12N2510/02 , G01N2440/00
摘要： A method for optimizing post-translational modifications of recombinant proteins expressed in living cells is described. More particularly, a method for modulation of host proteins in living cells that control PTMs on recombinant proteins is described that has particularly useful applications in developing manufacturing process changes or in biosimilar development. The goal of this modulation is to produce a recipe for production of a recombinant protein in the new process or in the biosimilar that will produce a targeted PTM profile in the resulting protein product. In the method one or more modulators are selected, as from a modulator library, which affect the activity of host proteins. These modulators are added to media during production such that the resulting product matches the PTMs of the reference product. The ideal set of modulators and their concentrations are identified through a unique iterative process and the combined modulators and their concentrations constitute a recipe for growth media for the production of said recombinant protein. The methodology to obtain such a recipe described herein may then be used in many applications, such as optimizing new batches of recombinant protein drugs, developing biosimilar or bio-better drugs.
摘要翻译：描述了用于优化活细胞中表达的重组蛋白的翻译后修饰的方法。更具体地说，描述了一种用于调节控制重组蛋白上的PTM的活细胞中的宿主蛋白的方法，其在开发制造过程变化或生物仿制发育中具有特别有用的应用。该调节的目标是产生在新方法或生物仿制品中生产重组蛋白质的配方，其将在所得蛋白质产物中产生靶向的PTM谱。在该方法中，从调节基因库中选择一种或多种调节剂，其调节宿主蛋白的活性。这些调制剂在生产过程中被添加到介质中，使得所得产品与参考产品的PTM匹配。调节剂及其浓度的理想组合通过独特的迭代过程进行鉴定，组合的调节剂及其浓度构成了用于生产所述重组蛋白的生长培养基的配方。获得这里描述的食谱的方法可以用于许多应用中，例如优化新批次的重组蛋白质药物，开发生物仿制药或生物更好的药物。

3. 发明公开

EP3094639A4 METHOD FOR OPTIMIZING POST-TRANSLATIONAL MODIFICATIONS ON RECOMBINANT PROTEINS 审中-公开
标题翻译： VERFAHREN ZUR OPTIMIERUNG DER POSTTRANSLATIONALEN MODIFIKATIONEN AUF REKOMBINANTEN PROTEINEN
公开(公告)号：EP3094639A4
公开(公告)日：2017-08-30
申请号：EP15734830
申请日：2015-01-13
申请人： LESZCYNIECKA MAGDALENA , SHULGA-MORSKOY SERGEY
发明人： LESZCYNIECKA MAGDALENA , SHULGA-MORSKOY SERGEY
IPC分类号： C07K1/00 , C12N5/02 , C12P21/00
CPC分类号： C12P21/02 , C07K16/32 , C07K2317/14 , C07K2317/24 , C07K2317/41 , C12N2510/02 , G01N2440/00
摘要： A method for optimizing post-translational modifications of recombinant proteins expressed in living cells is described. More particularly, a method for modulation of host proteins in living cells that control PTMs on recombinant proteins is described that has particularly useful applications in developing manufacturing process changes or in biosimilar development. The goal of this modulation is to produce a recipe for production of a recombinant protein in the new process or in the biosimilar that will produce a targeted PTM profile in the resulting protein product. In the method one or more modulators are selected, as from a modulator library, which affect the activity of host proteins. These modulators are added to media during production such that the resulting product matches the PTMs of the reference product. The ideal set of modulators and their concentrations are identified through a unique iterative process and the combined modulators and their concentrations constitute a recipe for growth media for the production of said recombinant protein. The methodology to obtain such a recipe described herein may then be used in many applications, such as optimizing new batches of recombinant protein drugs, developing biosimilar or bio-better drugs.
摘要翻译：描述了用于优化在活细胞中表达的重组蛋白的翻译后修饰的方法。更具体地说，描述了调控重组蛋白质上PTM的活细胞中宿主蛋白质的方法，该方法在开发生产过程改变或生物仿制药开发中具有特别有用的应用。这种调节的目的是为了在新工艺或生物仿制药中产生重组蛋白质生产配方，从而在所得蛋白质产品中产生靶向PTM特征。在该方法中，从调节物库中选择一种或多种调节剂，这些调节剂影响宿主蛋白质的活性。这些调制剂在生产过程中添加到介质中，以使得到的产品与参考产品的PTM匹配。通过独特的迭代过程鉴定理想的调节剂组及其浓度，并且组合的调节剂及其浓度构成用于生产所述重组蛋白的生长培养基的配方。然后可以在许多应用中使用获得这种配方的方法，例如优化新批次的重组蛋白药物，开发生物仿制药或生物更好的药物。

4. 发明专利

CA2936831A1 METHOD FOR OPTIMIZING POST-TRANSLATIONAL MODIFICATIONS ON RECOMBINANT PROTEINS 未知
公开(公告)号：CA2936831A1
公开(公告)日：2015-07-16
申请号：CA2936831
申请日：2015-01-13
申请人： SHULGA-MORSKOY SERGEY , LESZCYNIECKA MAGDALENA
发明人： SHULGA-MORSKOY SERGEY , LESZCYNIECKA MAGDALENA
IPC分类号： C07K1/00 , C12N5/02 , C12P21/00
摘要： A method for optimizing post-translational modifications of recombinant proteins expressed in living cells is described. More particularly, a method for modulation of host proteins in living cells that control PTMs on recombinant proteins is described that has particularly useful applications in developing manufacturing process changes or in biosimilar development. The goal of this modulation is to produce a recipe for production of a recombinant protein in the new process or in the biosimilar that will produce a targeted PTM profile in the resulting protein product. In the method one or more modulators are selected, as from a modulator library, which affect the activity of host proteins. These modulators are added to media during production such that the resulting product matches the PTMs of the reference product. The ideal set of modulators and their concentrations are identified through a unique iterative process and the combined modulators and their concentrations constitute a recipe for growth media for the production of said recombinant protein. The methodology to obtain such a recipe described herein may then be used in many applications, such as optimizing new batches of recombinant protein drugs, developing biosimilar or bio-better drugs.

5. 发明专利

AU2016101317A4 Method for optimizing post-translational modifications on recombinant proteins 未知
公开(公告)号：AU2016101317A4
公开(公告)日：2016-09-08
申请号：AU2016101317
申请日：2016-07-29
申请人： LESZCYNIECKA MAGDALENA , SHULGA MORSKOY SERGEY
发明人： LESZCYNIECKA MAGDALENA , SHULGA-MORSKOY SERGEY
IPC分类号： C07K1/00 , C12N5/02 , C12P21/00
摘要： METHOD FOR OPTIMIZING POST-TRANSLATIONAL MODIFICATIONS ON RECOMBINANT PROTEINS The present invention provides methods for optimization of cell culture processes to yield recombinant proteins with target PTMs that are uniquely useful for biosimilar development and manufacturing process changes. The method focuses on optimization of cell culture conditions via addition of modulator(s) to growth media containing living cells that produce proteins, such as recombinant proteins or biosimilar proteins. Addition of modulator(s) to the living cell culture medium can be used to reduce or augment the activity of specific host protein(s) that control PTMs on the biosimilar drug target.

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