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1. 发明申请

US20180180626A1 A METHOD FOR DEVELOPMENT OF RECOMBINANT PROTEINS WITH FINGERPRINT LIKE SIMILARITY TO THE REFERENCE PRODUCT 审中-公开
公开(公告)号：US20180180626A1
公开(公告)日：2018-06-28
申请号：US15322857
申请日：2015-07-01
申请人： STC Biologics, Inc.
发明人： Magdalena Leszczyniecka , Zahra Shahrokh
IPC分类号： G01N33/68 , C12P21/00
CPC分类号： G01N33/6842 , C12P21/00 , G01N33/6848
摘要： The present invention relates to the methods of developing recombinant proteins with a fingerprint like similarity to the reference product or the originator. The method is particularly useful in the development of biosimilar products. This method can also be used to establish comparability during the manufacturing process change for the originator products. Hie methods described herein are used to obtain a recipe for the production of a biosimilar product or a recombinant protein using a process that may be different from the original but that yields a recombinant protein that has fingerprint level of similarity to the reference product. The methods described herein can also used to obtain a fingerprinting analysis package for a biosimilar that can be submitted to regulatory agency for abbreviated biosimilar approval. While currently available analytical methods can identify and quantitate specific modifications on a recombinant, protein, no methods currently exist to measure and determine the concentration of product variants in a complex: mixture. The analytical methods described herein provide for identification and quantitation of the modifications of the recombinant proteins and of product variants in a complex mixture by utilizing various in silico computational approaches to transform analytical data and derive product variant distribution.

2. 发明申请

US20190000989A1 BISPECIFIC TARGETING AGENTS AND METHODS FOR THEIR PREPARATION 审中-公开
公开(公告)号：US20190000989A1
公开(公告)日：2019-01-03
申请号：US16069119
申请日：2017-01-11
申请人： STC Biologics Inc.
发明人： Magdalena Leszczyniecka , Thomas J. Schneider , Lisa Ganley-Leal
IPC分类号： A61K47/69 , A61K47/68 , A61K38/20 , C07K16/46
摘要： The present invention is directed to a platform for new bispecific targeting agents using liposomes or nanoparticles as linkers. The bispecific targeting agent can bind two different cell types, each via a separate targeting moiety. Said targeting agents can be used to induce specific biological effects in the cells such as cell proliferation or cell activation which can be used in some instances to destroy the other bound cells. Any cell that can be targeted can be subject to targeting. For example, the cell types that may be recruited by the bispecific targeting agent may be both human or one of the cells may be human and the other an infected cell or it can be an infectious agent. The platform is based on an empty nanoparticle or liposome conjugated to two or more targeting moieties, bound to the nanoparticle/liposome at defined ratios that may be other than 1:1. Such, compositions provide for specific binding to each cell type. This bispecific targeting agent can further be linked to growth factors or cytokines to further potentiate the effect of the bispecific targeting agent as a therapeutic or to exert a specific biologic effect on one or both cells being targeted.

3. 发明授权

US09868973B2 Method for optimizing post-translational modifications on recombinant proteins 有权
公开(公告)号：US09868973B2
公开(公告)日：2018-01-16
申请号：US15111260
申请日：2015-01-13
申请人： STC Biologics, Inc.
发明人： Magdalena Leszcyniecka , Sergey Shulga-Morskoy
IPC分类号： G01N33/68 , C12P21/02 , C07K16/32
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.

4. 发明申请

WO2016004242A1 A METHOD FOR DEVELOPMENT OF RECOMBINANT PROTEINS WITH FINGERPRINT LIKE SIMILARITY TO THE REFERENCE PRODUCT 审中-公开
标题翻译：用于指纹识别的重组蛋白的方法与参考产物的相似性
公开(公告)号：WO2016004242A1
公开(公告)日：2016-01-07
申请号：PCT/US2015/038888
申请日：2015-07-01
申请人： STC BIOLOGICS, INC.
发明人： LESZCZYNIECKA, Magdalena , SHAHROKH, Zahra
IPC分类号： C12P21/00 , G01N27/62 , G01N33/68
CPC分类号： G01N33/6842 , C12P21/00 , G01N33/6848
摘要： The present invention relates to the methods of developing recombinant proteins with a fingerprint like similarity to the reference product or the originator. The method is particularly useful in the development of biosimilar products. This method can also be used to establish comparability during the manufacturing process change for the originator products. Hie methods described herein are used to obtain a recipe for the production of a biosimilar product or a recombinant protein using a process that may be different from the original but that yields a recombinant protein that has fingerprint level of similarity to the reference product. The methods described herein can also used to obtain a fingerprinting analysis package for a biosimilar that can be submitted to regulatory agency for abbreviated biosimilar approval. While currently available analytical methods can identify and quantitate specific modifications on a recombinant, protein, no methods currently exist to measure and determine the concentration of product variants in a complex: mixture. The analytical methods described herein provide for identification and quantitation of the modifications of the recombinant proteins and of product variants in a complex mixture by utilizing various in silico computational approaches to transform analytical data and derive product variant distribution.
摘要翻译：本发明涉及开发具有与参考产品或发起者相似的指纹的重组蛋白质的方法。该方法在生物仿制品的开发中特别有用。该方法也可用于在发起产品的制造过程变更过程中建立可比性。本文所述的Hie方法用于获得生物仿制品或重组蛋白质的制备方法，所述方法可使用与原始方法不同的方法，但是产生与参照产物具有相似性指纹水平的重组蛋白质。本文所述的方法还可以用于获得生物仿制药的指纹分析包，其可以提交给监管机构进行缩写生物仿制批准。虽然目前可用的分析方法可以鉴定和定量重组蛋白质的特定修饰，但目前没有方法来测量和确定复合物中混合物中产物变体的浓度。本文所述的分析方法通过利用各种计算机计算方法来转化分析数据并得出产物变体分布来提供复杂混合物中重组蛋白质和产物变体的修饰的鉴定和定量。

5. 发明申请

WO2017123627A1 BISPECIFIC TARGETING AGENTS AND METHODS FOR THEIR PREPARATION 审中-公开
标题翻译：双特异性靶向剂及其制备方法
公开(公告)号：WO2017123627A1
公开(公告)日：2017-07-20
申请号：PCT/US2017/013006
申请日：2017-01-11
申请人： STC BIOLOGICS, INC.
发明人： LESZCZNIECKA, Magdalena , SCHNEIDER, Thomas, J. , GANLEY-LEAL, Lisa
IPC分类号： A61K39/44 , A61K47/66 , A61K47/68 , A61K47/69 , C07K16/30 , C07K16/34
CPC分类号： C07K16/2851 , A61K47/6849 , A61K47/6851 , A61K47/6855 , A61K47/6913 , A61K47/6935 , C07K16/00 , C07K16/2803 , C07K16/2815 , C07K16/2833 , C07K16/32 , C07K2317/31
摘要： The present invention is directed to a platform for new bispecific targeting agents using liposomes or nanoparticles as linkers. The bispecific targeting agent can bind two different cel l types, each via a separate targeting moiety. Said targeting agents can be used to induce specific biological effects in the cells such as cell proliferation or cell activation which can be used in some instances to destroy the other bound cells. Any cell that can be targeted can be subject to targeting. For example, the cell types that may be recruited by the bispecific targeting agent may be both human or one of the cells may be human and the other an infected cell or it can be an infectious agent. The platform is based on an empty nanoparticle or liposome conjugated to two or more targeting moieties, bound to the nanoparticle/liposome at defined ratios that may be other than 1:1. Such, compositions provide for specific binding to each cell type. This bispecific targeting agent can further be linked to growth factors or cytokines to further potentiate the effect of the bispecific targeting agent as a therapeutic or to exert a specific biologic effect on one or both cells being targeted.
摘要翻译：本发明涉及使用脂质体或纳米颗粒作为连接体的新型双特异性靶向剂的平台。双特异性靶向剂可以通过单独的靶向部分结合两种不同的细胞类型。所述靶向剂可以用于在细胞中诱导特定的生物效应，例如细胞增殖或细胞活化，其可以在一些情况下用于破坏其他结合的细胞。任何可以定位的细胞都可以定位。例如，双特异性靶向剂可能募集的细胞类型既可以是人类，也可以是其中一种细胞可以是人类，另一种是感染的细胞，或者它可以是感染因子。该平台基于与两个或更多个靶向部分缀合的空纳米颗粒或脂质体，其以限定的比率结合至纳米颗粒/脂质体，所述限定的比例可以不是1：1。这样的组合物提供了对每种细胞类型的特异性结合。该双特异性靶向剂可以进一步与生长因子或细胞因子连接，以进一步增强双特异性靶向剂作为治疗剂的作用或对被靶向的一种或两种细胞施加特定的生物学作用。

6. 发明申请

WO2013067322A1 METHOD FOR DETERMINATION OF PHARMACOLOGICAL PROPERTIES OF RECOMBINANT PROTEINS 审中-公开
标题翻译：确定重组蛋白质药理学性质的方法
公开(公告)号：WO2013067322A1
公开(公告)日：2013-05-10
申请号：PCT/US2012/063279
申请日：2012-11-02
申请人： STC BIOLOGICS, INC.
发明人： LESZCZYNIECKA, Magdalena
IPC分类号： G01N33/68 , G01N33/53 , A61K38/00
CPC分类号： G01N33/557 , G01N33/68 , G01N2440/00 , G01N2500/04
摘要： The present invention is directed to a method for obtaining an in vitro pharmacological model of a recombinant protein drug in a given host. A plurality of biomolecules are selected which are known or suspected to influence pharmacology of the recombinant protein in the host via a binding interaction with the recombinant protein. The recombinant protein is contacted with each selected biomolecule and the binding kinetics parameters for each interaction are determined using a binding assay. These steps are then repeated with all selected biomolecules to produce a plurality of binding kinetics parameters for the selected biomolecules. The combined results provide an in vitro pharmacological model of the recombinant protein in the host. The in vitro pharmacological model may then be used in several applications, such as optimizing new batches of recombinant protein drugs, developing biosimilar or bio- better drug candidates.
摘要翻译：本发明涉及在给定的宿主中获得重组蛋白质药物的体外药理学模型的方法。选择已知或怀疑通过与重组蛋白的结合相互作用影响宿主中重组蛋白质的药理学的多种生物分子。将重组蛋白与每个选择的生物分子接触，并使用结合测定法确定每个相互作用的结合动力学参数。然后用所有选择的生物分子重复这些步骤以产生所选择的生物分子的多个结合动力学参数。组合的结果提供了宿主中重组蛋白的体外药理学模型。然后可以在多种应用中使用体外药理学模型，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候选药物。

7. 发明专利

CA2954066A1 A METHOD FOR DEVELOPMENT OF RECOMBINANT PROTEINS WITH FINGERPRINT LIKE SIMILARITY TO THE REFERENCE PRODUCT 未知
公开(公告)号：CA2954066A1
公开(公告)日：2016-01-07
申请号：CA2954066
申请日：2015-07-01
申请人： STC BIOLOGICS INC
发明人： LESZCZYNIECKA MAGDALENA , SHAHROKH ZAHRA
IPC分类号： C12P21/00 , G01N27/62 , G01N33/68
摘要： The present invention relates to the methods of developing recombinant proteins with a fingerprint like similarity to the reference product or the originator. The method is particularly useful in the development of biosimilar products. This method can also be used to establish comparability during the manufacturing process change for the originator products. Hie methods described herein are used to obtain a recipe for the production of a biosimilar product or a recombinant protein using a process that may be different from the original but that yields a recombinant protein that has fingerprint level of similarity to the reference product. The methods described herein can also used to obtain a fingerprinting analysis package for a biosimilar that can be submitted to regulatory agency for abbreviated biosimilar approval. While currently available analytical methods can identify and quantitate specific modifications on a recombinant, protein, no methods currently exist to measure and determine the concentration of product variants in a complex: mixture. The analytical methods described herein provide for identification and quantitation of the modifications of the recombinant proteins and of product variants in a complex mixture by utilizing various in silico computational approaches to transform analytical data and derive product variant distribution.

8. 发明专利

IL249880D0 A method for development of recombinant proteins with fingerprint like similarity to the reference product 未知
公开(公告)号：IL249880D0
公开(公告)日：2017-03-30
申请号：IL24988017
申请日：2017-01-01
申请人： STC BIOLOGICS INC
IPC分类号： C12P20060101

9. 发明公开

EP2773964A1 METHOD FOR DETERMINATION OF PHARMACOLOGICAL PROPERTIES OF RECOMBINANT PROTEINS 审中-公开
标题翻译：方法用于确定的药理学性质的重组蛋白
公开(公告)号：EP2773964A1
公开(公告)日：2014-09-10
申请号：EP12844950.1
申请日：2012-11-02
申请人： STC Biologics, Inc.
发明人： LESZCZYNIECKA, Magdalena
IPC分类号： G01N33/68 , G01N33/53 , A61K38/00
CPC分类号： G01N33/557 , G01N33/68 , G01N2440/00 , G01N2500/04
摘要： The present invention is directed to a method for obtaining an in vitro pharmacological model of a recombinant protein drug in a given host. A plurality of biomolecules are selected which are known or suspected to influence pharmacology of the recombinant protein in the host via a binding interaction with the recombinant protein. The recombinant protein is contacted with each selected biomolecule and the binding kinetics parameters for each interaction are determined using a binding assay. These steps are then repeated with all selected biomolecules to produce a plurality of binding kinetics parameters for the selected biomolecules. The combined results provide an in vitro pharmacological model of the recombinant protein in the host. The in vitro pharmacological model may then be used in several applications, such as optimizing new batches of recombinant protein drugs, developing biosimilar or bio- better drug candidates.

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