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公开(公告)号:US09804170B2
公开(公告)日:2017-10-31
申请号:US15018353
申请日:2016-02-08
Applicant: Bristol-Myers Squibb Company
Inventor: Murli Krishna , Alexander T. Kozhich , Martin J. Corbett , Zheng Lin , Steven P. Piccoli
CPC classification number: G01N33/6854 , C07K16/44 , C07K2317/24 , G01N2800/52
Abstract: Polyethylene glycol (PEG) is often conjugated with therapeutic proteins to enhance their PK properties. PEG may, however, be immunogenic, and the presence of PEG in food and cosmetics is believed to result in pre-existing anti-PEG antibodies in humans. Polyclonal and monoclonal antibodies reactive to PEG are provided for use in immunogenicity assay development to detect such anti-drug antibodies. Such antibodies exhibit preferential binding based on the size of PEG with molecular weight ranging from 350 daltons to 40 kD. Anti-PEG antibodies of the invention are engineered to comprise human Fc regions to enable non-bridging immunoassay formats.
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公开(公告)号:US10451634B2
公开(公告)日:2019-10-22
申请号:US15720073
申请日:2017-09-29
Applicant: BRISTOL-MYERS SQUIBB COMPANY
Inventor: Murli Krishna , Alexander T. Kozhich , Martin J. Corbett , Zheng Lin , Steven P. Piccoli
Abstract: Polyethylene glycol (PEG) is often conjugated with therapeutic proteins to enhance their PK properties. PEG may, however, be immunogenic, and the presence of PEG in food and cosmetics is believed to result in pre-existing anti-PEG antibodies in humans. Polyclonal and monoclonal antibodies reactive to PEG are provided for use in immunogenicity assay development to detect such anti-drug antibodies. Such antibodies exhibit preferential binding based on the size of PEG with molecular weight ranging from 350 daltons to 40 kD. Anti-PEG antibodies of the invention are engineered to comprise human Fc regions to enable non-bridging immunoassay formats.
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公开(公告)号:US20180038872A1
公开(公告)日:2018-02-08
申请号:US15720073
申请日:2017-09-29
Applicant: BRISTOL-MYERS SQUIBB COMPANY
Inventor: Murli Krishna , Alexander T. Kozhich , Martin J. Corbett , Zheng Lin , Steven P. Piccoli
CPC classification number: G01N33/6854 , C07K16/44 , C07K2317/24 , C07K2317/33 , C07K2317/92 , G01N2800/52
Abstract: Polyethylene glycol (PEG) is often conjugated with therapeutic proteins to enhance their PK properties. PEG may, however, be immunogenic, and the presence of PEG in food and cosmetics is believed to result in pre-existing anti-PEG antibodies in humans. Polyclonal and monoclonal antibodies reactive to PEG are provided for use in immunogenicity assay development to detect such anti-drug antibodies. Such antibodies exhibit preferential binding based on the size of PEG with molecular weight ranging from 350 daltons to 40 kD. Anti-PEG antibodies of the invention are engineered to comprise human Fc regions to enable non-bridging immunoassay formats.
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公开(公告)号:US20180088111A1
公开(公告)日:2018-03-29
申请号:US15565525
申请日:2016-04-12
Applicant: BRISTOL-MYERS SQUIBB COMPANY
Inventor: Yan G. Ni , Xiling Yuan , Steven P. Piccoli
IPC: G01N33/566 , G01N33/74
CPC classification number: G01N33/566 , G01N33/74
Abstract: This disclosure provides a method for quantifying total soluble Programmed Death-1 (sPD-1) in a sample solution comprising the steps of performing a “sandwich” immunoassay on the sample solution and a series of reference solutions containing known quantities of sPD-1, wherein the immunoassay is performed using (a) a sPD-1 reference antigen in monomeric form; (b) a capture antibody that is capable of binding to sPD-1 in both monomeric and dimeric forms, which binding is essentially unaffected by the presence of the PD-1 ligands, PDL-1, PDL-2, and/or a therapeutic anti-PD-1 antibody; and (c) an electrochemiluminescent-labeled detection antibody that is capable of binding to sPD-1 in both monomeric and dimeric forms, which binding is to a different epitope on sPD-1 than the epitope bound by the capture Ab and is essentially unaffected by the presence of PDL-1, PDL-2 and/or a therapeutic anti-PD-1 Ab.
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5.
公开(公告)号:US20160231328A1
公开(公告)日:2016-08-11
申请号:US15018353
申请日:2016-02-08
Applicant: Bristol-Myers Squibb Company
Inventor: Murli KRISHNA , Alexander T. Kozhich , Martin J. Corbett , Zheng Lin , Steven P. Piccoli
CPC classification number: G01N33/6854 , C07K16/44 , C07K2317/24 , G01N2800/52
Abstract: Polyethylene glycol (PEG) is often conjugated with therapeutic proteins to enhance their PK properties. PEG may, however, be immunogenic, and the presence of PEG in food and cosmetics is believed to result in pre-existing anti-PEG antibodies in humans. Polyclonal and monoclonal antibodies reactive to PEG are provided for use in immunogenicity assay development to detect such anti-drug antibodies. Such antibodies exhibit preferential binding based on the size of PEG with molecular weight ranging from 350 daltons to 40 kD. Anti-PEG antibodies of the invention are engineered to comprise human Fc regions to enable non-bridging immunoassay formats.
Abstract translation: 聚乙二醇(PEG)通常与治疗性蛋白质结合以增强其PK性质。 然而,PEG可能是免疫原性的,并且据信PEG在食品和化妆品中的存在导致人中预先存在的抗-PEG抗体。 提供与PEG反应的多克隆和单克隆抗体用于免疫原性测定开发以检测此类抗药物抗体。 此类抗体基于分子量范围为350道尔顿至40kD的PEG的大小显示优先结合。 将本发明的抗-PEG抗体工程改造成包含人Fc区域以实现非桥接免疫测定形式。
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