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公开(公告)号：US11813328B2
公开(公告)日：2023-11-14
申请号：US15521057
申请日：2015-10-22
Applicant: AMGEN INC.
Inventor： Christopher James Sloey , Sekhar Kanapuram
IPC: A61K39/395 , A61K47/18 , A61K9/19 , A61K9/00
CPC classification number: A61K39/39591 , A61K9/19 , A61K39/3955 , A61K47/183 , A61K9/0019 , C07K2317/90
Abstract: A method for reducing the viscosity of a pharmaceutical formulation is provided that utilizes a viscosity-reducing concentration of an excipient selected from the group consisting of the n-acetyl arginine, n-acetyl lysine, n-acetyl proline and mixtures thereof in combination with a therapeutiv protein. A stable pharmaceutical formulation is also provided.
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公开(公告)号：US11918650B2
公开(公告)日：2024-03-05
申请号：US15972489
申请日：2018-05-07
Applicant: AMGEN INC.
Inventor： Jeff Abel , Lingwen Cui , Devrishi Goswami , Joon Huh , Bharadwaj Jagannathan , Sekhar Kanapuram , Arnold McAuley , Michael Schneider , Ananthakrishnan G. Sethuraman , Michael Treuheit , Jun Zhang
IPC: A61K39/395 , A61K9/00 , A61K9/08 , A61K9/19 , A61K47/10 , A61K47/12 , A61K47/14 , A61K47/18 , A61K47/24 , A61K47/26 , C07K16/28 , C07K16/46 , A61J1/05 , A61J1/10 , A61K39/00
CPC classification number: A61K39/39591 , A61K9/0019 , A61K9/08 , A61K9/19 , A61K39/3955 , A61K47/10 , A61K47/12 , A61K47/14 , A61K47/183 , A61K47/24 , A61K47/26 , C07K16/2803 , C07K16/2809 , C07K16/2863 , C07K16/468 , A61J1/05 , A61J1/10 , A61K2039/54 , A61K2039/545 , A61K2039/627 , C07K2317/24 , C07K2317/31 , C07K2317/41 , C07K2317/569
Abstract: The present invention provides an improved pharmaceutical composition for storage and administration comprising (a) a bispecific antibody construct comprising a first domain binding to a target cell surface antigen and a second domain binding to a second antigen, wherein the bispecific antibody construct is present at a concentration in the range from about 0.5 μg/ml to 20 mg/ml, (b) a preservative at a concentration effective to inhibit the growth of microbes, and (c) a diluent wherein bispecific antibody construct is stable and recoverable.
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公开(公告)号：US11464857B2
公开(公告)日：2022-10-11
申请号：US15902775
申请日：2018-02-22
Applicant: AMGEN INC.
Inventor： Christopher James Sloey , Sekhar Kanapuram , Huanchun Cui , Chio Mui Chan , Elaheh Binabaji
Abstract: Provided herein are formulations of PCSK9-binding polypeptides, such as those comprising evolocumab, that comprise N-acetyl arginine and have reduced viscosities when compared to formulations lacking N-acetyl arginine. Provided herein are also methods of formulating such compositions that are advantageous in that they conserve certain components. Such formulations comprising PCSK9-binding polypeptides can be administered to patients to treat and/or prevent PCSK9-related diseases, conditions, and disorders.
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公开(公告)号：US11419933B2
公开(公告)日：2022-08-23
申请号：US15414723
申请日：2017-01-25
Applicant: AMGEN INC. , AMGEN RESEARCH (MUNICH) GMBH
Inventor： Sekhar Kanapuram , Ramil Latypov , Balakumar Thangaraj , Cornelius Pompe
IPC: A61K39/395 , C07K16/28 , A61K9/00 , A61K47/18 , A61K9/16 , A61K9/19 , A61K47/02 , A61K47/10 , A61K47/12 , A61K47/26 , A61K47/40 , B01D61/14 , A61K39/00
Abstract: The present invention provides novel and stable pharmaceutical compositions comprising bispecific single chain antibody constructs, cyclodextrins and a buffer.
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公开(公告)号：US12103979B2
公开(公告)日：2024-10-01
申请号：US16607673
申请日：2018-04-27
Applicant: AMGEN INC.
Inventor： Neeraj Jagdish Agrawal , Pavan Ghattyvenkatakrishna , Sekhar Kanapuram , Christopher James Sloey
IPC: A61K39/395 , A61K9/08 , A61K9/19 , A61K31/198 , A61K31/401 , A61K31/4172 , A61K38/05 , A61K47/18 , A61K47/26 , C07K5/06 , C07K16/18 , C07K16/40
CPC classification number: C07K16/40 , A61K9/08 , A61K9/19 , A61K31/198 , A61K31/401 , A61K31/4172 , A61K38/05 , A61K39/3955 , A61K39/39591 , A61K47/183 , A61K47/26 , C07K5/06 , C07K16/18
Abstract: Provided herein are excipients capable of effectively reducing the viscosity of polypeptide (e.g., therapeutic polypeptide) formulations. The viscosity reducing excipients are dipeptides containing arginine at the carboxy terminus and N-acetylated serine or N-acetylated proline at the N-terminus. Glutamate-arginine is also disclosed as a viscosity-reducing dipeptide. Among the disclosed methods, methods of reducing the viscosities of such formulations are also provided.
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Patent Agency Ranking
公开(公告)号：US20230406929A1
公开(公告)日：2023-12-21
申请号：US18251120
申请日：2021-11-08
Applicant: AMGEN INC. , AMGEN RESEARCH (MUNICH)
Inventor： Doris Rau , Tobias Raum , Partrick Hoffmann , Markus Muenz , Matthias Klinger , Virginie Naegele , Lisa Winkel , Pavan Ghattyvenkatakrishna , Joon Hoi Huh , Arnold McAuley , Sekhar Kanapuram
IPC: C07K16/28
CPC classification number: C07K16/2809 , C07K16/2875 , C07K2317/31 , C07K2317/622 , C07K2317/73 , C07K2317/94 , C07K2317/92
Abstract: The invention relates to a polypeptide or polypeptide construct comprising: a binding domain binding to an extracellular epitope of the human CD3s chain comprising or consisting of a VH region and a VL region, wherein i) the VH region comprises: a CDR-H1 sequence of X1YAX2N, where X1 is K, V, S, G, R, T, or I; and X2 is M or I; a CDR-H2 sequence of RIRSKYNNYATYYADX1VKX2, where X1 is S or Q; and X2 is D, G, K, S, or E; and a CDR-H3 sequence of HX1NFGNSYX2SX3X4AY, where X1 is G, R, or A; X2 is I, L, V, or T; X3 is Y, W or F; and X4 is W, F or Y; and ii) wherein the VL region comprises: a CDR-L1 sequence of X1 SSTGAVTX2X3X4YX5N, where X1 is G, R, or A; X2 is S or T; X3 is G or S; X4 is N or Y and X5 is P or A; a CDR-L2 sequence of X1TX2X3X4X5X6; where X1 is G or A; X2 is K, D, or N; X3 is F, M or K; X4 is L or R; X5 is A, P, or V; and X6 is P or S; and a CDR-L3 sequence of X1LWYSNX2VW, where X1 is V, A, or T; and X2 is R or L; and iii) wherein one or more of CDR sequences of the VH region of i) and/or of the VL region of ii) comprise one amino acid substitution or a combination thereof selected from X24V and X24F in CDR-H1; D15, and X116A in CDR-H2; H1, X12E, F4, and N6 in CDR-H3; and X11L and W3 in CDR-L3. The invention also relates to a polynucleotide encoding the polypeptide or polypeptide construct of the invention, a vector comprising said polynucleotide and a host cell transformed or transfected with said polynucleotide or with said vector. Moreover, the invention also provides for a process for the production of said polypeptide or polypeptide construct and a pharmaceutical composition comprising said polypeptide or polypeptide construct of the invention. Furthermore, the invention relates to medical uses of said polypeptide or polypeptide construct and kits comprising said polypeptide or polypeptide construct.
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公开(公告)号：US20220378908A1
公开(公告)日：2022-12-01
申请号：US17771313
申请日：2020-10-23
Applicant: AMGEN INC.
Inventor： Chen Zhu , Daniel Gerard Greene , Qi Hao , Sekhar Kanapuram , Michael J. Treuheit
IPC: A61K39/395 , A61K47/26 , A61K47/10 , A61J1/14 , A61J1/10
Abstract: The present invention relates to compositions and methods for minimizing protein loss (e.g., due to adsorption to solid surfaces) at low protein concentrations. Inventions disclosed herein generally relate to the field of compositions comprising proteins, in particular, pharmaceutical compositions comprising therapeutic proteins at low protein concentrations. Inventions disclosed herein also relate to methods of administering the composition to a subject in need thereof.
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公开(公告)号：US20200332000A1
公开(公告)日：2020-10-22
申请号：US16482603
申请日：2018-02-02
Applicant: AMGEN RESEARCH (MUNICH) GMBH , AMGEN INC.
Inventor： Arnold Mcauley , Pavan Ghattyvenkatakrishna , Jeff Abel , Joon Huh , Cornelius Pompe , Sekhar Kanapuram , Michael Treuheit , Bharadwaj Jagannathan
Abstract: The present disclosure provides a low pH pharmaceutical composition comprising (a) an antibody constructs comprising a first domain binding to a target cell surface antigen, a second domain binding to a second antigen and preferably a third domain, which is a specific Fc modality, (b) at least one buffer agent, (c) at least one saccharide, and (d) at least one surfactant; and wherein the pH of the pharmaceutical composition is in the range of 3.5 to 6.
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9.发明申请公开(公告)号：US20190151448A1
公开(公告)日：2019-05-23
申请号：US15972489
申请日：2018-05-07
Applicant: AMGEN INC.
Inventor： Jeff Abel , Lingwen Cui , Devrishi Goswami , Joon Huh , Bharadwaj Jagannathan , Sekhar Kanapuram , Arnold McAuley , Michael Schneider , Ananthakrishnan G. Sethuraman , Michael Treuheit , Jun Zhang
IPC: A61K39/395 , C07K16/28 , A61K47/10 , A61K47/14 , A61K47/24 , A61K47/12 , A61K47/26 , A61K47/18 , C07K16/46
Abstract: The present invention provides an improved pharmaceutical composition for storage and administration comprising (a) a bispecific antibody construct comprising a first domain binding to a target cell surface antigen and a second domain binding to a second antigen, wherein the bispecific antibody construct is present at a concentration in the range from about 0.5 μg/ml to 20 mg/ml, (b) a preservative at a concentration effective to inhibit the growth of microbes, and (c) a diluent wherein bispecific antibody construct is stable and recoverable.
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公开(公告)号：US20170209571A1
公开(公告)日：2017-07-27
申请号：US15414723
申请日：2017-01-25
Applicant: AMGEN INC. , AMGEN RESEARCH (MUNICH) GMBH
Inventor： Sekhar Kanapuram , Ramil Latypov , Balakumar Thangaraj , Cornelius Pompe
IPC: A61K39/395 , A61K47/40 , A61K47/10 , B01D61/14 , A61K47/02 , A61K47/26 , A61K9/19 , A61K9/16 , C07K16/28 , A61K47/12
CPC classification number: A61K39/3955 , A61K9/0019 , A61K9/1652 , A61K9/19 , A61K47/02 , A61K47/10 , A61K47/12 , A61K47/183 , A61K47/26 , A61K47/40 , A61K2039/505 , B01D61/145 , B01D2315/16 , C07K16/2803 , C07K16/2809 , C07K16/2878 , C07K2317/24 , C07K2317/31 , C07K2317/622 , C07K2317/94
Abstract: The present invention provides novel and stable pharmaceutical compositions comprising bispecific single chain antibody constructs, cyclodextrins and a buffer.
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