Abstract: Provided herein are methods of assessing or validating a cleaning procedure of a biotherapeutic manufacturing process, said method comprising analyzing by a surface plasmon resonance (SPR)-based assay the binding activity of a cleaned sample to a ligand which binds to a biotherapeutic produced by the manufacturing process. In various embodiments, the cleaning procedure comprises one or more steps to inactivate and/or degrade the biotherapeutic. In various instances, the method demonstrates that greater than about 99.99% degradation of the therapeutic is achieved by the cleaning procedure comprising the one or more steps to inactivate and/or degrade the biotherapeutic.
Abstract: A drug delivery system is disclosed that includes a drug delivery device having a reservoir and a delivery cannula having a proximal end in fluid communication with the reservoir and a distal end to be received within a patient. The drug delivery system may further include one or more sensors coupled to the drug delivery device, a wireless transmitter, and a controller coupled to the one or more sensors and the wireless transmitter. The controller may be configured to use the one or more sensors to determine a condition or an operational state of the drug delivery device, and control the wireless transmitter to wirelessly transmit one or more reports representative of the condition or the operational state of the drug delivery device. A method for use with a drug delivery device is also disclosed.
Type:
Grant
Filed:
May 13, 2020
Date of Patent:
August 29, 2023
Assignee:
AMGEN INC.
Inventors:
Adam B. McCullough, Ferry Tamtoro, Huaying Yang, Mark Ka Lai Lee, Desheng Yin, Scott R. Gibson, Donald Busby, Peter V. Shultz, Keith P. Kogler, Jimmie L. Ward, Christopher R. Folk, Steven William Badelt
Abstract: An insertion mechanism for a drug pump includes an insertion mechanism housing; a sleeve; a rotational biasing member initially held in an energized state; a retraction biasing member and a hub connected to a proximal end of a needle, wherein the retraction biasing member is held initially in an energized state between the hub and the sleeve. The needle is inserted into a target tissue by the rotational biasing member and interaction between the hub and housing. Retraction of the needle is caused by decompressing or de-energizing of the retraction biasing member. A drug delivery pump includes an activation mechanism, a drive mechanism, a sterile access connection, and the insertion mechanism. Assembly and operation methods are provided.
Type:
Grant
Filed:
March 16, 2020
Date of Patent:
August 29, 2023
Assignee:
AMGEN INC.
Inventors:
Mark A. Destefano, Lawton Laurence, John C. Love, Ian B. Hanson, Paul F. Bente, IV
Abstract: GDF15 polypeptides, constructs comprising GDF15, and mutants thereof are provided. In various embodiments the GDF15 polypeptides, constructs comprising GDF15, and mutants thereof, can be of use in the treatment or ameliorating a metabolic disorder. In various embodiments the metabolic disease or disorder is type 2 diabetes, obesity, dyslipidemia, elevated glucose levels, elevated insulin levels and diabetic nephropathy.
Type:
Grant
Filed:
May 17, 2019
Date of Patent:
August 29, 2023
Assignee:
AMGEN INC.
Inventors:
Yumei Xiong, Yi Zhang, Jackie Z. Sheng, Agnes Eva Hamburger, Murielle M. Veniant-Ellison, Grant Shimamoto, Xiaoshan Min, Zhulun Wang, Jie Tang, Gunasekaran Kannan, Kenneth W. Walker, Bryan Lemon
Abstract: Methods and systems of performing an assay. A system for performing an assay includes an enclosure defining a temperature-controlled space. An imaging system, an actuator and a dispenser are disposed within the space. The actuator receives a well plate having wells. The actuator is to move the well plate relative to the imaging system to enable the imaging system to obtain image data of one of the wells. The dispenser includes a pump, an outlet and a reservoir holder to receive a reservoir containing a compound. The pump is to be fluidly coupled to the reservoir and an outlet. The pump is to pump the compound from the reservoir through the outlet into one of the wells. The system also includes a controller. The controller is to cause the dispenser to dispense the compound into the first one of the wells while the imaging system obtains the image data.
Type:
Grant
Filed:
January 14, 2020
Date of Patent:
August 22, 2023
Assignee:
AMGEN INC.
Inventors:
Brandon Zachary Sarich, Michael R. Berke, Chuck Z. Li, Thomas Clark Pearson
Abstract: The present invention relates to RNAi constructs for reducing expression of the ASGR1 gene. Methods of using such RNAi constructs to treat or prevent cardiovascular disease, such as coronary artery disease and myocardial infarction, and to reduce serum non-HDL cholesterol levels are also described.
Type:
Grant
Filed:
October 26, 2020
Date of Patent:
August 22, 2023
Assignee:
AMGEN INC.
Inventors:
Michael Ollmann, Yang Li, Jun Zhang, Oliver Homann, Leslie P. Miranda, Justin K. Murray, Bin Wu, Oh Kyu Yoon, John Gordon Allen, Chawita Netirojjanakul, Yuan Cheng
Abstract: The present invention relates to methods of upregulating the high mannose glycoform content of a recombinant protein during a mammalian cell culture by manipulating the mannose to total hexose ratio in the cell culture media formulation.
Abstract: The present disclosure provides compounds of Formula I, useful for the activation of Triggering Receptor Expressed on Myeloid Cells 2 (“TREM2”). This disclosure also provides pharmaceutical compositions comprising the compounds, uses of the compounds, and compositions for treatment of, for example, a neurodegenerative disorder. Further, the disclosure provides intermediates useful in the synthesis of compounds of Formula I.
Type:
Grant
Filed:
November 30, 2022
Date of Patent:
August 8, 2023
Assignees:
AMGEN INC., Vigil Neuroscience, Inc.
Inventors:
Lara C. Czabaniuk, Timothy Hopper, Jonathan B. Houze, Gwenaella Rescourio, Vincent Santora, Haoxuan Wang, Ryan D. White, Alice R. Wong, Yongwei Wu
Abstract: The present invention relates to variant Fc-containing molecules, such as antibodies and Fc-fusion molecules, having glycosylation characteristics favorable to large-scale production of therapeutic molecules containing such variant Fc.
Type:
Application
Filed:
July 14, 2022
Publication date:
July 27, 2023
Applicant:
Amgen Inc.
Inventors:
Zhimei DU, Pranhitha REDDY, Randal B. BASS, Feng HE, William C. FANSLOW, III, Yuling ZHANG, Da REN, Randall R. KETCHEM
Abstract: The present invention provides a compound of Formula (I): (I); an enantiomer, diastereoisomer, atropisomer thereof, a mixture thereof, or a pharmaceutically acceptable salt thereof, that inhibits voltage-gated sodium channels, in particular NaV1.7. The compounds are useful for the treatment of diseases associated with the activity of sodium channels such as pain disorders, cough, and itch. Also provided are pharmaceutical compositions containing the compounds of the present invention. Also further provided is an atropi-selective preparation of said compounds of Formula (I), and intermediate thereof.
Type:
Application
Filed:
June 10, 2021
Publication date:
July 27, 2023
Applicant:
AMGEN INC.
Inventors:
BENJAMIN C. MILGRAM, ISSAC E. MARX, JOHN STELLWAGEN, WEI ZHAO, ALAN H. CHERNEY
Abstract: The invention provides a method for culturing mammalian cells. The method provides greater control over cell o growth to achieve high product titer cell cultures.
Type:
Application
Filed:
March 8, 2023
Publication date:
July 20, 2023
Applicant:
AMGEN INC.
Inventors:
Brian D. FOLLSTAD, Rebecca E. McCOY, Arvia E. MORRIS
Abstract: The present invention provides heteroalkyl dihydroquinoline sulfonamide compounds of Formula I, and pharmaceutically acceptable salts thereof, that are inhibitors of voltage-gated sodium channels, in particular Nav1.7. The compounds are useful for the treatment of diseases associated with the activity of sodium channels such as pain disorders, cough, and itch. Also provided are pharmaceutical compositions containing compounds of the present invention.
Type:
Application
Filed:
June 11, 2021
Publication date:
July 20, 2023
Applicant:
AMGEN INC.
Inventors:
BENJAMIN C. MILGRAM, GWENAELLA RESCOURIO
Abstract: Provided herein are synthetic methods for the preparation of intermediates that are utilized in the synthesis of omecamtiv mecarbil dihydrochloride.
Type:
Grant
Filed:
March 9, 2022
Date of Patent:
July 18, 2023
Assignee:
Amgen Inc.
Inventors:
Sebastien Caille, James Murray, Kyle Quasdorf, Hannah Nguyen, Maria Victoria Silva Elipe, Ari Elizabeth Ericson
Abstract: The present disclosure provides a method of treating cardiometabolic syndrome (CMS) with a GDF15 molecule. Also provided herein is a method of treating a cardiac or heart condition. In some embodiments, the GDF15 molecule is a GDF15-Fc fusion, in which a GDF15 region is fused to an Fc region, optionally via a linker.
Type:
Application
Filed:
October 2, 2020
Publication date:
July 6, 2023
Applicant:
AMGEN INC.
Inventors:
Murielle Marie V. ELLISON, Clarence H. HALE, Xin LUO, Marina STOLINA
Abstract: The present invention relates to an antibody construct comprising a domain which binds to Claudin 18.2 (CLDN18.2) and another domain which binds to CD3. Moreover, the invention provides a polynucleotide encoding the antibody construct, a vector comprising said polynucleotide and a host cell transformed or transfected with said polynucleotide or vector. Furthermore, the invention provides a process for producing the antibody construct of the invention, a medical use of said antibody construct and a kit comprising said antibody construct.
Type:
Grant
Filed:
August 2, 2019
Date of Patent:
July 4, 2023
Assignees:
AMGEN RESEARCH (MUNICH) GMBH, AMGEN INC.
Inventors:
Christoph Dahlhoff, Claudia Blümel, Johannes Brozy, Tobias Raum, Elisabeth Nahrwold, Tara Arvedson, Irwin Chen, Sandra Ross, Julie Bailis
Abstract: The present invention relates to methods of treating ovarian cancer in a subject by administering to the subject by evaluating the subject's expression levels of specific biomarkers or angiogenic an anti-activin-A compound, such as an anti-activin-A antibody or an activin-A-binding receptor. In some embodiments, at least two compounds are administered to the subject, where the first compound is an anti-activin A compound, and the second compound is a chemotherapeutic compound, for example capecitabine. The invention further relates to methods of identifying subjects for treatment factors.
Type:
Application
Filed:
December 22, 2022
Publication date:
June 29, 2023
Applicants:
AMGEN INC., Atara Biotherapeutics, Inc.
Inventors:
Huiquan HAN, Christopher Michael HAQQ, Isaac CIECHANOVER, Xiaolan ZHOU, John Zhao-Nian LU
Abstract: The invention provides a method for culturing mammalian cells. The method provides greater control over cell growth to achieve high product titer cell cultures.
Type:
Grant
Filed:
December 14, 2022
Date of Patent:
June 27, 2023
Assignee:
AMGEN INC.
Inventors:
Brian D. Follstad, Rebecca E. McCoy, Arvia E. Morris
Abstract: Provided herein are compounds that are useful intermediates that may used to synthesize myeloid cell leukemia 1 protein (Mcl-1) inhibitors. Also provided are Mcl-1 inhibitors, methods of their preparation, related pharmaceutical compositions, and methods of using the same. For example, provided herein are compounds of Formula I, and pharmaceutically acceptable salts thereof and pharmaceutical compositions containing the compounds. The compounds and compositions provided herein may be used, for example, in the treatment of diseases or conditions, such as cancer.