Abstract: Pharmaceutical formulations comprising an antibody that specifically binds to human interleukin-4 receptor alpha (hIL-4R?) are provided. The formulations may contain, in addition to an anti-IL-4R? antibody, one or more buffers, at least one amino acid, at least one sugar, and a surfactant. Methods for producing pharmaceutical formulations with reduced lipase activity are also provided, which may include subjecting a drug substance to agitation stress, heat stress, and additional ion exchange or size exclusion chromatography. In one aspect, the pharmaceutical formulations do not have appreciable subvisible particle formation in the presence of lipase, and exhibit a substantial degree of antibody stability during storage and after being subjected to thermal and other physical stresses.

Abstract: The present inventions relate to improved lyophilization methods for therapeutic proteins, such as monoclonal antibodies, using controlled nucleation. The controlled nucleation approach is time efficient, and produces lyophilized products with high quality and faster reconstitution times. The present inventions also relate to efficient lyophilization process to achieve moderate moisture content in room temperature stable therapeutic proteins.

Abstract: The present disclosure relates to the field of noise reduction technologies, and specifically a motor noise control method and apparatus, a computer device and a storage medium are provided. The method includes: determining a current driving mode of a vehicle and a total torque required by the vehicle in the current driving mode; acquiring an electric drive noise distribution matrix of the vehicle in the current driving mode, where the electric drive noise distribution matrix includes correspondences among target motor noises, target motor speeds, and target motor torques of respective motors in the current driving mode; and distributing a torque of each motor according to the electric drive noise distribution matrix, where a sum of torques of the respective motors is equal to the total torque required by the vehicle.

Abstract: The present disclosure provides a stable protein composition containing a surfactant and having less than 400 subvisible particles of 10 microns or greater diameter per container, or less than 10,000 subvisible particles of 2 microns or greater per container. A method of manufacturing such a stable protein composition is disclosed, which includes a unit of operation that removes or decreases an esterase activity that degrades the surfactant. The unit of operation may be hydrophobic interaction chromatography or filtration, mixed mode chromatography, or the like.

Abstract: Lyophilization methods for preparing protein formulations for long-term storage at room temperature or improved stability at refrigeration storage are provided. Specifically, the present application provides lyophilization methods to obtain a target percentage of residual moisture of a lyophilized product, such as 3-5% residual moisture. The secondary drying of the lyophilization can be conducted under controlling rate of desorption under a temperature which is similar to the shelf temperature of the primary drying. Alternatively, the lyophilization can be conducted without a distinguished secondary drying step.

Abstract: Methods for stabilizing an Fc-containing protein preparation in an aqueous solution are provided herein. The disclosed methods can stabilize the Fc-containing protein in a drug product, especially for liquid formulations, by using phenol or benzyl alcohol as preservatives.

Abstract: The present invention provides pharmaceutical formulations comprising a human antibody that specifically binds to human interleukin-4 receptor (hIL-4R). The formulations may contain, in addition to an anti-hIL-4R antibody, at least one amino acid, at least one sugar, or at least one non-ionic surfactant. The pharmaceutical formulations of the present invention exhibit a substantial degree of antibody stability after storage for several months.

Abstract: The present inventions relate to methods of preparing highly concentrated monoclonal antibody (mAb) formulations, including screening and selection of excipients to include in mAb formulation. Excipients include amino acids, salts and polyols.

Abstract: The present disclosure provides pharmaceutical formulations comprising one or more antibodies or antigen-binding fragments thereof that bind to the cat allergen Fel d1. The formulations may contain, in addition to the anti-Fel d1 antibody, a buffer, a thermal stabilizer, a viscosity reducer, and a surfactant. In one aspect, co-formulations comprising two anti-Fel d1 antibodies are provided that have acceptable stability and optimal viscosity.

Abstract: Biopharmaceutical compositions and drug products disclosed herein exhibit reduced amounts of subvisible particle formation. Compositions and drug products disclosed herein comprise a protein and a surfactant or stabilizer including high percentage amounts of a long-chain fatty acid ester. Also disclosed herein are methods of preparing and storing such compositions and drug products.

Abstract: The present disclosure provides a stable protein composition containing a surfactant and having less than 400 subvisible particles of 10 microns or greater diameter per container, or less than 10,000 subvisible particles of 2 microns or greater per container. A method of manufacturing such a stable protein composition is disclosed, which includes a unit of operation that removes or decreases an esterase activity that degrades the surfactant. The unit of operation may be hydrophobic interaction chromatography or filtration, mixed mode chromatography, or the like.

Abstract: Lyophilization methods for preparing protein formulations for long-term storage at room temperature or improved stability at refrigeration storage are provided. Specifically, the present application provides lyophilization methods to obtain a target percentage of residual moisture of a lyophilized product, such as 3-5% residual moisture. The secondary drying of the lyophilization can be conducted under controlling rate of desorption under a temperature which is similar to the shelf temperature of the primary drying. Alternatively, the lyophilization can be conducted without a distinguished secondary drying step.

Abstract: Biopharmaceutical compositions and drug products disclosed herein exhibit reduced amounts of subvisible particle formation. Compositions and drug products disclosed herein comprise a protein and a surfactant or stabilizer including high percentage amounts (e.g., at least 97%) of a long-chain fatty acid ester. Also disclosed herein are methods of preparing and storing such compositions and drug products.

Abstract: Pharmaceutical formulations comprising an antibody that specifically binds to human interleukin-4 receptor alpha (hIL-4R?) are provided. The formulations may contain, in addition to an anti-IL-4R? antibody, one or more buffers, at least one amino acid, at least one sugar, and a surfactant comprising a polysorbate, polyethylene glycol or a poloxamer. Methods for producing pharmaceutical formulations with reduced lipase activity are also provided, which may include subjecting a drug substance to anion exchange chromatography in acidic conditions, agitation stress, heat stress, and additional ion exchange or size exclusion chromatography. In one aspect, the pharmaceutical formulations do not have appreciable subvisible particle formation in the presence of lipase, and exhibit a substantial degree of antibody stability during storage and after being subjected to thermal and other physical stresses.

Abstract: The present disclosure provides a co-formulation that includes an antibody that binds specifically to C5 and a C5 iRNA which is a glycoconjugate that includes a ligand having terminal N-Acetylgalactosamine (GalNAc) residues and/or N-acetylglucosamine (GlcNAc) residues. Methods for reducing degradation of glycoconjugate RNA by beta-hexosaminidase enzyme are also provided. The present disclosure also includes methods for treating or preventing a C5-associated disease or disorder by administering one or more doses of an anti-C5 antibody or antigen-binding fragment thereof in combination with one or more doses of a C5 iRNA; preferably wherein the anti-C5 antibody or fragment and the C5 iRNA are in a co-formulation. The present disclosure also includes dosing regimens for treating C5-associated disease or disorder with a combination of anti-C5 antibody and C5 iRNA in subjects that either are treatment naïve or are switching from a previous C5 inhibitor therapy.

Abstract: The present invention relates to a platform door control apparatus based on a double 2-vote-2 architecture, including a security communication and logic processing module, a driver collection module, and a maintenance module, the security communication and logic processing module is separately connected to the driver collection module and the maintenance module, and both the security communication and logic processing module and the driver collection module are devices using the double 2-vote-2 architecture. Compared with the prior art, the present invention has the following advantages of effectively improving linkage efficiency of a signal system and a platform door system, and the like.

Abstract: The present invention provides pharmaceutical formulations comprising a human antibody that specifically binds to human interleukin-4 receptor (hIL-4R). The formulations may contain, in addition to an anti-hIL-4R antibody, at least one amino acid, at least one sugar, or at least one non-ionic surfactant. The pharmaceutical formulations of the present invention exhibit a substantial degree of antibody stability after storage for several months.

Abstract: Pharmaceutical formulations comprising an antibody that specifically binds to human interleukin-4 receptor alpha (hIL-4R?) are provided. The formulations may contain, in addition to an anti-IL-4R? antibody, one or more buffers, at least one amino acid, at least one sugar, and a surfactant comprising a polyethylene glycol or a poloxamer. In one aspect, the pharmaceutical formulations do not have appreciable subvisible particle formation in the presence of lipase, and exhibit a substantial degree of antibody stability during storage and after being subjected to thermal and other physical stresses.

Abstract: The present invention pertains to methods for manufacturing high titer antibody products. In particular, the invention pertains, in part, to improved serum-free animal cell culture medium, which can used for the production of a protein of interest. Additionally, the present invention further pertains to chromatographic procedures employed to successfully isolate the antibody product subject of the present disclosure.

Abstract: Lyophilization methods for preparing protein formulations for long-term storage at room temperature or improved stability at refrigeration storage are provided. Specifically, the present application provides lyophilization methods to obtain a target percentage of residual moisture of a lyophilized product, such as 3-5% residual moisture. The secondary drying of the lyophilization can be conducted under controlling rate of desorption under a temperature which is similar to the shelf temperature of the primary drying. Alternatively, the lyophilization can be conducted without a distinguished secondary drying step.