Abstract: The present invention provides combination therapy that includes an KRASG12C inhibitor, such as or a pharmaceutically acceptable salt thereof, and one or more additional pharmaceutically active agents, particularly for the treatment of cancers. The invention also relates to pharmaceutical compositions that contain an KRASG12C inhibitor and one or more additional pharmaceutically active agents for the treatment of cancers.

Abstract: Methods of preventing the formation of lamellar silica formation in a borosilicate glass container storing a pharmaceutical formulation in an interior of the glass container in accordance with embodiments of the disclosure can include washing the container and drying the container under extended dry conditions of at least 3000 ms.

Abstract: Delivery devices for administering drugs are disclosed. An example apparatus, includes a body including: a handle in which a syringe assembly is to be disposed; a base having a bottom face to be disposed adjacent a user; and an absorbent material attached to the bottom face, the absorbent material structured to hold a fluid to be released onto the user prior to or during an injection procedure.

Abstract: Drug delivery devices are described that include an escapement activation assembly. The escapement activation assembly includes a slide having a plurality of pallet engagement portions and a switch engagement portion and a pallet having a plurality of slide engagement portions. A drive is coupled to the pallet to cause the pallet to move relative to the slide to move the plurality of slide engagement portions into and out of engagement with the plurality of pallet engagement portions to allow the slide to move along a path within the drug delivery device. Movement of the slide can cause the switch engagement portion to move out of engagement with an activation trigger of a mechanism of the drug delivery device.

Abstract: An injector includes a housing having a syringe assembly and an actuating mechanism at least partially disposed within the housing. The syringe assembly includes a syringe barrel that stores a medicament to be injected into a user, a needle assembly, and a filter member disposed adjacent to the needle assembly. The actuating mechanism is operatively coupled to the syringe assembly and includes a torque spring that exerts a torque to urge the medicament through the filter member to be injected into the user. The actuating mechanism further includes a damper mechanism that exerts an opposing force to dampen the motion exerted by the torque spring.

Abstract: An injection device, method, and system for drug delivery includes a primary container for storing a drug, the container having a stopper movably disposed in the container for expelling the drug, an injection drive mechanism comprising a plunger for acting on the stopper and an energy source for exerting a force on the plunger to cause the plunger to act on the stopper to expel the drug, the force causing the plunger to accelerate to a velocity prior to acting on the stopper, and a damping mechanism for reducing the velocity of the plunger prior to acting on the stopper. The damping mechanism can include a dashpot or an energy absorbing material associated with the plunger. Alternatively or additionally, the damping mechanisms can include absorbing material disposed between support members of an outer casing of the injection device and the primary container.

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.

Abstract: Systems and methods that facilitate the automatic (or substantially automatic) preparation of a sample of a product containing polypeptides for glycan analysis and automatic (or substantially automatic) performance of a glycan assay of that sample. Thus, the preparation and analysis can be performed substantially in-real time, or, in other words, much more quickly than presently allowed by conventional systems and methods.

Abstract: The present invention relates to methods for reducing low molecular weight species of recombinantly-produced proteins. In particular, methods of reducing the formation of low molecular weight species produced by a host cell during the cell culture process through pH control of the production cell culture are disclosed. Also disclosed are methods for reducing or eliminating the generation of alternative splice variants by a host cell during production of a recombinant protein.

Abstract: Compounds of formula (A) are provided which are useful in the treatment of diseases or conditions modulated at least in part by CCR6:

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: Methods of manufacturing a biological therapy are described. The methods can comprise detecting a level of a molecular attribute of the biological therapy in a formulation, determining a rate of change of the molecular attribute under the storage conditions, and estimating a level of molecular attribute exposure received by the subjects at the time of said administration. Production lots of the biological therapy comprising the molecular attribute can be manufactured comprising the molecular attribute at or below a specified specification for permissible levels of the molecular attribute based on the estimated level of molecule attribute exposure. Methods of developing a manufacturing process for a biological therapy are described. Methods of assessing the clinical impact of a molecular attribute of a biological therapy are described.

Abstract: Antigen binding proteins that bind to human IL-23 protein are provided. Nucleic acids encoding the antigen binding protein, vectors, and cells encoding the same as well as use of IL-23 antigen binding proteins for diagnostic and therapeutic purposes are also provided.

Abstract: Antigen binding molecules, chimeric receptors, and engineered immune cells to DLL3 are disclosed in accordance with the invention. The invention further relates to vectors, compositions, and methods of treatment and/or detection using the DLL3 antigen binding molecules and engineered immune cells.

Abstract: The clinical potential of multispecific antibodies like bispecific and trispecific antibodies shows great promise for targeting complex diseases. However, the generation of those molecules presents great challenges particularly in regard to achieving acceptable expression levels free from mis-paired polypeptides. The presently claimed invention is directed to multispecific antigen binding proteins which improve upon existing charge pair technologies by redistributing the engineered charges within the CH3 regions of a heteromultimer.

Abstract: Disclosed are methods of determining the suitability of a variable-length spectrophotometer using Patent Blue dye or AMG Blue dye. Also disclosed herein are methods of determining the suitability of a fixed path length spectrophotometer for determining protein concentration of a protein sample. AMG Blue dye may also be used to determine the suitability of fixed path length spectrophotometers.

Abstract: Disclosed herein is a method of conducting direct detection 1H solid state NMR (“ssNMR”) on a macromolecule-containing solid state formulation. The method includes conducting a 1H spin-lattice relaxation time (“T1”) experiment on the solid state formulation at various temperatures to generate a T1 value at each temperature, converting the T1 values to 1H spin-lattice relaxation rate (“R1”), and plotting R1 versus temperature to generate a relaxation rate curve for the solid state formulation. The relaxation rate curve can be analyzed to determine the molecular mobility of the macromolecule in the solid state formulation, the degree of aggregation in the solid state formulation, and/or the stability of the solid state formulation.

Abstract: The present invention relates to the field of biopharmaceutical manufacturing. In particular, the invention relates to using temperature as a lever to modulate product quality during upstream operations.