Abstract: The invention provides methods and materials for culturing mammalian cells and harvesting recombinant protein.

Abstract: A drug delivery system includes a reservoir and a drug delivery device coupled to the reservoir. The drug delivery device also may include at least one temperature-sensitive component and a lock having locked and unlocked states. The system further includes an output device, and a controller coupled to the lock and the output device. The controller may also include a temperature sensor, or may be coupled to the temperature sensor. The controller is programmed or configured to determine if the temperature of a drug in the reservoir or of the temperature-sensitive component exceeds an upper limit or is below a lower limit, and to activate the lock in either event. The controller is also programmed or configured to determine, directly or indirectly, if the temperature subsequently is between the upper and lower limits, and to unlock lock as a consequence.

Abstract: The present invention relates to methods of modulating the mannose content of recombinant proteins.

Abstract: The present invention concerns antigen binding proteins that bind TL1A, including bispecific antigen binding proteins (e.g., antibodies) to TL1A and TNF-?. Such bispecific antibodies can be in a tetrameric immunoglobulin format, in which one heavy chain-light chain pair of the antibody is directed to TL1A and the other to TNF-?. The bispecific antigen binding proteins may also be comprised in an IgG-scFv fusion, in which a conventional tetrameric antibody directed to one antigen is fused to a pair of single chain Fv units directed to the other. The bispecific antigen binding protein may also be comprised in an IgG-Fab fusion, in which a Fab molecule that binds to one antigen is fused to each heavy chain of a conventional tetrameric antibody directed to the other antigen. The invention further relates to uses of the anti-TL1A binding proteins and anti-TL1A/anti-TNF-? antigen binding proteins, and pharmaceutical formulations thereof.

Abstract: A method for preparing AMG 416, or a pharmaceutically acceptable salt thereof, is provided.

Abstract: An insertion mechanism for a wearable drug delivery device that deploys a small gauge flexible cannula with support of a coaxial rigid trocar or hollow needle. After insertion, the trocar or hollow needle is withdrawn leaving the cannula in place for drug delivery. The insertion mechanism may also include an insertion mechanism housing having a proximal and distal end, a manifold configured to fluidly connect the hollow interior of the cannula and the fluid pathway connector, and a manifold guide carrying the manifold and movable between a first position and a second position. A hub carries the trocar and is removably connected to the manifold guide. An insertion biasing member may be initially retained in an energized state between the proximal end of the insertion mechanism housing and the hub, and a retraction biasing member may be initially retained in an energized state between the hub and the manifold guide.

Abstract: Described herein are novel PRMT5 inhibitors of Formula I and pharmaceutically acceptable salts thereof, as well as the pharmaceutical compositions thereof. Compounds of the present invention are useful for inhibiting PRMT5 activity and may have use in treating proliferative, metabolic and blood disorders.

Abstract: The present invention relates to neutralizing antibodies of the human pituitary adenylate cyclase activating polypeptide type I receptor (PAC1) and pharmaceutical compositions comprising such antibodies. Methods of treating or preventing headache conditions, such as migraine and cluster headache, using the neutralizing antibodies are also described.

Abstract: Provided herein are myeloid cell leukemia 1 protein (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, or a stereoisomer thereof; 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: The invention provides a method for culturing mammalian cells. The method provides greater control over cell growth to achieve high product titer cell cultures.

Abstract: Methods of fingerprinting a specific molecule in a composition using nuclear magnetic resonance (NMR) is disclosed. The disclosed NMR methods provide several modifications and improvements over existing NMR techniques. In some embodiments, the methods include applying a cycle of signal processing steps, including applying a radio frequency (RF) pulse, applying a gradient pulse having a pulse length less than or equal to 1000 ?s, and applying a water suppression technique (WET). In some embodiments, the methods further include repeating the cycle for at least 3 times to acquire an enhanced signal of the composition.

Abstract: A drug delivery device includes a container for storing a drug, the container having a stopper for expelling the drug; an injection drive comprising an energy source for directly or indirectly acting on the stopper to expel the drug; a sensor for detecting contact between the drug delivery device and a body of a patient; and a user interface (UI) for activating or causing the activation of the injection drive. The device is operative for drawing attention to the UI, if the sensor detects contact between the drug delivery device and the body of the patient, to thereby indicate that the injection drive is ready to be activated, which activation is the next step in the drug administration process.

Abstract: Provided herein are methods of modulating Fc gamma Receptor (Fc?R)-mediated cytotoxicity of an antibody composition. In exemplary embodiments, the method comprises (1) increasing or decreasing the amount of terminal ?-galactose at the N-297 glycosylation site of panitumumab, or increasing or decreasing the amount of panitumumab molecules that comprise G1, G1a, G1b and/or G2 galactosylated glycan at the N-297 site, (2) increasing or decreasing the amount of panitumumab molecules that comprise fucosylated glycan at the N-297 site, or increasing or decreasing the amount of panitumumab molecules that comprise afucosylated glycan at the N-297 site, and (3) increasing or decreasing the amount of panitumumab molecules that comprise a high-mannose glycan at the N-297 site.

Abstract: The present invention provides bispecific antibody constructs of a specific Fc modality characterized by comprising a first domain binding to BCMA, a second domain binding to an extracellular epitope of the human and/or the Macaca CD3? chain and a third domain, which is the specific Fc modality. Moreover, the invention provides a polynucleotide, encoding the antibody construct, a vector comprising this polynucleotide, host cells, expressing the construct and a pharmaceutical composition comprising the same.

Abstract: A drug delivery device includes a housing defining a shell, a drug delivery assembly at least partially disposed within the housing, a cap defining an opening and being adapted to at least partially cover an end of the housing, at least one electronic component, a power source which powers the at least one electronic component, and a switch assembly. The drug delivery assembly comprises a guard which engages an inner surface of the housing and is movable between a first position, a second position, and a third position relative to the housing and is adapted to restrict external contact with a cannula. The switch assembly causes the power source to provide power to the at least one electronic component when the cap is removed from the housing, restrict the power source from providing power when the cap is coupled to the housing and the guard is in the first position, and cause the power source to provide power when the cap is coupled to the housing and the guard is in the third position.

Abstract: The present invention relates to methods for detecting and quantifying intact protein-polynucleotide conjugate molecules in various sample matrices. In particular, the methods utilize triplex forming oligonucleotides in combination with protein-specific binding partners to respectively detect the polynucleotide and protein components of the conjugate molecules.

Abstract: A drug delivery device includes a blunt cannula and a reservoir. The blunt cannula has a cylindrical wall that defines an axial passage between a first end and a second end of the blunt cannula. The wall has at least a first tapered region at the first end to define an opening in fluid communication with the axial passage and adapted at the first end to resist interruption of fluid flow through the axial passage and out of the first end of the blunt cannula. The reservoir is connected to the second end of the blunt cannula.

Abstract: The present disclosure provides combination therapy with GDF15 molecules. 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. In one embodiment, combination therapy comprises administration of a GDF15 molecule with a GLP-1R agonist. In another embodiment, combination therapy comprises administration of a GDF15 molecule with a GIPR antagonist.