Abstract: A well for electrically stimulating at least one cell. The well includes a bottom portion and comprises an adaptive electrode arrangement for introducing an electric field into the well. The adaptive electrode arrangement includes a pair of electrodes disposed within the well. Each electrode of the pair of electrodes has a distal end and is independently and axially displaceable relative to the other electrode and the bottom portion of the well. The distal end of each electrode of the pair of electrodes is in contact with the bottom portion of the well, ensuring a uniform and constant electric field is applied within the well.

Abstract: The present invention relates to novel antibodies, particularly antibodies directed against deletion mutants of epidermal growth factor receptor and particularly to the type III deletion mutant, EGFRvIII. The invention also relates to human monoclonal antibodies directed against deletion mutants of epidermal growth factor receptor and particularly to EGFRvIII. Diagnostic and therapeutic formulations of such antibodies, and immunoconjugates thereof, are also provided.

Abstract: The invention relates to the formulation of pharmaceutical compositions of etanercept. The invention also relates to methods of removing buffer and of formulating pharmaceutical compositions of etanercept.

Abstract: Described herein are bispecific proteins specific for BAFF and B7RP1, nucleic acids encoding such proteins, methods of making such proteins, and uses for such proteins.

Abstract: Provided herein are methods of determining product quality of an antibody composition, wherein the ADCC activity level of the antibody composition is a criterion upon which product quality of the antibody composition is based. In exemplary embodiments, the method comprises (i) determining the total afucosylated (TAF) glycan content of a sample of an antibody composition; and (ii) determining the product quality as acceptable and/or achieving the ADCC activity level criterion when the TAF glycan content determined in (i) is within a target range. Related methods of monitoring product quality and methods of producing an antibody composition are further provided herein.

Abstract: The present invention relates to compositions comprising erenumab and one or more erenumab variants, including isomerization variants, deamidation variants, acidic variants, and HMW species. Pharmaceutical formulations comprising the erenumab compositions and methods of using and characterizing the compositions are also described.

Abstract: Drug delivery devices and related methods of assembly are disclosed. The drug delivery device may include a container including a wall with an interior surface and a seal member with an end surface. The interior surface of the wall and the end surface of the seal member may define a reservoir filled with a drug. A fluid pathway assembly may be connected to the container and include an overmold member that covers a length of a container access needle and which defines an enclosed space with the seal member. The overmold member may be moveable relative to the seal member to carry the container access needle between a storage position, where a point of the container access needle is disposed exterior to the reservoir, and a delivery position, where the point extends through the end surface of the seal member into the reservoir.

Abstract: The invention provides a method for controlling contaminants in biopharmaceutical purification processes by using light scattering and UV absorbance to establish a determinant. The invention makes use of multi-angle light scattering (MALS) and UV as a continuous monitoring system to provide information about the elution peak fractions in real-time instead of conventional pooling methods that rely on a predetermined percent UV peak max value to initiate the pooling process; regardless of product quality.

Abstract: The present invention relates to RNAi constructs for reducing expression of the SLC30A8 gene. Methods of using such RNAi constructs to treat or prevent disease, such as pre-diabetes or diabetes are also described.

Abstract: The present invention relates to a bispecific single chain antibody molecule comprising a first binding domain capable of binding to an epitope of human and non-chimpanzee primate CD3 epsilon chain, wherein the epitope is part of an amino acid sequence comprised in the group consisting of SEQ ID NOs. 2, 4, 6, and 8, and a second binding domain capable of binding to prostate-specific membrane antigen (PSMA). The invention also provides nucleic acids encoding said bispecific single chain antibody molecule as well as vectors and host cells and a process for its production. The invention further relates to pharmaceutical compositions comprising said bispecific single chain antibody molecule and medical uses of said bispecific single chain antibody molecule.

Abstract: This invention provides compositions comprising a protein and an absorption enhancer, methods for treating inflammatory disorders, such as irritable bowel disease (IBD) comprising administering same, and methods for oral, intra-rectal, or other gut-related administration of a protein with an enzymatic activity, comprising orally, intra-rectally, or other gut-related administering same.

Abstract: The present invention relates to multispecific transthyretin (TTR) complexes useful as multispecific binding proteins. The multispecific TTR complexes described herein are particularly useful in binding to one, two, or more epitopes which may be present on one or more proteins. Methods for treating diseases using the TTR complexes of the present invention are described herein.

Abstract: A drug delivery system includes a drug delivery device that delivers medicament to a user and a storage container having a container body that defines at least one storage compartment. The storage container includes a controller, at least one temperature sensor associated with the at least one storage compartment, at least one temperature control device associated with the at least one storage compartment, and at least one retention mechanism coupled to the storage container. In response to a user input, the controller is adapted to activate the at least one temperature control device to adjust the temperature in the at least one storage compartment to an administration temperature and transmit a signal to the at least one retention mechanism to release the drug delivery device from the at least one storage compartment after the temperature in the at least one storage compartment reaches the administration temperature.

Abstract: An insertion mechanism for a drug delivery device including a trocar, a housing, and a manifold in fluid communication with a fluid pathway connector and movable relative to the housing between a first manifold position adjacent to a proximal end of the housing and a second manifold position adjacent to a distal end of the housing. A hub carrying the trocar or hollow delivery needle is removably connected to the manifold, the hub being movable relative to the housing between a first hub position adjacent to the proximal end of the housing and a second hub position adjacent to the distal end of the housing. A power source is configured to generate rotational motion. A motion conversion mechanism operatively connects the power source and the hub, and is configured to convert the rotational motion into linear motion of the hub.

Abstract: The invention generally relates to anti-sclerostin antibodies having C-terminal modifications, and compositions comprising such antibodies.

Abstract: The present invention relates to methods of migraine prophylaxis using anti-CGRP receptor antibodies or binding fragments. In particular, methods for preventing or reducing the occurrence of migraine headache in a patient in need thereof comprising administering to the patient an anti-CGRP receptor or binding fragment according to specific dosage regimens are disclosed. Pharmaceutical compositions and administration devices comprising anti-CGRP receptor antibodies or binding fragments for use in the methods are also described.

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.

Abstract: Provided herein are free base crystalline forms, crystalline salts, and an amorphous salts of omecamtiv mecarbil.

Abstract: Drug delivery devices and related methods of assembly are disclosed. The drug delivery device may include a main housing having an exterior surface releasably attachable to a patient, a container disposed in an enclosed space defined by an interior surface of the main housing, and a drive assembly. The container may include a reservoir containing a drug and a stopper. The drive assembly may include drive housing and a tether which slidably engages and is pulled taut against a guide surface of the drive housing. A first end of the tether may be wound around a capstan which is mounted rotatably relative to the drive housing. A second end of the tether may be operably connected to a stopper biasing member. The tether may initially retain the stopper biasing member in an energized state. When released, the stopper biasing member may expand to move the stopper through the reservoir.

Abstract: The present application is directed to heterodimeric antibodies and methods of use.