Abstract: The invention provides for the removal of a large fraction of contaminants from protein preparations while maintaining a high level of recovery using tentacle anion exchange matrix chromatography medium. Using the methods of the invention, leached affinity chromatography contaminants can be removed from recombinant protein preparations.

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: The invention encompasses methods of treatment of interferon gamma (IFN-?)-mediated diseases using IFN-? inhibitors, such as anti-huIFN-? antibodies, wherein levels of expression of one or more biomarkers are determined either before administration of the IFN-? inhibitor and/or after administration. Also contemplated are methods of treatment using particular, pharmacodynamically effective doses of an anti-huIFN-? antibody.

Abstract: Disclosed herein are aqueous pharmaceutical formulations comprising denosumab or another human anti-RANKL monoclonal antibody or portion thereof, and characteristics of pH, buffer systems, and amino acid aggregation inhibitors. Also disclosed are presentation of the formulation for use, e.g. in a single-use vial, single-use syringe, or glass container, methods of using the formulations and articles for preventing or treating diseases, and related kits.

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

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

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

Abstract: The present invention relates to methods of purifying proteins containing Fc regions, such as antibodies and Fc fusion proteins. In particular, the present invention relates to a purification method resulting in reduced levels of aggregate protein comprising adsorbing an Fc region-containing protein to a temperature-responsive protein A resin and eluting the protein from the resin at a temperature below 35 C with an elution buffer comprising a chaotropic agent, a sugar alcohol, and at least one amino acid. Methods of separating fully assembled antibodies from half antibody forms thereof using the elution buffer are also described.

Abstract: A biologics manufacturing process that connects the drug substance and drug product processes into an integrated, continuous process.

Abstract: Described herein are compositions and methods related to antigen binding proteins that bind to human ST2, including antibodies. In particular embodiments, the disclosure provides fully human anti-ST2 antibodies and deriviatives and variants thereof. Further provided are nucleic acids encoding such antibodies and antibody fragments, variants, and derivatives. Also, provided are methods of making and using such antibodies including methods of treating and preventing autoimmune and inflammatory disorders.

Abstract: Provided herein are methods of using KRAS G12C inhibitors. These methods of using the inhibitors are useful for treating a number of disorders, including pancreatic, colorectal, and lung cancers.

Abstract: A shielding member for use in sterilizing drug container assemblies includes a housing. The housing includes a first shielding portion and a second shielding portion. The first shielding portion includes a first and second surfaces and a plurality of first bore portions extending between. The second shielding portion having a first and second surfaces and a plurality of second bore portions corresponding to and aligned with the plurality of first bore portions. The first and second bore portions cooperate to form a plurality of receptacles including a plurality of openings in the first surface of the first shielding portion of the housing. The receptacles are sized and configured to receive drug container assemblies, each comprising a container with a container contact region and a seal member disposed adjacent the container contact region to seal the contents of the container at a sealing interface, such that each drug container assembly is exposed out of the housing through one of the openings.

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, 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: An insertion/retraction mechanism for a drug delivery device is disclosed. The insertion/retraction mechanism includes a retraction hub, an insertion hub, an insertion/retraction mechanism housing, and a dual torsion spring system. The retraction hub includes a first primary rotational stop and a second primary rotational stop extending radially inwardly from an inside surface. The insertion hub is disposed inside the retraction hub and comprises a first complementary rotational stop and a second complementary rotational stop extending radially outwardly from an outside surface.

Abstract: The present invention relates to an improved, efficient, scalable process to prepare intermediate compounds, such as compound 5M, having the structure useful for the synthesis of compounds that target KRAS G12C mutations, such as

Abstract: Methods of modulating the properties of a cell culture expressing a protein of interest are provided. In various embodiments the methods relate to the addition of cell-cycle inhibitors to growing cell cultures.

Abstract: The present invention provides a compound of formula (I) or a pharmaceutically acceptable salt thereof, pharmaceutical compositions comprising a compound of the invention, a method for manufacturing compounds of the invention and therapeutic uses thereof.

Abstract: An injector may include a container having a wall with an interior surface and a seal assembly with an interior surface, the interior surfaces of the wall and the seal assembly defining a closed sterile reservoir filled with a drug product. The injector may also include a fluid delivery system comprising a clean, unsheathed, rigid container needle having a point disposed only partially through the seal assembly in a storage state, and disposed through the interior surface of the seal assembly into the sterile reservoir in a delivery state. Further, the injection may include an actuator that is adapted to move the container needle from the storage state to the delivery state.

Abstract: Compounds of formula (I): as defined herein, and synthetic intermediates thereof, which are capable of modulating KIF18A protein thereby influencing the process of cell cycle and cell proliferation to treat cancer and cancer-related diseases. The invention also includes pharmaceutical compositions, including the compounds, and methods of treating disease states related to the activity of KIF18A.