Abstract: The present disclosure provides circularized antibody molecules and methods of their production and use.

Abstract: Computational systems and methods for predicting amino acid position(s) within a target peptide presented in a complex with a major histocompatibility complex (MHC) molecule (MHC-target peptide complex), the amino acid position(s) being involved in interacting with an antigen-recognition molecule that recognizes said MHC-target peptide complex, are presented herein. Computational systems and methods for estimating a number of off-target peptide(s) for an antigen-recognition molecule that recognizes a target peptide presented in a complex with a major histocompatibility complex (MHC) molecule (MHC-target peptide complex) is presented herein. Computational systems and methods for ranking potential target peptides to mitigate off-target toxicity are presented herein. Such computational systems and methods can streamline development of effective, well tolerated antigen-recognition molecules to treat diseases.

Abstract: The present disclosure relates to IL10 agonists with improved anti-tumor therapeutic efficacy and uses thereof. Certain IL10 agonists disclosed herein comprise an IgG Fc domain, a linker moiety, and an IL10 moiety.

Abstract: The disclosure relates to methods for treating or inhibiting the growth of a tumor, wherein the methods include selecting and administering to a subject in need thereof a therapeutically effective amount of an IL-4/IL-13 pathway inhibitor and a therapeutically effective amount of a programmed death 1 (PD-1) inhibitor. In certain embodiments, the IL-4/IL-13 pathway inhibitor enhances the anti-tumor efficacy of PD-1 blockade.

Abstract: The present disclosure provides methods of treating subjects having skin cancer or at risk of developing skin cancer, and methods of identifying subjects having an increased risk of developing skin cancer.

Abstract: Antigen binding molecules (ABMs) comprising Fab domains in non-native configurations, ABM conjugates comprising the ABMs and cytotoxic or cytostatic agents, pharmaceutical compositions containing the ABMs and ABM conjugates, methods of using the ABMs, ABM conjugates and pharmaceutical compositions for treating cancer, nucleic acids encoding the ABMs, cells engineered to express the ABMs, and methods of producing ABMs.

Abstract: In one instance, disclosed herein is an auto-injector, the auto-injector including: a housing; a container disposed within the housing, the container configured to store a medicament; a canister disposed within the housing, the canister configured to release a pressurized medium to expel the medicament from the container; a shroud coupled to the housing, the shroud configured to move between a first position and a second position relative to the housing to cause the pressurized medium to be released by the canister; and a mandrel assembly disposed within the housing, the mandrel assembly configured to urge the shroud outward relative to the housing toward the first position after the pressurized medium is released by the canister.

Abstract: The present disclosure relates to molecules capable of binding to both CD20 and PD1, as well as pharmaceutical compositions comprising such molecules and methods of use thereof.

Abstract: The present disclosure pertains to method and system of characterizing a protein using an electrospray ionization source.

Abstract: Systems and methods to characterize dimerization interfaces at the subdomain level of a protein are provided. An exemplary method includes digesting a protein dimer sample into subdomains, labeling the digested protein sample, isolating labeled dimeric and monomeric subdomain fragments, and peptide mapping the labeled sample to determine where the dimer fragments are labeled and where the dimer fragments are not labeled. Regions that show decreased labeling extents in the dimer fraction than that in the monomer fraction are likely involved or in close proximity to the dimerization interface.

Abstract: The present invention provides methods to quickly and efficiently assess the effect of antibody variants, including PTMs, e.g., glycosylation, oxidation, and deamidation variants, on the binding between the antibody and FcRn. In particular, the present invention is based, at least in part, on the development of an online, two dimension liquid chromatography (2D-LC) method for assessing binding between antibody variants and FcRn. In one aspect, the online 2D-LC is coupled with mass spectrometry (MS). The present invention allows for differentiation of antibody variants by peak pattern and retention time profile by affinity chromatography, and identification of these variants by mass spectrometry analysis.

Abstract: An auto-injector, including a housing and a cartridge disposed within the housing, the cartridge enclosing a medicament. The auto-injector further includes a fluid conduit configured to deliver the medicament from the cartridge to a patient and movable from a retracted configuration to a deployed configuration associated with administering the medicament, and a temperature sensor configured to determine a temperature of the medicament. A controller the temperature sensor is configured to: send a first signal to an external device when the temperature sensor senses that a temperature of the medicament rises above a threshold temperature.

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: A packaging comprising a tray having a body surrounding an exposed cavity and a groove; a lip surrounding the opening, wherein the lip extends radially outward from the cavity and defines a periphery of the tray; a retainer for covering a portion of the opening of the tray, the retainer having an aperture, wherein the aperture corresponds to the groove of the tray; a removable cover; and an auto-injector contained within the cavity, wherein the auto-injector is pre-filed with a medicament or other fluid.

Abstract: The present invention provides rapid, sensitive high-throughput methods and systems for characterizing peptides or proteins using hydrophobic interaction chromatography-coupled native mass spectrometry to improve manufacturing process of biopharmaceutical products, such as identifying impurities during antibody purification, monitoring post-translational modification variants during production, or characterizing drug-to-antibody ratio of antibody-drug conjugates. The separation profiles of the peptides or proteins are generated and compared to identify or qualify the peptides or proteins.

Abstract: This disclosure relates to IL-2 variants and methods of use thereof, including methods of treating or inhibiting a cancer or tumor. The IL-2 variants may have reduced ability in binding to or activating IL-2R?. The IL-2 variants may retain the ability in binding to or activating IL-2R? and/or IL-2R?. In addition, the IL-2 variants may have decreased Treg activity but maintain the capacity to activate NK cells and T effector cells.

Abstract: The present application provides methods and systems for identifying host cell protein impurities which have enzymatic activities in biopharmaceutical products and in samples during manufacturing processes. The present application provides various activity-based probes to characterize different enzyme classes of host cell protein impurities including probes containing functionalized molecules with reporter or affinity-based tags.

Abstract: Methods for detecting and/or discriminating between post-translational modification variants of an antibody of interest in a sample. The methods including: contacting a sample comprising one or more antibodies of interest with a protease to digest the sample into antibody fragments; separating antibody fragments by molecular weight and/or charge in one or more capillaries using capillary electrophoresis; eluting separated antibody fragments from the one or more capillaries; and determining the mass of the eluted antibody fragments by mass spec analysis, thereby detecting and/or discriminating between post-translational modification variants of the antibody of interest.

Abstract: The present invention provides ophthalmic formulations having high concentrations of vascular endothelial growth factor (VEGF) receptor fusion protein and high stability during storage. Methods for treating angiogenic eye disorders using the high concentration formulations are also provided.

Abstract: BANF1, PPP2CA, and ANKLE2 were identified as genes that promote tau aggregation when disrupted. Improved tauopathy models such as cells, tissues, or animals having mutations in or inhibition of expression of BANF1 and/or PPP2CA and/or ANKLE2 are provided. Methods of using such improved tauopathy models for assessing therapeutic candidates for the treatment of a tauopathy, methods of making the improved tauopathy models, and methods of accelerating or exacerbating tau aggregation in a tauopathy model are also provided.