Abstract: Antibodies, portions, and fusion proteins thereof to CD63 are provided. Also provided are nucleic acid sequences encoding same. Also provided are compositions comprising and methods of using same, e.g., for treating a patient in need thereof.

Abstract: MCE assays and reagents to assess purity and to identify impurities in protein drug product samples are provided. Methods for analyzing analytes in a protein drug sample are provided.

Abstract: A scalable cloud-based data processing and computing platform to support a large volume data pipeline.

Abstract: A method for assessing chromatographic column integrity may include introducing acetone into a chromatographic column and measuring absorbance values of an eluate of the chromatographic column. The method for assessing chromatographic column integrity may also include generating a first data structure based on the absorbance values, implementing a fitting algorithm based on the first data structure to generate a transition function, generating a second data structure based on the transition function, and generating a transition plot based on the first and second data structures, wherein the transition plot includes transition plot-related data. A value of a performance parameter may be generated based on the transition plot-related data.

Abstract: Aspects of the present disclosure relate to a method of regenerating a hydrophobic interaction chromatography column to which a load mass has been applied, the method comprising passing one or more column volumes of an alkaline solution through hydrophobic interaction media within the column, wherein the alkaline solution exhibits a pH of between about 10 and about 14, and a conductivity of between 0.5 mS/cm and about 10 mS/cm, wherein material bound to the hydrophobic interaction media is removed. In some cases, the alkaline solution may include sodium hydroxide at a concentration of between, e.g., about 0.1 mM and 10 mM.

Abstract: Methods and system for characterizing a protein using a chromatographic system having a protein A chromatography resin and electrospray ionization mass spectrometer run under native conditions are provided.

Abstract: A fixture for an automatic needle injection is disclosed, wherein the fixture comprises a housing including a chamber, the housing including a first plurality of walls, a second plurality of walls, and a third plurality of walls, a holder, and a membrane; wherein the membrane is contained in the holder, the holder is secured within a portion of the housing, and the holder is configured to allow a portion of a needle of a syringe to pass through a portion of the holder and into the chamber of the housing.

Abstract: Mice that comprise a replacement of endogenous mouse IL-6 and/or IL-6 receptor genes are described, and methods for making and using the mice. Mice comprising a replacement at an endogenous IL-6R? locus of mouse ectodomain-encoding sequence with human ectodomain-encoding sequence is provided. Mice comprising a human IL-6 gene under control of mouse IL-6 regulatory elements is also provided, including mice that have a replacement of mouse IL-6-encoding sequence with human IL-6-encoding sequence at an endogenous mouse IL-6 locus.

Abstract: Methods and system for protein characterization using online chromatography and electrospray ionization mass spectrometry are provided.

Abstract: Multispecific binding molecules (MBMs) comprising an N-terminal scFv, a first Fab and a second Fab, MBM conjugates comprising the MBMs and cytotoxic or cytostatic agents, pharmaceutical compositions containing the MBMs and MBM conjugates, methods of using the MBMs, MBM conjugates and pharmaceutical compositions for treating cancer, nucleic acids encoding the MBMs, cells engineered to express the MBMs, and methods of producing MBMs.

Abstract: Non-aqueous membrane emulsion methods for producing polymeric and polymer-coated microparticles are provided. Some embodiments provide methods for producing a sustained release or controlled release microparticle by combining micronized protein powder and a polymer into a hydrocarbon solvent to form a non-aqueous first solution, agitating the first non-aqueous solution to form a suspension, feeding the suspension into a dispersion pump, wherein the suspension is infused through a porous membrane into a continuous phase comprising a fluorocarbon liquid and a fluorosurfactant to form a hydrocarbon-in-fluorocarbon emulsion. The hydrocarbon solvent, the fluorocarbon liquid, and the fluorosurfactant are removed, and the microparticles are collected.

Abstract: Multispecific binding molecules (MBMs) comprising an N-terminal scFv, a first Fab and a second Fab, MBM conjugates comprising the MBMs and cytotoxic or cytostatic agents, pharmaceutical compositions containing the MBMs and MBM conjugates, methods of using the MBMs, MBM conjugates and pharmaceutical compositions for treating cancer, nucleic acids encoding the MBMs, cells engineered to express the MBMs, and methods of producing MBMs.

Abstract: The present disclosure relates to IL 12 receptor agonists with improved therapeutic profiles.

Abstract: The present disclosure provides methods of treating a subject having decreased bone mineral density or at risk of developing decreased bone mineral density, and methods of identifying subjects having an increased risk of developing decreased bone mineral density.

Abstract: The present inventions provide eukaryotic cells, such as mammalian cells, that comprise adeno-associated virus (AAV) polynucleotides, including AAV capsid proteins (Cap), and are capable of expressing the polypeptides encoded by the AAV polynucleotides, and thereby are capable of producing AAV, including recombinant AAV. The eukaryotic cells also may comprise adenovirus (Ad) polynucleotides. The present inventions also provide methods of expressing AAV polynucleotides, as well as Ad polynucleotides, in eukaryotic cells, such as CHO cells, HEK 293 and BHK cells. The present inventions further provides other products and methods described herein.

Abstract: The present application provides a method for characterizing and/or determining viral clearance capacity of hydrophobic interaction chromatography (HIC) including experimental design for multivariate analysis of viral clearance of HIC. The method provides understanding of the mechanism of the viral clearance using HIC by running a D-Optimal design of experiment including evaluations of multiple factors, such as pH, buffer concentration, column loading concentration, flow rate of column, or hydrophobic strength of the HIC column.

Abstract: Methods for selecting a cancer patient for immunotherapy comprise establishing a total passenger gene mutation burden from a tumor of a cancer patient, generating a background distribution for the mutational burden of the tumor, normalizing the total passenger gene mutation burden against the background distribution, and categorizing the cancer patient as an immunotherapy responder when the total passenger gene mutation burden is greater than the mean of the background distribution. When the cancer patient is an immunotherapy responder, the patient may be administered an immunotherapy regimen that comprises activation/inhibition of T cell receptors that promote T cell activation and/or prolong immune cytolytic activities.

Abstract: An auto-injector may include a container capable of comprising a medicament; a shuttle coupled to the container and on a horizontal path with a first state and a second state; an energy source configured to release energy to translate the container and to translate the shuttle, preferably the energy source is pressurized fluid from a can; an impediment preventing horizontal movement of the shuttle before activation of the auto-injector; and a needle having a first end configured to extend out of the auto-injector, and a second end configured to extend into the container, wherein the second end of the needle and the container are not in fluid communication with one another before activation of the auto-injector.

Abstract: An injection device includes a carrier, a needle, a driver coupled to the needle, the driver being slidable relative to the carrier between a retracted configuration and a deployed configuration, a shuttle configured to move the driver between the retracted configuration and the deployed configuration, and a stop configured to move from a first configuration to a second configuration, wherein the stop is configured to maintain the driver in the deployed configuration, and movement of the stop from the first configuration to the second configuration allows the shuttle to move the driver from the deployed configuration to the retracted configuration.

Abstract: Systems and method for producing a small-scale mixer are provided. In some implementations, a method for includes obtaining dimensions of an at-scale mixer. The method also includes determining first dimensions of the small-scale mixer based on respective dimensions of the at-scale mixer. The method further includes determining second dimensions of the small-scale mixer independent of the dimensions of the at-scale mixer. Additionally, the method includes generating the small-scale mixer using the first dimensions and the second dimensions using a three-dimensional printer.