Abstract: A stopper retainer comprises a body having an upper surface, a lower surface, and at least one fastener, and a plurality of projections extending from the lower surface of the body, each of the plurality of projections being sized to at least partially fit within a lumen of a syringe barrel.

Abstract: The present invention relates to a method of measuring at least one product quality attributes, including critical quality attributes (e.g., oxidation, C-terminal lysine, aggregation, N-terminal glutamine cyclization.) by an online liquid chromatography system, wherein the liquid chromatography system is running a hydrophobic interaction chromatography (HIC) method.

Abstract: A torque-limiting device comprises a plunger rod holder defining a piston cavity for receiving at least a portion of a plunger rod, a moveable stop element, a dowel disposed adjacent the stop element, a spring disposed adjacent the dowel, and a syringe barrel holder defining a barrel cavity for receiving at least a portion of a syringe barrel.

Abstract: The present invention provides methods of treating malaria comprising administration of compounds of Formula (I) or a pharmaceutically acceptable salt thereof, to a subject in need thereof, wherein the variables are as defined herein. The invention also provides uses of the compounds of Formula (I), as defined herein, for the possible inhibition of plasmepsin X, plasmepsin IX or plasmepsin X and IX activity, for treating a Plasmodium infection, and for treating malaria. Also provided are methods of treatment further comprising administration of one or more additional anti-malarial compounds.

Abstract: Phosphonate linkers and their use for delivering compounds with passive cell permeability into a cell wherein the phosphonate group facilitates cellular retention of the compound are described.

Abstract: The present invention relates to a perfusion bioreactor for co-culturing, wherein the bioreactor grows cells in two separate environments and enables communication across environments and populations. The chambers' contents are continuously mixed to expose the environment (or cell population) of each chamber to the secreted products of the other chamber. The said bioreactor comprises at least, but not limited to, two chambers, with separate cell populations with at least two separate environments independently selected from aerobic or anaerobic environment and media favorable to cell growth. The bioreactor allows for multiple samples to be collected during an experiment to enable various analytical techniques and results. Additionally, the bioreactor comprises a multi-chamber cell culture system capable of emulating the gastro-intestinal tract.

Abstract: The present disclosure describes combination therapies comprising an antagonist of Programmed Death 1 receptor (PD-1) and a multi-RTK inhibitor, and the use of the combination therapies for the treatment of cancer. The multi-RTK inhibitor may be represented by Formula (I): wherein R1 is C1-6 alkyl or C3-8 cycloalkyl, R2 is a hydrogen atom or C1-6 alkoxy, and R3 is a hydrogen atom or a halogen atom. A tumor therapeutic agent is disclosed that combines a compound or pharmaceutically acceptable salt thereof represented by Formula I and an anti-PD-1 antibody.

Abstract: This invention provides compositions, compounds, and uses thereof, wherein said compounds comprise a single strand oligonucleotide that may form a short oligonucleotide hairpin or stem loop molecule with self complementary base pairing of less than 12 base pairs that bind to RIG-I and activate the RIG-I pathway.

Abstract: The instant invention is related to a novel solid form of ceftolozane sulfate (the DMAc solvate of ceftolozane sulfate (Form 3)), compositions comprising ceftolozane sulfate DMAc solvate (Form 3), synthesis of Form 3 and an improved crystallization process using Form 3 to prepare ceftolozane sulfate Form 2. Novel compositions also include ceftolozane sulfate solid Form 3 and/or other crystalline and amorphous solid forms of ceftolozane.

Abstract: The present disclosure provides an in vitro cell based potency assay to determine the relative potency of a composition, including a pharmaceutical composition, comprising an mRNA encapsulated in a lipid nanoparticle (LNP) as compared to a reference sample. Also provided is a process for releasing or accepting a batch of a pharmaceutical composition comprising an mRNA encapsulated in an LNP using the in vitro cell based potency assay. The methods and processes described comprise (i) transfecting a population of cells with a test sample of the composition, (ii) transfecting a different population of cells with a reference sample of the pharmaceutical composition, wherein the cells in step (ii) are the same cell type as the cells in step (i); (iii) detecting the amount of expression of a polypeptide encoded by the mRNA in the transfected cells; and comparing the amount of expression, thereby determining the relative in vitro potency of the composition.

Abstract: Provided herein are cyclic polypeptide compounds that can, e.g., bind specifically to human proprotein convertase subtilisin/kexin type 9 (PCSK9) and optionally also inhibit interaction between human PCSK9 and human low density lipoprotein receptor (LDLR), and pharmaceutical compositions comprising one or more of these compounds. Also provided are methods of reducing LDL cholesterol level in a subject in need thereof that include administering to the subject one or more of the cyclic polypeptide compounds or a pharmaceutical composition provided herein.

Abstract: The present invention relates to tyrosine-specific functionalized insulin analogs and processes of making such tyrosine-specific functionalized insulin analogs using R-3H-1,2,4-triazoline-3,5-(4H)diones (PTAD).

Abstract: Disclosed herein is a compound of formula (I), or a pharmaceutically acceptable salt thereof: (I). Also disclosed herein are uses of a compound disclosed herein in the potential treatment or prevention of an IDO- and/or TDO-associated disease or disorder. Also disclosed herein are compositions comprising a compound disclosed herein. Further disclosed herein are uses of a composition in the potential treatment or prevention of an IDO- and/or TDO-associated disease or disorder.

Abstract: The present invention provides capsular polysaccharides from Streptococcus pneumoniae serotypes identified using NMR. The present invention further provides polysaccharide-protein conjugates in which capsular polysaccharides from one or more of these serotypes are conjugated to a carrier protein such as CRM197. Polysaccharide-protein conjugates from one or more of these serotypes may be included in multivalent pneumococcal conjugate vaccines having polysaccharides from multiple additional Steptococcus pneumoniae serotypes.

Abstract: In one aspect of the subject invention, a labeling shell is provided for a drug vial having a glass reservoir and an opening sealed by an elastomeric stopper, the labeling shell including: a polymeric tubular body formed to accommodate the reservoir of the drug vial, the tubular body having a first open end defining a first opening smaller than a diameter of the reservoir of the drug vial so as to prevent passage therethrough of the reservoir, wherein the elastomeric stopper is exposed through the first end with the reservoir being accommodated in the tubular body; and, a polymeric cap removably mountable to the tubular body to selectively cover the elastomeric stopper of the drug vial with the reservoir being accommodated in the tubular body. Advantageously, the subject invention provides a labeling surface for a drug vial, while also providing restricted access to the drug vial to limit tampering therewith.

Abstract: The disclosure provides crystalline forms for certain synthetic intermediates for making belzutifan, a HIF-2? inhibitor, useful for the treatment of cancer. The disclosure also provides processes for isolating the crystalline forms.

Abstract: The present invention relates to pegylated amino acid compounds of Formula I: and pharmaceutically acceptable salts thereof, wherein X, R1, R2, R3A, R3B and n are as defined herein. The present invention also relates to compositions which comprise a pegylated amino acid compound of the invention or a pharmaceutically acceptable salt thereof, and a pharmaceutically acceptable carrier, in combination with a high concentration of an active biological ingredient (ABI). In embodiments of the invention, the ABI is an anti-PD-1 antibody or antigen binding fragment thereof that specifically binds human programmed death receptor 1 (PD-1). The invention further relates to methods for lowering the viscosity of an aqueous solution of a pharmaceutical composition comprising adding a compound of the invention to the solution.

Abstract: Novel compounds of structural formula (I), and the pharmaceutically acceptable salts thereof, are inhibitors of Nav1.8 channel activity and may be useful in the treatment, prevention, management, amelioration, control and suppression of diseases mediated by Nav1.8 channel activity. The compounds of Formula I may be useful in the treatment, prevention or management of pain disorders, cough disorders, acute itch disorders, and chronic itch disorders.

Abstract: The present invention relates to methods for the recombinant expression of chlamydia major outer membrane protein (MOMP) comprising transforming a population of E. coli host cells with an expression vector comprising a nucleic acid molecule that encodes chlamydia MOMP and encodes a leader sequence for targeting the MOMP to the outer membrane of the cell, wherein the nucleic acid molecule is operatively linked to a promoter. The method of the invention allows expression of MOMP in the outer membrane of the cell, which leads to protein folding that is more like native MOMP relative to a MOMP protein that is expressed intracellularly. Also provided by the invention are uses of the recombinant MOMP in pharmaceutical compositions and methods for the treatment and/or prophylaxis of chlamydia infection and/or the effects thereof.

Abstract: Antibody drug conjugates (ADCs) comprising an antibody conjugated to an anti-inflammatory therapeutic agent via a phosphate-based linker with tunable extracellular and intracellular stability are described.