Abstract: Disclosed herein are methods, systems, and kits for determining the total amount of a coating polymer in a dosage form. The coating polymer may be a polydisperse polymer having a plurality of molecular weights. The instant disclosure enables to accurately, reliably, and efficiently determine the total amount of a polydisperse polymer in a dosage form that includes one or more other constituents that have a molecular weight range that overlap with at least some of the polydisperse polymer's molecular weight.

Abstract: Embodiments of the present disclosure include systems and methods for generating an executable batch record for a clinical trial study. The method includes displaying a user interface for having a production user input batch record information comprising via a production user interface (UI), and receiving packaging instructions, a bill of materials, and a lot assignment from the production user. The method further includes producing a preliminary batch record based on the information input by the production user. The method further displaying a customer UI that includes the preliminary batch record and an interface for approving the preliminary batch record, and receiving an approval of the preliminary batch record from a customer user. The method further includes producing an executable batch record for a producer to execute upon customer approval.

Abstract: A method of treating a hard capsule shell to reduce or alleviate stress or reduce the propensity for cracking in the capsule shell. The method includes a step of heating at least a portion of the hard capsule shell to a temperature above a glass transition temperature of the capsule shell but below a melt temperature of the hard capsule shell for a time sufficient to reduce internal stress in the hard capsule shell. The method can be used to reduce cracking of hard capsule shells by application of the heat treatment to the filled capsule shells after fabrication and filling.

Abstract: The present disclosure provides antibody-drug conjugate structures, which include a cleavable linker that links the antibody to the drug and has a first enzymatically cleavable moiety and a second enzymatically cleavable moiety which includes a glycoside selected from a galactoside, a glucoside, a mannoside, a fucoside, O-GlcNAc, and O-GalNAc. The disclosure also encompasses compounds and methods for production of such conjugates, as well as methods of using the conjugates.

Abstract: The present disclosure provides antibody-drug conjugate (ADC) structures, which include a camptothecine or a camptothecine derivative linked to a polypeptide (e.g., an antibody) through a linker. The disclosure also encompasses compounds and methods for production of such conjugates, as well as methods of using the conjugates.

Abstract: A dry granulation process using a twin-screw extruder for granulating a powder mixture which includes at least one active ingredient and at least one carrier. The process includes steps of kneading the powder mixture in the screw barrel of the twin-screw extruder at a barrel temperature below a melting point of the at least one active ingredient and a melting point or a glass transition temperature of the at least one carrier to provide a kneaded powder mixture, and extruding the kneaded powder mixture to form granules. Granules and tablets produced using the dry granulation process in the twin-screw extruder are also provided.

Abstract: A method of treating a soft or hard capsule shell to reduce or alleviate stress in the capsule shell. The method includes a step of heating at least a portion of the soft or hard capsule shell to a temperature above a glass transition temperature of the capsule shell but below a melt temperature of the capsule shell for a time sufficient to reduce internal stress in the capsule shell. The method can be used to reduce cracking of hard or soft capsule shells by application of the heat treatment to the filled capsule shells after fabrication and filling.

Abstract: The present invention is directed to an immediate release and extended release capsule or capsule fill which mitigates the abuse of abuse-susceptible active pharmaceutical ingredients by direct intravenous injection. The fill comprises a parenteral abuse resistant liquid formulation which when mixed with water and heated, results in a turbid, viscous or bubbling mixture that is not injectable with a standard insulin syringe. The abuse-susceptible active pharmaceutical ingredient is selected from the group consisting of opiates, opioids, tranquillizers, stimulants and narcotics.

Abstract: A user interface (UI) for providing optimized parameters for a fluid bed granulation process may include a first user input field for receiving intrinsic properties of an input powder, a second user input field for receiving granulation requirements for granules formed from the input powder during the fluid bed granulation process, a third user input field for receiving operational capabilities of a fluid bed granulation system, and an output field configured to display optimal process parameters for the fluid bed granulation system. The optimal process parameters may be determined by thermodynamically modeling granulation of the input powder in the fluid bed granulation system.

Abstract: Provided are humidity control devices, systems, and methods of controlling humidity in an enclosed container. A humidity control device can comprise a cap configured to attach to a container; a first tubular member passing through the cap to form a first portion of the first tubular member and a second portion of the first tubular member, the first portion comprising a proximal end extending away from the cap and the second portion comprising an inlet configured to receive a fluid, wherein when the cap is attached to the container, the first portion is within the container and the second portion is outside of the container, wherein the proximal end of the first tubular member comprises an outlet for delivering the fluid to an interior space of the container.

Abstract: The present disclosure provides anti-CD22 antibody-maytansine conjugate structures. The disclosure also encompasses methods of production of such conjugates, as well as methods of using the same.

Abstract: Enteric softgel capsules comprise a fill material and an enteric shell composition, characterized in that the enteric nature of the capsules may be achieved without an enteric coating or added conventional enteric polymers.

Abstract: Provided are pharmaceutical compositions and methods for preparing pharmaceutical compositions comprising wax coated tablets. Specifically, a wax coating can be applied to a pharmaceutical tablet prior to the film coating process.

Abstract: The present disclosure provides activated formylglycine-generating enzymes (FGE), methods of producing activated FGE, and their use in methods of producing a protein comprising a formylglycine (FGly) residue. The methods of producing activated FGE, as well as methods of use of activated FGE in producing FGly-containing proteins, include both cell-based and cell-free methods. Compositions and kits that find use, e.g., in practicing the methods of the present disclosure are also provided.

Abstract: Enteric softgel capsules comprise a fill material and an enteric shell composition, characterized in that the enteric nature of the capsules may be achieved without an enteric coating or added conventional enteric polymers.

Abstract: The present disclosure provides antibody-drug conjugate structures, that include a cleavable linker having a sulfatase-cleavable moiety. The disclosure also encompasses methods of production of such conjugates, as well as methods of using the same.

Abstract: The present disclosure provides antibodies specific for Mucin 1. Nucleic acids that encode one or both of the variable chains of an antibody of the present disclosure are also provided, as are cells that include such nucleic acids. Also provided are compositions that include the antibodies of the present disclosure, including in some instances, pharmaceutical compositions. Methods of making and using the antibodies of the present disclosure are also provided. In certain aspects, provided are methods that include administering to an individual having a cell proliferative disorder a therapeutically effective amount of an antibody of the present disclosure, where the antibody is administered to the individual to enhance an immune response, e.g., a T cell response, to abnormally proliferating cells of the cell proliferative disorder. The antibodies are also useful in various diagnostic, and monitoring applications, which are also provided.

Abstract: The present disclosure provides anti-CD25 antibody-maytansine conjugate structures. The disclosure also encompasses methods of production of such conjugates, as well as methods of using the same.

Abstract: A controlled release fill composition for use in soft or hard capsules, soft- or hard-shell capsules encapsulating controlled release fill compositions, a method of producing a softgel capsule with a controlled release fill composition encapsulated in the soft gel capsule shell. The controlled release fill composition includes an active pharmaceutical ingredient; polyethylene oxide having a number average molecule weight of from 0.05 M daltons to 15 M daltons; and at least one of water or a hydrophilic carrier having a number average molecule weight of from 200 daltons to 5000 daltons. Also, in the controlled release fill composition either the polyethylene oxide is present in an amount of at least 21.5 wt. %, based on a total weight of the controlled release fill composition, or the hydrophilic carrier is present in an amount up to 65 wt. %, based on a total weight of the controlled release fill composition.

Abstract: Systems and methods for automated data analysis and reporting of pharmaceutical batch production records are provided. In response to receiving a user command to generate a batch report, the method can comprise automatically performing one or more statistical analyses on raw batch data extracted from one or more batch manufacturing records, generating one or more figures and one or more tables using the analyzed data, identifying one or more discussion boxes that are relevant to the analyzed data, compiling a batch report comprising the one or more identified discussion boxes, saving the batch report in a memory, and displaying the batch report on a user device.