Abstract: Antibodies that include a sulfatase motif-containing tag in a constant region of an immunoglobulin (Ig) light chain polypeptide are disclosed. The sulfatase motif can be converted by a formylglycine-generating enzyme (FGE) to produce a formylglycine (fGly)-modified Ig light chain polypeptide. An fGly-modified Ig light chain polypeptide of the antibody can be covalently and site-specifically bound to a moiety of interest to provide an antibody conjugate. The disclosure also encompasses methods of production of such tagged Ig light chain polypeptides, fGly-modified Ig light chain polypeptides, and antibody conjugates, as well as methods of use of same.

Abstract: The present disclosure is directed to a pharmaceutical formulation intended for oral delivery of synthetic or natural poorly permeable molecules or salts/solvates thereof having a therapeutic activity. The pharmaceutical formulation can include a synthetic or natural poorly permeable molecule or salt or solvate thereof in an amount 0.01-10 wt. % of the total weight of the formulation; a lipophilic phase comprising triglycerides of fatty acids in an amount of 50-80 wt. % of the total weight of the formulation; and at least one lipophilic surfactant comprising partial esters of polyol and fatty acids in an amount of about 10-50 wt. % of the total weight of the formulation.

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: A method of drying soft capsules including steps of: a) supplying a flow of air to said soft capsules at a velocity of the air across the soft capsules of from about 0.15 m/s to about 13 m/s; b) increasing, over time, a drying temperature to which said soft capsules are exposed while ensuring that the drying temperature remains below a melting temperature of a capsule shell of the soft capsules; c) exposing said soft capsules to an initial relative humidity of from about 49% RH to about 79% RH; d) decreasing the relative humidity to which the soft capsules are exposed as the capsules dry until an equilibrium relative humidity of the soft capsules reaches a desired relative humidity; and e) exposing the soft capsules from step d) to a temperature of from 20-25° C. Also disclosed is a drying system for carrying out the method.

Abstract: A package for delivering a single-dose product includes a softgel capsule which is comprised of at least one gelling agent selected from protein-based gelling agents and polysaccharide-based gelling agents. The capsule shell includes one or more areas of reduced thickness that are preferentially ruptured by exertion of a compressive force on the softgel capsule to create an opening in the capsule shell through which the fill composition can be delivered by spraying or squeezing. A method for manufacturing the softgel capsule having one or more areas of reduced shell thickness is also described.

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: The present disclosure is directed to a pharmaceutical formulation intended for oral delivery of synthetic or natural poorly permeable molecules or salts/solvates thereof having a therapeutic activity. The pharmaceutical formulation can include a synthetic or natural poorly permeable molecule or salt or solvate thereof in an amount 0.01-10 wt. % of the total weight of the formulation; a lipophilic phase comprising triglycerides of fatty acids in an amount of 50-80 wt. % of the total weight of the formulation; and at least one lipophilic surfactant comprising partial esters of polyol and fatty acids in an amount of about 10-50 wt. % of the total weight of the formulation.

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: The present disclosure provides conjugate structures and hydrazinyl-substituted heteroaryl compounds used to produce these conjugates. The disclosure also encompasses methods of production of such conjugates and compounds, as well as methods of using the same.

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: 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: A method of filling containers with liquid product includes receiving a signal from at least one sensor corresponding to an amount of liquid product in a holding tank, the holding tank having an outlet for feeding the liquid product to a container filling apparatus; transferring liquid product from the outlet of the holding tank to an inlet of the container filling apparatus; and filling at least one container with the liquid product through at least one nozzle of the container filling apparatus for a predetermined fill time, wherein an amount of the liquid product dispensed during the predetermined fill time is based on a pressure at the outlet of the holding tank, wherein a head pressure in the holding tank is increased based on the signal from the sensor to control the pressure at the outlet of the holding tank as the liquid product is fed from the holding tank.

Abstract: The invention provides a die suitable for producing a multi-chamber softgel capsule. The die comprises a die pocket defined by a die pocket wall and a bottom surface. The die comprises one or more partitioning walls dividing the die pocket into two or more chambers The top of the land of the partitioning walls have a lowest point that is lower than the plane formed by the top of the land along the perimeter of the die pocket wall by a gap. A die roll comprising a plurality of the dies is also provided, as well as rotary-die encapsulation machine comprising the die roll.

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 shell capsule 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: A method of drying soft capsules including steps of: a) supplying a flow of air to said soft capsules at a velocity of the air across the soft capsules of from about 0.15 m/s to about 13 m/s; b) increasing, over time, a drying temperature to which said soft capsules are exposed while ensuring that the drying temperature remains below a melting temperature of a capsule shell of the soft capsules; c) exposing said soft capsules to an initial relative humidity of from about 49% RH to about 79% RH; d) decreasing the relative humidity to which the soft capsules are exposed as the capsules dry until an equilibrium relative humidity of the soft capsules reaches a desired relative humidity; and e) exposing the soft capsules from step d) to a temperature of from 20-25° C. Also disclosed is a drying system for carrying out the method.

Abstract: The invention provides a pump for dispensing a plurality of fluids at predetermined volumes to a common location and a method of using the pump to deliver such plurality of fluids. The pump comprises one or more first syringe units, each first syringe unit comprising a first plunger and a first chamber within which the first plunger slides. A first inlet channel is fluidly connected to the first chamber of each first syringe unit and configured to receive the first fluid. The pump also comprises one or more second syringe units, each second syringe unit comprising a second plunger and a second chamber within which the second plunger slides. A second inlet channel is fluidly connected to the second chamber of each second syringe unit and configured to receive the second fluid.

Abstract: A system for recovering gel-mass from a gel-mass-containing waste material. The system includes mangle rolls, a heated accumulator for receiving and melting the gel-mass-containing waste material to provide an oil phase and a non-oil phase; a pumping system; an optional mixer; and a control system.

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, tranquilizers, stimulants and narcotics.

Abstract: A process and system for recovering gel-mass from a gel-mass-containing waste material. The process comprises retrieving the gel-mass-containing waste material from an encapsulation process; melting the retrieved waste material to provide an oil phase and a non-oil phase; retrieving the non-oil phase to produce a recovered gel-mass; and recycling the recovered gel-mass for combination with fresh encapsulating material to provide a combined encapsulating material for use in encapsulating a same lot of the same product which was being encapsulated in the step that produced the gel-mass-containing waste material from which the gel-mass was obtained. The system comprises a heated accumulator for receiving and melting the gel-mass-containing waste material to provide an oil phase and a non-oil phase; a pumping system; an optional mixer; and a control system.