Patents Assigned to R. P. Scherer
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Patent number: 11980668Abstract: 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.Type: GrantFiled: October 23, 2019Date of Patent: May 14, 2024Assignee: R.P. Scherer Technologies, LLCInventors: David Rabuka, Junjie Liu, Stepan Chuprakov, Romas Alvydas Kudirka
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Patent number: 11980691Abstract: 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.Type: GrantFiled: March 15, 2019Date of Patent: May 14, 2024Assignee: R.P. Scherer Technologies, LLCInventors: Toshikazu Okayama, Miyako Takahashi, Takuma Fujii
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Patent number: 11970546Abstract: 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.Type: GrantFiled: July 30, 2021Date of Patent: April 30, 2024Assignee: R.P. SCHERER TECHNOLOGIES, LLCInventors: David Rabuka, Penelope M. Drake, Yun Cheol Kim, Robyn M. Barfield, Maxine Bauzon, Ayodele Ogunkoya
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Patent number: 11857637Abstract: 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.Type: GrantFiled: November 4, 2021Date of Patent: January 2, 2024Assignee: R.P. Scherer Technologies, LLCInventors: David Rabuka, Penelope M. Drake
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Publication number: 20230372252Abstract: 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.Type: ApplicationFiled: October 14, 2021Publication date: November 23, 2023Applicant: R.P. Scherer Technologies, LLCInventors: Qi Fang, Karunakar Sukuru
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Publication number: 20230351305Abstract: 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.Type: ApplicationFiled: April 28, 2023Publication date: November 2, 2023Applicant: R.P. Scherer Technologies, LLCInventors: Amin ABEDINI, Christin HOLLIS, Matthew DEFRESE
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Patent number: 11788066Abstract: 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.Type: GrantFiled: November 22, 2021Date of Patent: October 17, 2023Assignee: R.P. Scherer Technologies, LLCInventors: Yun Cheol Kim, Chao Bai Huang, David Rabuka
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Patent number: 11690789Abstract: 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.Type: GrantFiled: December 22, 2017Date of Patent: July 4, 2023Assignee: R.P. Scherer Technologies, LLCInventors: Shawn P. McKee, David G. Williams, Sr., Lester David Fulper
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Publication number: 20230165799Abstract: 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.Type: ApplicationFiled: December 5, 2022Publication date: June 1, 2023Applicants: R.P. Scherer Technologies, LLC, UNIVERSITY OF MISSISSIPPIInventors: Sampada Bhaskar UPADHYE, Ronald S. VLADYKA, Michael Andrew REPKA, Jun-Bom PARK, Roshan Vijay TIWARI, Hemlata Gunga PATIL, Joseph Thomas MOROTT, JR., Wenli LU
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Patent number: 11655492Abstract: 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.Type: GrantFiled: June 2, 2021Date of Patent: May 23, 2023Assignee: R.P. Scherer Technologies, LLCInventors: David Rabuka, Gregory W. deHart, Patrick Holder, Jeanne Baker
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Patent number: 11564989Abstract: 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.Type: GrantFiled: January 13, 2022Date of Patent: January 31, 2023Assignee: R.P. Scherer Technologies, LLCInventors: Stepan Chuprakov, Ayodele O. Ogunkoya, Penelope M. Drake
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Patent number: 11535811Abstract: 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.Type: GrantFiled: September 26, 2019Date of Patent: December 27, 2022Assignee: R.P. Scherer Technologies, LLCInventors: Lester David Fulper, Werner Stange, Norton Richard Hart, Shawn P. McKee, Neftali Tosado
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Patent number: 11529313Abstract: 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.Type: GrantFiled: July 22, 2020Date of Patent: December 20, 2022Assignees: R.P. Scherer Technologies, LLC, UNIVERSITY OF MISSISSIPPIInventors: Sampada Bhaskar Upadhye, Ronald S. Vladyka, Michael Andrew Repka, Jun-Bom Park, Roshan Vijay Tiwari, Hemlata Gunga Patil, Joseph Thomas Morott, Jr., Wenli Lu
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Publication number: 20220362160Abstract: 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.Type: ApplicationFiled: July 19, 2022Publication date: November 17, 2022Applicant: R.P. Scherer Technologies, LLCInventor: Simone Wengner
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Patent number: 11466096Abstract: Antibodies that include a sulfatase motif-containing tag in a constant region of an immunoglobulin (Ig) heavy chain polypeptide are disclosed. The sulfatase motif can be converted by a formylglycine-generating enzyme (FGE) to produce a formylglycine (fGly)-modified Ig heavy chain polypeptide. An fGly-modified Ig heavy 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 heavy chain polypeptides, fGly-modified Ig heavy chain polypeptides, and antibody conjugates, as well as methods of use of same.Type: GrantFiled: March 13, 2018Date of Patent: October 11, 2022Assignee: R.P. Scherer Technologies, LLCInventors: Yun Cheol Kim, Chao Bai Huang, Penelope M. Drake, David Rabuka
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Patent number: 11464747Abstract: 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.Type: GrantFiled: September 16, 2019Date of Patent: October 11, 2022Assignee: R.P. Scherer Technologies, LLCInventor: Simone Wengner
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Publication number: 20220249468Abstract: The present disclosure is directed to a pharmaceutical formulation intended for oral delivery of synthetic or natural poorly permeable calcitonin gene-related peptide (CGRP) inhibitors or salts/solvates thereof having a therapeutic activity. The pharmaceutical formulation can include a synthetic or natural poorly permeable CGRP inhibitors 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.Type: ApplicationFiled: April 10, 2020Publication date: August 11, 2022Applicants: R.P. Scherer Technologies, LLC, Biohaven Pharmaceutical Holding Company Ltd.Inventors: Vincent PLASSAT, Benoit HILBOLD, Aurélia GALUS, Thomas POINTEAUX, Julien MEISSONNIER, Gene M. DUBOWCHIK, Charles M. CONWAY
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Patent number: 11376334Abstract: 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.Type: GrantFiled: July 22, 2020Date of Patent: July 5, 2022Assignee: R.P. Scherer Technologies, LLCInventors: Stepan Chuprakov, Romas Alvydas Kudirka, Jesse M. McFarland, Albert W. Garafalo, David Rabuka
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Publication number: 20220175683Abstract: Softgels having improved stability of active pharmaceutical ingredients and methods of preparing the same are provided. In some embodiments, a softgel comprises a fill material composition and a softgel shell. In some embodiments, the fill material composition of the softgel comprises one or more active pharmaceutical ingredient (API); 2 to 15 wt. % povidone; 30 to 60 wt. % polyethylene glycol; and 0.5 to 5 wt. % propylene glycol, wherein the fill material composition has a pH of 3.75 or less. In some embodiments, the softgel shell is made from a softgel shell composition comprising an acidic component.Type: ApplicationFiled: March 11, 2020Publication date: June 9, 2022Applicant: R.P. SCHERER TECHNOLOGIES, LLCInventors: Douglas Keith DURHAM, Hitesh S. PATEL
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Publication number: 20220143188Abstract: 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.Type: ApplicationFiled: November 29, 2021Publication date: May 12, 2022Applicant: R.P. Scherer Technologies, LLCInventors: Vincent PLASSAT, Benoit HILBOLD, Aurélia GALUS, Thomas POINTEAUX, Julien MEISSONNIER