Patents Assigned to Baxalta GmbH
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Patent number: 10576160Abstract: The invention relates to materials and methods of conjugating a water soluble polymer to an oxidized carbohydrate moiety of a therapeutic protein comprising contacting the oxidized carbohydrate moiety with an activated water soluble polymer under conditions that allow conjugation. More specifically, the present invention relates to the aforementioned materials and methods wherein the water soluble polymer contains an active aminooxy group and wherein an oxime or hydrazone linkage is formed between the oxidized carbohydrate moiety and the active aminooxy group on the water soluble polymer, and wherein the conjugation is carried out in the presence of a nucleophilic catalyst.Type: GrantFiled: July 7, 2017Date of Patent: March 3, 2020Assignees: Baxalta Incorporated, Baxalta GmbHInventors: Juergen Siekmann, Stefan Haider, Hanspeter Rottensteiner, Peter Turecek
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Publication number: 20200018752Abstract: Provided herein are methods of measuring the qualitative and/or quantity attributes of gene therapy vector preparations. In certain embodiments, the gene therapy vector preparations are AAV preparations (e.g., AAV8). In certain embodiments the methods comprise determining the potency or dose of the AAV preparation using ELISA or ELISA in combination with CryoTEM.Type: ApplicationFiled: March 2, 2018Publication date: January 16, 2020Applicants: Baxalta Incorporated, Baxalta GmbHInventors: Marian BENDIK, Roman NECINA, Ernst BOEHM, Michael GRANINGER, Christian FIEDLER
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Publication number: 20200016515Abstract: This disclosure relates to a bottom section for being connected to an assembly for separating a solid component from a fluid. The assembly includes an inclined plate settler with at least one sedimentation channel for letting a solid component to be separated settle, said plate settler comprising a lower portion and an upper portion, wherein said at least one sedimentation channel extends from the lower portion to the upper portion. The bottom section is configured to be connected to the lower portion of the inclined plate settler. The bottom section comprises at least one inlet channel for feeding a fluid comprising the solid component to be separated to the plate settler, and at least one collection channel for collecting a settled solid component descending from the at least one sedimentation channel.Type: ApplicationFiled: June 18, 2019Publication date: January 16, 2020Applicants: Baxalta Incorporated, Baxalta GmbHInventors: Nikolaus HAMMERSCHMIDT, Alois JUNGBAUER, Hannah ENGELMAIER
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Patent number: 10527551Abstract: The present invention relates to a method of predicting a performance characteristic of a plant or yeast hydrolysate, wherein a plant or yeast hydrolysate sample is measured with 2D fluorescence spectroscopy in powder form. Said method comprises the steps for providing a model based on a predetermined value of a manufacturing parameter of interest. For this purpose a training set consisting of predetermined manufacturing parameter of interest (e.g volumetric productivity parameter, virus titer or cell number) and fluorescence spectroscopic data is used. The fluorescence spectroscopic data is correlated to the values of the manufacturing parameter of interest to obtain a calibration model/model parameters by applying multivariate data analysis. This calibration model is being used to predict the manufacturing parameter of interest for new samples dedicated for the manufacturing process.Type: GrantFiled: December 18, 2014Date of Patent: January 7, 2020Assignees: Baxalta Incorporated, Baxalta GmbHInventors: Leopold Grillberger, Renata Baldaszti-Juric, Wolfgang Langer, Manfred Reiter
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Publication number: 20190365835Abstract: Provided herein are methods of producing an adeno-associated virus (AAV) product, methods of purifying adeno-associated virus, and methods of purifying full AAV capsids from a concentrated AAV fraction comprising empty AAV capsids and full AAV capsids.Type: ApplicationFiled: November 3, 2017Publication date: December 5, 2019Applicants: BAXALTA INCORPORATED, BAXALTA GMBHInventors: Christian FIEDLER, Leopold GRILLBERGER, Meinhard HASSLACHER, Barbara KRAUS, Dominik MITTERGRADNEGGER, Stefan REUBERGER, Horst SCHAFHAUSER, Marian BENDIK
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Publication number: 20190336588Abstract: The disclosure provides compositions and methods for treating, ameliorating, and/or preventing a vaso-occlusive crisis (VOC) in a subject suffering from sickle cell disease (SCD). The disclosure also provides compositions and methods for treating, ameliorating, and/or preventing lung injury in a subject suffering from or at risk of suffering from acute lung injury (ALI) and/or acute respiratory distress syndrome (ARDS). The disclosure provides A Disintegrin And Metalloproteinase with Thrombospondin type 1 motif, member-13 (ADAMTS13) or a composition comprising ADAMTS13 for treating, ameliorating, and/or preventing the VOC, or for treating, ameliorating, and/or preventing lung injury in a subject suffering from or at risk of suffering from ALI and/or ARDS.Type: ApplicationFiled: August 4, 2017Publication date: November 7, 2019Applicants: BAXALTA INCORPORATED, BAXALTA GMBHInventors: Bruce EWENSTEIN, Brahm GOLDSTEIN, Bernhard MAJER, Paolo ROSSATO, Friedrich SCHEIFLINGER, Marietta TURECEK
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Publication number: 20190321542Abstract: A syringe stabilizing apparatus has a base and a syringe support. The syringe support is vertically disposed above the base, elevating a fluid-filled portion of an infusion set vertically above the base and orienting a delivery end of the fluid-filled portion upwardly relative to a horizontal plane to take advantage of a gravitational effect on a fluid during delivery of the fluid from the fluid-filled portion to a patient. The syringe support comprises a first retainer and a selectively actuated tube clamp. The first retainer has an opening in which a rigid portion of the infusion set is received and retained therein without further user intervention. The selectively actuated tube clamp is operatively aligned with the first retainer wherein a flexible tube extending from the rigid portion of the infusion set extends through the tube clamp.Type: ApplicationFiled: June 26, 2017Publication date: October 24, 2019Applicants: Baxalta Incorporated, Baxalta GmbHInventors: Scott Richard Ariagno, Angela Teresa Muriset, Daniel Edward Roush, Denise A. Alexander, Madeleine Clare Gibson, Gin-Fu Chen
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Patent number: 10413600Abstract: This invention relates to methods of subcutaneous administration of ADAMTS13 formulations to a treat a disease or condition associated with ADAMTS13 and VWF dysfunction. Furthermore, evidence of the unexpectedly high bioavailability of ADAMTS13 formulations administered subcutaneously is provided herein.Type: GrantFiled: February 22, 2017Date of Patent: September 17, 2019Assignees: Baxalta Incorporated, Baxalta GmbHInventors: Alexandra Nathalie Kopic, Werner Höllriegl, Barbara Plaimauer, Hanspeter Rottensteiner, Eva-Maria Muchitsch
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Patent number: 10414793Abstract: The invention relates to materials and methods of conjugating a water soluble polymer to an oxidized carbohydrate moiety of a therapeutic protein comprising contacting the oxidized carbohydrate moiety with an activated water soluble polymer under conditions that allow conjugation. More specifically, the present invention relates to the aforementioned materials and methods wherein the water soluble polymer contains an active aminooxy group and wherein an oxime or hydrazone linkage is formed between the oxidized carbohydrate moiety and the active aminooxy group on the water soluble polymer, and wherein the conjugation is carried out in the presence of a nucleophilic catalyst.Type: GrantFiled: September 30, 2016Date of Patent: September 17, 2019Assignees: Baxalta Incorporated, Baxalta GmbHInventors: Stefan Haider, Andreas Ivens, Hanspeter Rottensteiner, Juergen Siekmann, Peter Turecek, Oliver Zoechling
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Publication number: 20190271706Abstract: The present specification discloses methods of characterizing a population of particles using a particle analyzer. Particles may be characterized by size, absolute number, whether the particle is non-proteinaceous or proteinaceous, whether a proteinaceous particle has or lacks a certain physical property, or any combination thereof.Type: ApplicationFiled: March 11, 2019Publication date: September 5, 2019Applicants: Baxalta Incorporated, Baxalta GmbHInventors: Mantas Malisauskas, Christian Lubich, Thomas Prenninger, Birgit Reipert
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Publication number: 20190255126Abstract: Adeno-associated liquid and lyophilized pharmaceutical compositions are provided herein. In exemplary aspects, the pharmaceutical compositions comprise about 5 mM to about 25 mM L-histidine, about 0 mM to about 150 mM sodium chloride, about 0.001% (w/v) to about 0.01% (w/v) polysorbate 80 (PS80), and about 1% to about 10% (w/v) sucrose, trehalose, or combination thereof to AAV. In exemplary aspects, the pharmaceutical compositions further comprise glycine or mannitol. Methods of preparing a pharmaceutical composition comprising AAV, methods of treating a bleeding disorder in a subject, and methods of storing AAV compositions are also provided.Type: ApplicationFiled: November 3, 2017Publication date: August 22, 2019Applicants: BAXALTA INCORPORATED, BAXALTA GMBHInventors: Christian FIEDLER, Eva FRITSCHER, Meinhard HASSLACHER, Dominik MITTERGRADNEGGER, Tanvir TABISH
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Publication number: 20190247475Abstract: The present invention relates to formulations of ADAMTS13 with enhanced or desirable properties. As such, the invention provides liquid and lyophilized formulations of ADAMTS13 that are suitable for pharmaceutical administration. Among other aspects, the present invention also provides methods of treating various diseases and conditions related to VWF and/or ADAMTS13 dysfunction in a subject. Also provided herein are kits comprising ADAMTS13 formulations useful for the treatment of various diseases and conditions.Type: ApplicationFiled: February 14, 2019Publication date: August 15, 2019Applicants: BAXALTA INCORPORATED, BAXALTA GMBHInventors: Peter Matthiessen, Peter L. Turecek, Hans-Peter Schwarz
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Patent number: 10378004Abstract: The present invention relates to a two-step method for the purification of divalent cation binding proteins with high yield and high purity on anion exchange resin materials, to divalent cation binding proteins obtainable by said method, and to a kit comprising means for carrying out said method.Type: GrantFiled: October 12, 2012Date of Patent: August 13, 2019Assignees: Baxalta GmbH, Baxalta IncorporatedInventors: Artur Mitterer, Meinhard Hasslacher, Christian Fiedler
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Publication number: 20190231855Abstract: Disclosed herein are compositions and methods for improving hemostasis in the treatment of bleeding disorders and reversal of anticoagulant activity. Effective ratios of prothrombin (FII) and activated factor X (FXa) for the treatment of bleeding disorders that are as efficacious as FEIBA®, but require a lower concentration of FII are described herein.Type: ApplicationFiled: December 21, 2018Publication date: August 1, 2019Applicants: Baxalta Incorporated, Baxalta GmbHInventors: Michael Dockal, Sabine Knappe, Susanne Till, Peter Leopold Turecek, Friedrich Scheiflinger
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Patent number: 10350301Abstract: The invention relates to materials and methods of conjugating a water soluble polymer to an oxidized carbohydrate moiety of a blood coagulation protein comprising contacting the oxidized carbohydrate moiety with an activated water soluble polymer under conditions that allow conjugation. More specifically, the present invention relates to the aforementioned materials and methods wherein the water soluble polymer contains an active aminooxy group and wherein an oxime linkage is formed between the oxidized carbohydrate moiety and the active aminooxy group on the water soluble polymer. In one embodiment of the invention the conjugation is carried out in the presence of the nucleophilic catalyst aniline. In addition the generated oxime linkage can be stabilized by reduction with NaCNBH3 to form an alkoxyamine linkage.Type: GrantFiled: August 29, 2016Date of Patent: July 16, 2019Assignees: Baxalta Incorporated, Baxalta GmbHInventors: Juergen Siekmann, Stefan Haider, Hanspeter Rottensteiner, Peter Turecek
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Publication number: 20190194351Abstract: Provided herein are anti-Factor IX Padua binding constructs, e.g., antibodies and antigen-binding fragments thereof. Related polypeptides, conjugates and kits are also provided. The inventions may be used in methods of detecting Factor IX Padua in a sample.Type: ApplicationFiled: May 16, 2017Publication date: June 27, 2019Applicants: Baxalta Incorporated, Baxalta GmbHInventors: Dirk Voelkel, Robert Pachlinger, Hanspeter Rottensteiner, Alfred Weber, Andrea Engelmaier
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Publication number: 20190161746Abstract: This invention relates to a pharmaceutical composition having thrombolytic activity comprising ADAMTS13, and to methods for treating or preventing a disorder associated with the formation and/or the presence of one or more thrombus and to methods of disintegrating one or more thrombus in a patient in need thereof. Furthermore, the invention relates to the use of a pharmaceutically effective amount of ADAMTS13 for the preparation of a pharmaceutical composition for treating or preventing a disorder associated with the formation or the presence of one or more thrombus and for disintegrating one or more thrombus in a patient in need thereof.Type: ApplicationFiled: January 30, 2019Publication date: May 30, 2019Applicants: BAXALTA INCORPORATED, BAXALTA GMBH, CHILDREN'S MEDICAL CENTER CORPORATIONInventors: Denisa D. Wagner, Anil Kumar CHAUHAN, Friedrich SCHEIFLINGER, Barbara PLAIMAUER
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Patent number: 10301376Abstract: Provided are combinations, compositions and kits containing a immune globulin (IG) composition and a soluble hyaluronidase composition formulated for subcutaneous administration. Such products can be used in methods of treating IG-treatable diseases or conditions. Also provided are methods for subcutaneous administration of immune globulin whereby the dosing regimen is substantially the same as for intravenous administration of the same dosage for treatment of the same IG-treatable disease or condition.Type: GrantFiled: March 16, 2009Date of Patent: May 28, 2019Assignees: Baxalta GmbH, Baxalta IncorporatedInventors: Richard Schiff, Heinz Leibl
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Publication number: 20190145989Abstract: The invention generally relates to methods of measuring cleaved von Willebrand factor (VWF) fragments. More specifically, the invention relates to methods of measuring the ability of a disintegrin and metalloproteinase with a thrombospondin type 1 motif, member 13 (ADAMTS13) to cleave VWF in vivo. The invention also relates to methods of using various animal models which demonstrate ADAMTS13 activity similar to that of a human. The invention further relates to methods of measuring the cleavage products of rVWF in mammals, particularly in humans and in human plasma.Type: ApplicationFiled: January 16, 2019Publication date: May 16, 2019Applicants: Baxalta GmbH, Baxalta IncorporatedInventors: Katalin VARADI, Hanspeter ROTTENSTEINER, Peter TURECEK, Hans-Peter SCHWARZ, Jutta SCHREINER
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Patent number: D878763Type: GrantFiled: October 3, 2018Date of Patent: March 24, 2020Assignees: Baxalta GmbH, Baxalta IncorporatedInventors: Madeleine Clare Gibson, Seth Dale Jones, Daniel Edward Roush, Nicholas John Schill, Ron Theis, Denise A. Alexander