Abstract: The present disclosure provides, among other aspects, improved methods for the manufacture of Factor H compositions from plasma precipitation fractions. In some aspects, the methods include an improved process step for extracting Factor H from a plasma precipitate fraction with reduced co-extraction of amidolytic activities. In other aspects, the methods include a heat treatment step for reducing impurities, such as amidolytic enzymes, from a Factor H composition. In yet other aspects, the methods include improved anion exchange, heparin affinity, and/or mixed mode chromatographic enrichment of Factor H. In still other aspects, the improved methods include a combination of the individual improved process steps disclosed herein.
Type:
Grant
Filed:
March 14, 2014
Date of Patent:
January 22, 2019
Assignees:
Baxalta Incorporated, Baxalta GmbH
Inventors:
Ruth Madlener, Wolfgang Teschner, Hans-Peter Schwarz, Sonja Svatos, Azra Pljevljakovic, Lena Nitsch
Abstract: The present invention provides, among other aspects, methods and compositions for treating a central nervous system (CNS) disorder by delivering a therapeutically effective amount of a composition of pooled human immunoglobulin G (IgG) to the brain via intranasal administration of the composition directly to the olfactory epithelium of the nasal cavity. In particular, methods and compositions for treating Alzheimer's disease are provided.
Type:
Grant
Filed:
October 26, 2016
Date of Patent:
December 4, 2018
Assignees:
Baxalta Incorporated, Baxalta GmbH
Inventors:
William H. Frey, Leah Ranae Bresin Hanson, Sharon Pokropinski, Francisco M. Rausa
Abstract: The present invention relates to animal protein-free cell culture media comprising polyamines and a plant- and/or yeast-derived hydrolysate. The invention also relates to animal protein-free culturing processes, wherein cells can be cultivated, propagated and passaged without adding supplementary animal proteins in the culture medium. These processes are useful in cultivating cells, such as recombinant cells or cells infected with a virus, and for producing biological products by cell culture processes.
Type:
Grant
Filed:
September 22, 2017
Date of Patent:
November 27, 2018
Assignees:
Baxalta Gmbh, Baxalta Incorporated
Inventors:
Leopold Grillberger, Manfred Reiter, Wolfgang Mundt, Friedrich Dorner
Abstract: The invention provides peptides, including peptides that bind and, optionally, inhibit Protein S, and compositions thereof. The peptides may be used to, e.g., inhibit Protein S activity, enhance thrombin formation in a subject, increase blood clot formation in a subject, treat a blood coagulation disorder in a subject, purify Protein S, and identify a Protein S binding compound.
Type:
Grant
Filed:
August 19, 2016
Date of Patent:
November 13, 2018
Assignees:
BAXALTA INCORPORATED, BAXALTA GMBH
Inventors:
Michael Dockal, Thomas Polakowski, Frank Osterkamp, Rudolf Hartmann, Matthias Paschke, Bettina Hartlieb, Friedrich Scheiflinger
Abstract: The present invention relates to a new and improved method for preparing a highly concentrated immunoglobulin composition from pooled plasma for subcutaneous injection. A composition comprising 20% or more immunoglobulin suitable for subcutaneous use is also described.
Type:
Grant
Filed:
September 16, 2015
Date of Patent:
November 13, 2018
Assignees:
Baxalta Incorporated, Baxalta GmbH
Inventors:
Wolfgang Teschner, Harald Arno Butterweck, Azra Pljevljakovic, Theresa Friederike Bauer, Bernhard Koelbl, Hans-Peter Schwarz, Nebojsa Nikolic, Gerhard Poelsler, Johanna Kindermann
Abstract: Among other aspects, the present invention relates to cell culture conditions for producing high molecular weight vWF, in particular, highly multimericWF with a high specific activity and ADAMTS13 with a high specific activity. The cell culture conditions of the present invention can include, for example, a cell culture medium with an increased copper concentration and/or cell culture supernatant with a low ammonium (NH4+) concentration. The present invention also provides methods for cultivating cells in the cell culture conditions to express high molecular weight vWF and rA13 having high specific activities.
Type:
Grant
Filed:
May 9, 2017
Date of Patent:
October 16, 2018
Assignees:
Baxalta Incorporated, Baxalta GmbH
Inventors:
Leopold Grillberger, Manfred Reiter, Daniel Fleischanderl, Gregor Bramberger
Abstract: The present invention provides culture mediums that are useful for the expression of ADAMTS proteins, such as ADAMTS13. Methods for the expression and purification of ADAMTS proteins are also provided. In some embodiments, the mediums and methods of the invention are useful for the expression of ADAMTS proteins having high specific activities. Also provided are ADAMTS, e.g., ADAMTS13, protein compositions with high specific activities, which are expressed and purified according to the methods provided herein.
Type:
Grant
Filed:
August 9, 2016
Date of Patent:
September 11, 2018
Assignees:
Baxalta Incorporated, Baxalta GmbH
Inventors:
Leopold Grillberger, Alexandra Spenger, Meinhard Hasslacher, Rana Grillberger, Manfred Reiter
Abstract: The present invention is in the field of hemophilia therapy. It relates to a new variant of antihemophilic factor VIII having increased specific activity in comparison to known factor VIII products.
Abstract: 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:
Application
Filed:
February 28, 2018
Publication date:
July 26, 2018
Applicants:
BAXALTA INCORPORATED, BAXALTA GMBH
Inventors:
Peter Matthiessen, Peter L. Turecek, Hans-Peter Schwarz
Abstract: The invention provides peptides that bind Tissue Factor Pathway Inhibitor (TFPI), including TFPI-inhibitory peptides, and compositions thereof. Peptide complexes also are provided. The peptides may be used to inhibit a TFPI, enhance thrombin formation in a clotting factor-deficient subject, increase blood clot formation in a subject, treat a blood coagulation disorder in a subject, purify TFPI, and identify a TFPI-binding compound.
Type:
Application
Filed:
November 16, 2017
Publication date:
June 7, 2018
Applicants:
Baxalta GmbH, Baxalta Incorporated
Inventors:
Michael DOCKAL, Rudolf HARTMANN, Friedrich SCHEIFLINGER, Frank OSTERKAMP, Thomas POLAKOWSKI, Ulrich REINEKE
Abstract: A medium is described for the protein-free and serum-free cultivation of cells, especially mammalian cells, whereby the medium contains a proportion of soy hydrolysate.
Type:
Grant
Filed:
August 12, 2016
Date of Patent:
May 29, 2018
Assignees:
Baxalta Incorporated, Baxalta GmbH
Inventors:
Manfred Reiter, Wolfgang Mundt, Friedrich Dorner, Leopold Grillberger, Artur Mitterer
Abstract: The present invention pertains to the recognition that a specific oxMIF form of MIF is useful as a diagnostic marker in (MIF-related) diseases, in particular for example monitoring of disease progression. The present invention also pertains to the respective use of a diagnostic kit and a respective diagnostic assay and pertains to advantageous respective antibodies.
Type:
Grant
Filed:
October 4, 2012
Date of Patent:
May 1, 2018
Assignees:
Baxalta Incorporated, Baxalta GmbH
Inventors:
Michael Thiele, Randolf J. Kerschbaumer, Dirk Voelkel, Patrice Douillard, Friedrich Scheiflinger
Abstract: Provided herein are methods for recanalization of occluded blood vessels in a subject having an infarction. The method includes a step of administering to the subject a therapeutically effective amount of isolated ADAMTS13 protein at particular dosages and ranges of times after detection of the infarction. As described herein, ADAMTS13 advantageously recanalizes occluded blood vessels and reduces infarction size, even when administered a prolonged period after stable occlusion. Accordingly, such methods and compositions are useful for the treatment of infractions caused by blood vessel occlusion.
Abstract: 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:
Grant
Filed:
January 6, 2017
Date of Patent:
April 10, 2018
Assignees:
Baxalta Incorporated, Baxalta GmbH
Inventors:
Peter Matthiessen, Peter L. Turecek, Hans-Peter Schwarz
Abstract: The invention provides peptides that bind Tissue Factor Pathway Inhibitor (TFPI), including TFPI-inhibitory peptides, and compositions thereof. The peptides may be used to inhibit a TFPI, enhance thrombin formation in a clotting factor-deficient subject, increase blood clot formation in a subject, and/or treat a blood coagulation disorder in a subject.
Type:
Application
Filed:
August 18, 2017
Publication date:
March 15, 2018
Applicants:
Baxalta GmbH, Baxalta Incorporated
Inventors:
Michael DOCKAL, Hartmut Ehrlich, Friedrich Scheiflinger, Ulf Reimer, Ulrich Reineke, Thomas Polakowski, Eberhard Schneider
Abstract: The present invention provides, among other aspects, methods for the manufacture of plasma-derived immunoglobulin G compositions highly enriched for anti-brain disease related protein antibodies (e.g., anti-A?, anti-RAGE, and anti-?-synuclein antibodies). Advantageously, the methods provided do not affect the manufacturing processes or capabilities for producing plasma-derived IgG therapeutics. Plasma-derived IgG compositions that are highly enriched for anti-brain disease related protein antibodies (e.g., anti-A?, anti-RAGE, and anti-?-synuclein antibodies), as also provided here. Methods for the treatment of brain diseases and disorders by administration of plasma-derived IgG compositions highly enriched for anti-brain disease related protein antibodies (e.g., anti-A?, anti-RAGE, and anti-?-synuclein antibodies), are also provided.
Type:
Grant
Filed:
March 14, 2014
Date of Patent:
February 20, 2018
Assignees:
Baxalta Incorporated, Baxalta GmbH
Inventors:
Lucia Gnauer, Harald Arno Butterweck, Theresa Bauer, Alfred Weber, Wolfgang Teschner, Hans-Peter Schwarz
Abstract: Disclosed are a stable recombinant cell clones which are stable in serum- and protein-free medium for at least 40 generations, a biomass obtained by multiplying the stable cell clone under serum- and protein-free culturing conditions, and a method of preparing recombinant proteins by means of the biomass. Furthermore, the invention relates to a method of recovering stable recombinant cell clones.
Type:
Grant
Filed:
December 11, 2014
Date of Patent:
March 6, 2018
Assignees:
Baxalta Incorporated, Baxalta GmbH
Inventors:
Manfred Reiter, Wolfgang Mundt, Friedrich Dorner
Abstract: Disclosed are a stable recombinant cell clones which are stable in serum- and protein-free medium for at least 40 generations, a biomass obtained by multiplying the stable cell clone under serum- and protein-free culturing conditions, and a method of preparing recombinant proteins by means of the biomass. Furthermore, the invention relates to a method of recovering stable recombinant cell clones.
Type:
Grant
Filed:
July 6, 2016
Date of Patent:
May 22, 2018
Assignees:
Baxalta Incorporated, Baxalta GmbH
Inventors:
Manfred Reiter, Wolfgang Mundt, Friedrich Dorner
Abstract: Disclosed are a stable recombinant cell clones which are stable in serum- and protein-free medium for at least 40 generations, a biomass obtained by multiplying the stable cell clone under serum- and protein-free culturing conditions, and a method of preparing recombinant proteins by means of the biomass. Furthermore, the invention relates to a method of recovering stable recombinant cell clones.
Type:
Grant
Filed:
July 6, 2016
Date of Patent:
June 19, 2018
Assignees:
Baxalta Incorporated, Baxalta GmbH
Inventors:
Manfred Reiter, Wolfgang Mundt, Friedrich Dorner