Patents by Inventor Ulla Grauschopf
Ulla Grauschopf has filed for patents to protect the following inventions. This listing includes patent applications that are pending as well as patents that have already been granted by the United States Patent and Trademark Office (USPTO).
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Publication number: 20230310681Abstract: A method of preparing a prefilled syringe (1), comprises (i) obtaining a syringe barrel (11) having an open end (111) and a tip (112) with an orifice (113) essentially opposite to the open end (111), and a needle adaptor cap (12) assembled on the tip (112) of the syringe barrel, wherein the needle adaptor cap (12) has a rubber element (121) tightly sealing the orifice (113) of the tip (112) of the syringe barrel (11) and the syringe barrel (11) together with the needle adaptor cap (12) assembled on the tip (112) of the syringe barrel (11) is sterilized by a first sterilizing comprising a main step of exposing the syringe barrel (11) together with the needle adaptor cap (12) assembled on the tip (112) of the syringe barrel (11) to ethylene oxide for about 5 hours to about 60 hours at a relative humidity of about 40% to about 100% and at a temperature of about 30° C. to about 60° C.Type: ApplicationFiled: June 6, 2023Publication date: October 5, 2023Inventors: Markus HEMMINGER, Ulla GRAUSCHOPF, Frank BAMBERG, Mayumi BOWEN, Robert MÜLLER, Flora FELSOVALYI, Denny CHRISTENSEN
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Patent number: 11738106Abstract: A method of preparing a prefilled syringe is disclosed that includes obtaining a syringe barrel and a needle adaptor cap assembled on the tip of the syringe barrel, wherein the needle adaptor cap has a rubber element tightly sealing the orifice of the tip of the syringe barrel and the syringe barrel together with the needle adaptor cap assembled on the tip of the syringe barrel is sterilized by a first sterilizing. Filling a drug substance into an interior of the syringe barrel and sealing the interior of the syringe barrel. Packaging the syringe barrel with a rubber stopper sealing the interior thereof and the needle adaptor cap assembled on the tip of the syringe barrel. Providing a second external surface sterilizing of the packaged syringe barrel with the rubber stopper sealing the interior thereof and the needle adaptor cap assembled on the tip of the syringe barrel.Type: GrantFiled: September 28, 2018Date of Patent: August 29, 2023Assignees: F. HOFFMANN-LA ROCHE AG, GENENTECH, INC.Inventors: Markus Hemminger, Ulla Grauschopf, Frank Bamberg, Mayumi Bowen, Robert Müller, Flora Felsovalyi, Denny Christensen
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Publication number: 20210353753Abstract: The present invention relates to a highly concentrated, stable pharmaceutical formulation of a pharmaceutically active anti-HER2 antibody, such as e.g. Trastuzumab (HERCEPTIN™), Pertuzumab or T-DM1, or a mixture of such antibody molecules for subcutaneous injection. In particular, the present invention relates to formulations comprising, in addition to a suitable amount of the anti-HER2 antibody, an effective amount of at least one hyaluronidase enzyme as a combined formulation or for use in form of a co-formulation. The formulations comprise additionally at least one buffering agent, such as e.g. a histidine buffer, a stabilizer or a mixture of two or more stabilizers (e.g. a saccharide, such as e.g. ?,?-trehalose dihydrate or sucrose, and optionally methionine as a second stabilizer), a nonionic surfactant and an effective amount of at least one hyaluronidase enzyme. Methods for preparing such formulations and their uses thereof are also provided.Type: ApplicationFiled: July 27, 2021Publication date: November 18, 2021Applicant: Genentech, IncInventors: Michael Adler, Ulla Grauschopf, Hanns-Christian Mahler, Oliver Boris Stauch
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Publication number: 20200297919Abstract: A method of preparing a prefilled syringe is disclosed that includes obtaining a syringe barrel and a needle adaptor cap assembled on the tip of the syringe barrel, wherein the needle adaptor cap has a rubber element tightly sealing the orifice of the tip of the syringe barrel and the syringe barrel together with the needle adaptor cap assembled on the tip of the syringe barrel is sterilized by a first sterilizing. Filling a drug substance into an interior of the syringe barrel and sealing the interior of the syringe barrel. Packaging the syringe barrel with a rubber stopper sealing the interior thereof and the needle adaptor cap assembled on the tip of the syringe barrel. Providing a second external surface sterilizing of the packaged syringe barrel with the rubber stopper sealing the interior thereof and the needle adaptor cap assembled on the tip of the syringe barrel.Type: ApplicationFiled: September 28, 2018Publication date: September 24, 2020Inventors: Markus HEMMINGER, Ulla GRAUSCHOPF, Frank BAMBERG, Mayumi BOWEN, Robert MÜLLER, Flora FELSOVALYI, Denny CHRISTENSEN
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Publication number: 20200282130Abstract: A method of preparing a prefilled syringe is disclosed that includes obtaining a syringe barrel and a needle adaptor cap assembled on the tip of the syringe barrel, wherein the needle adaptor cap has a rubber element tightly sealing the orifice of the tip of the syringe barrel and the syringe barrel together with the needle adaptor cap assembled on the tip of the syringe barrel is sterilized by a first sterilizing. Filling a drug substance into an interior of the syringe barrel and sealing the interior of the syringe barrel. Packaging the syringe barrel with a rubber stopper sealing the interior thereof and the needle adaptor cap assembled on the tip of the syringe barrel. Providing a second external surface sterilizing of the packaged syringe barrel with the rubber stopper sealing the interior thereof and the needle adaptor cap assembled on the tip of the syringe barrel.Type: ApplicationFiled: September 28, 2018Publication date: September 10, 2020Inventors: Markus HEMMINGER, Ulla GRAUSCHOPF, Frank BAMBERG, Mayumi BOWEN, Robert MÜLLER, Flora FELSOVALYI, Denny CHRISTENSEN
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Publication number: 20180228895Abstract: The present invention relates to a highly concentrated, stable pharmaceutical formulation of a pharmaceutically active anti-HER2 antibody, such as e.g. Trastuzumab (HERCEPTIN™), Pertuzumab or T-DM1, or a mixture of such antibody molecules for subcutaneous injection. In particular, the present invention relates to formulations comprising, in addition to a suitable amount of the anti-HER2 antibody, an effective amount of at least one hyaluronidase enzyme as a combined formulation or for use in form of a co-formulation. The formulations comprise additionally at least one buffering agent, such as e.g. a histidine buffer, a stabilizer or a mixture of two or more stabilizers (e.g. a saccharide, such as e.g. ?,?-trehalose dihydrate or sucrose, and optionally methionine as a second stabilizer), a nonionic surfactant and an effective amount of at least one hyaluronidase enzyme. Methods for preparing such formulations and their uses thereof are also provided.Type: ApplicationFiled: April 10, 2018Publication date: August 16, 2018Applicant: Genentech, Inc.Inventors: Michael Adler, Ulla Grauschopf, Hanns-Christian Mahler, Oliver Boris Stauch
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Patent number: 9968676Abstract: The present invention relates to a highly concentrated, stable pharmaceutical formulation of a pharmaceutically active anti-HER2 antibody, such as e.g. Trastuzumab (HERCEPTIN™), Pertuzumab or T-DM1, or a mixture of such antibody molecules for subcutaneous injection. In particular, the present invention relates to formulations comprising, in addition to a suitable amount of the anti-HER2 antibody, an effective amount of at least one hyaluronidase enzyme as a combined formulation or for use in form of a co-formulation. The formulations comprise additionally at least one buffering agent, such as e.g. a histidine buffer, a stabilizer or a mixture of two or more stabilizers (e.g. a saccharide, such as e.g. ?,?-trehalose dihydrate or sucrose, and optionally methionine as a second stabilizer), a nonionic surfactant and an effective amount of at least one hyaluronidase enzyme. Methods for preparing such formulations and their uses thereof are also provided.Type: GrantFiled: February 25, 2016Date of Patent: May 15, 2018Assignee: Genentech, Inc.Inventors: Michael Adler, Ulla Grauschopf, Hanns-Christian Mahler, Oliver Boris Stauch
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Publication number: 20170360891Abstract: The present invention provides a stable, isotonic, aqueous solution formulation comprising: (i) 0.1-0.5 mg/mL alpha-type interferon, preferably pegylated alpha-type interferon; (ii) 20 mM Acetate buffer system to maintain a pH of 6.0±0.5; (iii) 5-20 mM L-methionine; (iv) 120-150 mM sodium chloride; (v) 0.01-0.07 percent by weight of a surfactant effective to stabilize the alpha-type interferon, preferably pegylated alpha-type interferon against loss of its activity and (vi) an amount of water for injection sufficient to prepare a solution of the above-listed ingredients.Type: ApplicationFiled: March 23, 2017Publication date: December 21, 2017Applicant: Hoffmann-La Roche Inc.Inventors: Ulla Grauschopf, Michael Adler, Hanns-Christian Mahler, Felix Heise, Susanne Baroth
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Publication number: 20160166689Abstract: The present invention relates to a highly concentrated, stable pharmaceutical formulation of a pharmaceutically active anti-HER2 antibody, such as e.g. Trastuzumab (HERCEPTIN™), Pertuzumab or T-DM1, or a mixture of such antibody molecules for subcutaneous injection. In particular, the present invention relates to formulations comprising, in addition to a suitable amount of the anti-HER2 antibody, an effective amount of at least one hyaluronidase enzyme as a combined formulation or for use in form of a co-formulation. The formulations comprise additionally at least one buffering agent, such as e.g. a histidine buffer, a stabilizer or a mixture of two or more stabilizers (e.g. a saccharide, such as e.g. ?,?-trehalose dihydrate or sucrose, and optionally methionine as a second stabilizer), a nonionic surfactant and an effective amount of at least one hyaluronidase enzyme. Methods for preparing such formulations and their uses thereof are also provided.Type: ApplicationFiled: February 25, 2016Publication date: June 16, 2016Applicant: Genentech, Inc.Inventors: Michael Adler, Ulla Grauschopf, Hanns-Christian Mahler, Oliver Boris Stauch
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Patent number: 9345661Abstract: The present invention relates to a highly concentrated, stable pharmaceutical formulation of a pharmaceutically active anti-HER2 antibody, such as e.g. Trastuzumab (HERCEPTIN™), Pertuzumab or T-DM1, or a mixture of such antibody molecules for subcutaneous injection. In particular, the present invention relates to formulations comprising, in addition to a suitable amount of the anti-HER2 antibody, an effective amount of at least one hyaluronidase enzyme as a combined formulation or for use in form of a co-formulation. The formulations comprise additionally at least one buffering agent, such as e.g. a histidine buffer, a stabilizer or a mixture of two or more stabilizers (e.g. a saccharide, such as e.g. ?,?-trehalose dihydrate or sucrose, and optionally methionine as a second stabilizer), a nonionic surfactant and an effective amount of at least one hyaluronidase enzyme. Methods for preparing such formulations and their uses thereof are also provided.Type: GrantFiled: July 27, 2010Date of Patent: May 24, 2016Assignee: Genentech, Inc.Inventors: Michael Adler, Ulla Grauschopf, Hanns-Christian Mahler, Oliver Boris Stauch
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Publication number: 20140093512Abstract: This invention relates to a pharmaceutical formulation of an antibody against P-Selectin, a process for the preparation of the formulation and uses of the formulation.Type: ApplicationFiled: September 19, 2013Publication date: April 3, 2014Applicant: Hoffmann-La Roche Inc.Inventors: Ulla Grauschopf, Hanns-Christian Mahler, Oliver Boris Stauch
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Publication number: 20130251725Abstract: The present invention relates to a stable liquid pharmaceutical formulation comprising 40 mg/ml to 200 mg/ml of an antibody against P-selectin; 0.01% to 0.1% of a poloxamer; 5 mM to 100 mM of a buffer; and 100 mM to 500 mM of at least one stabilizer; at a pH in the range from 4.5 to 7.0.Type: ApplicationFiled: March 7, 2013Publication date: September 26, 2013Applicant: HOFFMANN-LA ROCHE INC.Inventors: Ulla Grauschopf, Michael Adler, Hanns-Christian Mahler
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Publication number: 20120321638Abstract: This invention relates to a pharmaceutical formulation of an antibody against P-Selectin, a process for the preparation of the formulation and uses of the formulation.Type: ApplicationFiled: July 30, 2012Publication date: December 20, 2012Inventors: Ulla Grauschopf, Hanns-Christian Mahler, Oliver Boris Stauch
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Publication number: 20110158987Abstract: This invention relates to a pharmaceutical formulation of an antibody against Epidermal Growth Factor Receptor (EGFR), a process for the preparation and uses of the formulation.Type: ApplicationFiled: December 23, 2010Publication date: June 30, 2011Inventors: Michael Adler, Ulla Grauschopf, Hanns-Christian Mahler
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Publication number: 20110044977Abstract: The present invention relates to a highly concentrated, stable pharmaceutical formulation of a pharmaceutically active anti-HER2 antibody, such as e.g. Trastuzumab (HERCEPTIN™), Pertuzumab or T-DM1, or a mixture of such antibody molecules for subcutaneous injection. In particular, the present invention relates to formulations comprising, in addition to a suitable amount of the anti-HER2 antibody, an effective amount of at least one hyaluronidase enzyme as a combined formulation or for use in form of a co-formulation. The formulations comprise additionally at least one buffering agent, such as e.g. a histidine buffer, a stabilizer or a mixture of two or more stabilizers (e.g. a saccharide, such as e.g. ?,?-trehalose dihydrate or sucrose, and optionally methionine as a second stabilizer), a nonionic surfactant and an effective amount of at least one hyaluronidase enzyme. Methods for preparing such formulations and their uses thereof are also provided.Type: ApplicationFiled: July 27, 2010Publication date: February 24, 2011Applicant: Genentech, Inc.Inventors: Michael Adler, Ulla Grauschopf, Hanns-Christian Mahler, Oliver Boris Stauch
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Publication number: 20100074903Abstract: This invention relates to a pharmaceutical formulation of an antibody against P-Selectin, a process for the preparation of the formulation and uses of the formulation.Type: ApplicationFiled: September 15, 2009Publication date: March 25, 2010Inventors: Ulla Grauschopf, Hanns-Christian Mahler, Oliver Boris Stauch