Patents by Inventor Hanns-Christian Mahler

Hanns-Christian Mahler 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).

  • Publication number: 20210096130
    Abstract: The present disclosure provides compositions, methods, and kits for detecting lipolytic activity. In some embodiments, the composition comprises an aqueous assay sample and an organic solvent, wherein the organic solvent comprises 4-methylumbelliferyl oleate (4MuO). Also provided herein are methods for determining the stability of a protein preparation.
    Type: Application
    Filed: September 9, 2020
    Publication date: April 1, 2021
    Inventors: Hanns-Christian MAHLER, Filip FEDOROWICZ, Michael JAHN, Andreas ZERR, Atanas KOULOV
  • Publication number: 20210054092
    Abstract: The present invention relates to a highly concentrated, stable pharmaceutical formulation of a pharmaceutically active anti-CD20 antibody, such as e.g. Rituximab, Ocrelizumab, or HuMab<CD20>, 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-CD20 antibody, an effective amount of at least one hyaluronidase enzyme as a combined formulation or for use in form of a co-formulation. The said 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: Application
    Filed: July 30, 2020
    Publication date: February 25, 2021
    Applicant: Genentech, Inc.
    Inventors: Michael Adler, Hanns-Christian Mahler, Oliver Boris Stauch
  • Patent number: 10928236
    Abstract: A peristaltic dosing device for providing dosages of a fluid at a volume of less than one milliliter comprises: a flexible tube, a counter pressure element, a plurality of actors and a drive. The flexible tube is essentially straightly arranged along the counter pressure element thereby forming a longitudinal axis. The actors arranged parallel to each other along the longitudinal axis. They are moveable by the drive in relation to the flexible tube. The flexible tube is compressible between the actors and the counter pressure element by moving the actors. Each of the actors is independently and linearly moveable by the drive along an actuation axis essentially perpendicular to the longitudinal axis of the flexible tube from a home position in which the flexible tube is least compressed to an end position in which the flexible tube is compressed and sealed between the respective actor and the counter pressure element.
    Type: Grant
    Filed: July 23, 2015
    Date of Patent: February 23, 2021
    Assignee: HOFFMANN-LA ROCHE INC.
    Inventors: Michael Adler, Karoline Bechtold-Peters, Adeline Boillon, Anke Dorn, Joerg Luemkemann, Denis Luthringer, Hanns-Christian Mahler, Alexander Meyer
  • Patent number: 10895514
    Abstract: Devices and methods for container closure integrity testing by leak testing, in particular of pharmaceutical containers, which are composed of two parts, the container itself, which shows an opening, and a closure system that is used to close this opening of the container, such as a lid; and their application in quality control.
    Type: Grant
    Filed: September 13, 2018
    Date of Patent: January 19, 2021
    Assignee: Lonza Ltd
    Inventors: Roman Mathaes, Anja Matter, Sarah Pelaez, Hanns-Christian Mahler, Atanas Koulov, Benjamin Zucol, Martin Vogt, Lorenz Hochwallner
  • Publication number: 20200385152
    Abstract: A device for closing a chamber of a container having an opening for accessing the chamber comprises a plunger, a plunger seat, a container carrier and a spacer. The plunger seat releasably holds the plunger in a predefined alignment. The container carrier is arranged to be connected to the container in a predefined position and alignment in relation to the opening of the container. The spacer is arranged to position and align the plunger seat adjacent to and distant from the container carrier such that the opening of the container is open when the container is connected to the container carrier.
    Type: Application
    Filed: August 24, 2020
    Publication date: December 10, 2020
    Inventors: Tobias WERK, Jörg LÜMKEMANN, Hanns-Christian MAHLER, Tom KISSLING
  • Patent number: 10801913
    Abstract: The present invention relates to a method and a device for determining the robustness and tolerance of pre-filled containers, in particular pre-filled syringes (PFS) against accidental movement of flexible parts, specifically tip cap and/or plunger movement due to external influences by measuring the leakage rate of a test medium in correlation to a movement of a flexible parts.
    Type: Grant
    Filed: September 13, 2018
    Date of Patent: October 13, 2020
    Assignee: Lonza Ltd
    Inventors: Roman Mathaes, Anja Matter, Sarah Pelaez, Hanns-Christian Mahler, Atanas Koulov
  • Patent number: 10773838
    Abstract: A device (1) for closing a chamber of a container having an opening for accessing the chamber comprises a plunger, a plunger seat (11), a container carrier (13) and a spacer (12). The plunger seat (11) releasably holds the plunger in a predefined alignment. The container carrier (13) is arranged to be connected to the container in a predefined position and alignment in relation to the opening of the container. The spacer (12) is arranged to position and align the plunger seat (11) adjacent to and distant from the container carrier (13) such that the opening of the container is open when the container is connected to the container carrier (13).
    Type: Grant
    Filed: December 4, 2015
    Date of Patent: September 15, 2020
    Assignee: HOFFMANN-LA ROCHE INC.
    Inventors: Tobias Werk, Jörg Lümkemann, Hanns-Christian Mahler, Tom Kissling
  • Publication number: 20200276394
    Abstract: The present invention relates to a method and a device for determining the robustness and tolerance of pre-filled containers, in particular pre-filled syringes (PFS) against accidental movement of flexible parts, specifically tip cap and/or plunger movement due to external influences by measuring the leakage rate of a test medium in correlation to a movement of a flexible parts.
    Type: Application
    Filed: September 13, 2018
    Publication date: September 3, 2020
    Inventors: Roman Mathaes, Anja Matter, Sarah Pelaez, Hanns-Christian Mahler, Atanas Koulov
  • Publication number: 20200271541
    Abstract: The invention discloses devices and methods for container closure integrity testing by leak testing, in particular of pharmaceutical containers, which are composed of two parts, the container itself, which shows an opening, and a closure system that is used to close this opening of the container, such as a lid; and their application in quality control.
    Type: Application
    Filed: September 13, 2018
    Publication date: August 27, 2020
    Inventors: Roman Mathaes, Anja Matter, Sarah Pelaez, Hanns-Christian Mahler, Atanas Koulov, Benjamin Zucol, Martin Vogt, Lorenz Hochwallner
  • Patent number: 10752696
    Abstract: The present invention relates to a highly concentrated, stable pharmaceutical formulation of a pharmaceutically active anti-CD20 antibody, such as e.g. Rituximab, Ocrelizumab, or HuMab<CD20>, 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-CD20 antibody, an effective amount of at least one hyaluronidase enzyme as a combined formulation or for use in form of a co-formulation. The said 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: Grant
    Filed: June 24, 2019
    Date of Patent: August 25, 2020
    Assignee: GENENTECH, INC.
    Inventors: Michael Adler, Hanns-Christian Mahler, Oliver Boris Stauch
  • Patent number: 10746644
    Abstract: The invention refers to an in vitro method and apparatus for analysing the behaviour of substances in simulated physiological environment. The method comprises the steps of providing a first fluid, a gel matrix and a second fluid, separating the first fluid and the gel matrix by at least one first semi-permeable membrane and separating the gel matrix and the second fluid by at least one second semi-permeable membrane. The method further comprises the steps of injecting a substance into the first fluid, letting the substance migrate from the first fluid through the at least one first semi-permeable membrane, through the gel matrix, through the at least one second semi-permeable membrane and into the second fluid, and determining clearance of the substance from the first fluid.
    Type: Grant
    Filed: September 20, 2019
    Date of Patent: August 18, 2020
    Assignee: Hoffmann-La Roche Inc.
    Inventors: Hanns-Christian Mahler, Dhananjay Jagdish Jere, Sulabh Patel
  • Patent number: 10696431
    Abstract: A method for providing a dried solid product containing an active pharmaceutical ingredient is disclosed and includes providing a primary packaging container, providing a drying cartridge different from the primary packaging container, the drying cartridge made of a material adapted to hold a liquid product to be dried, wherein the liquid product contains an active pharmaceutical ingredient and the drying cartridge is made of a material having a thermal conductivity higher than the thermal conductivity of glass. The method also includes filling the liquid product into the drying cartridge, drying the liquid product in the drying cartridge to form a dried solid product containing the active pharmaceutical ingredient, transferring the dried solid product into the primary packaging container.
    Type: Grant
    Filed: October 14, 2015
    Date of Patent: June 30, 2020
    Assignee: Hoffmann-La Roche Inc.
    Inventors: Jörg Lümkemann, Hanns-Christian Mahler, Sebastian Schneider, Jörg Völkle, Tobias Werk
  • Publication number: 20200182836
    Abstract: An inspection device has a particle detector adapted to detect particles in a liquid, a seat adapted to position a container housing the liquid in an area of operation of the particle detector and a vibration arrangement for vibrating the container. The vibration arrangement includes a frequency generator adapted to provide an electrical signal and a transducer adapted to transduce the electrical signal provided by the frequency generator into an acoustic wave. The seat is adapted to position the container adjacent to the transducer. for inspecting a liquid inside a container with respect to the existence of particles. The inspection device allows for an accurate and gentle inspection of the liquid filled in the container and for detecting particles in the liquid.
    Type: Application
    Filed: June 27, 2017
    Publication date: June 11, 2020
    Inventors: Tobias WERK, Anke DORN, imke Sonja LUDWIG, Hanns-Christian MAHLER, Denis LUTHRINGER, Carmen LEMA MARTINEZ, Jörg LÜMKEMANN
  • Publication number: 20200025664
    Abstract: The invention refers to an in vitro method and apparatus for analysing the behaviour of substances in simulated physiological environment. The method comprises the steps of providing a first fluid, a gel matrix and a second fluid, separating the first fluid and the gel matrix by at least one first semi-permeable membrane and separating the gel matrix and the second fluid by at least one second semi-permeable membrane. The method further comprises the steps of injecting a substance into the first fluid, letting the substance migrate from the first fluid through the at least one first semi-permeable membrane, through the gel matrix, through the at least one second semi-permeable membrane and into the second fluid, and determining clearance of the substance from the first fluid.
    Type: Application
    Filed: September 20, 2019
    Publication date: January 23, 2020
    Inventors: Hanns-Christian Mahler, Dhananjay Jagdish Jere, Sulabh Patel
  • Publication number: 20190367629
    Abstract: The present invention relates to a highly concentrated, stable pharmaceutical formulation of a pharmaceutically active anti-CD20 antibody, such as e.g. Rituximab, Ocrelizumab, or HuMab<CD20>, 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-CD20 antibody, an effective amount of at least one hyaluronidase enzyme as a combined formulation or for use in form of a co-formulation. The said 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: Application
    Filed: June 24, 2019
    Publication date: December 5, 2019
    Applicant: Genentech, Inc.
    Inventors: Michael Adler, Hanns-Christian Mahler, Oliver Boris Stauch
  • Patent number: 10458891
    Abstract: The invention refers to an in vitro method and apparatus for analyzing the behavior of substances in simulated physiological environment. The method comprises the steps of providing a first fluid, a gel matrix and a second fluid, separating the first fluid and the gel matrix by at least one first semi-permeable membrane and separating the gel matrix and the second fluid by at least one second semi-permeable membrane. The method further comprises the steps of injecting a substance into the first fluid, letting the substance migrate from the first fluid through the at least one first semi-permeable membrane, through the gel matrix, through the at least one second semi-permeable membrane and into the second fluid, and determining clearance of the substance from the first fluid.
    Type: Grant
    Filed: August 19, 2015
    Date of Patent: October 29, 2019
    Assignee: Hoffmann-La Roche Inc.
    Inventors: Hanns-Christian Mahler, Dhananjay Jagdish Jere, Sulabh Patel
  • Patent number: 10377831
    Abstract: The present invention relates to a highly concentrated, stable pharmaceutical formulation of a pharmaceutically active anti-CD20 antibody, such as e.g. Rituximab, Ocrelizumab, or HuMab<CD20>, 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-CD20 antibody, an effective amount of at least one hyaluronidase enzyme as a combined formulation or for use in form of a co-formulation. The said 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: Grant
    Filed: November 18, 2015
    Date of Patent: August 13, 2019
    Assignee: Genentech, Inc.
    Inventors: Michael Adler, Hanns-Christian Mahler, Oliver Boris Stauch
  • Patent number: 10280227
    Abstract: The present invention relates to a highly concentrated, stable pharmaceutical formulation of a pharmaceutically active anti-CD20 antibody, such as e.g. Rituximab, Ocrelizumab, or HuMab<CD20>, 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-CD20 antibody, an effective amount of at least one hyaluronidase enzyme as a combined formulation or for use in form of a co-formulation. The said 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: Grant
    Filed: April 24, 2014
    Date of Patent: May 7, 2019
    Assignee: Genentech, Inc.
    Inventors: Michael Adler, Hanns-Christian Mahler, Oliver Boris Stauch
  • Patent number: 10209211
    Abstract: A method for determining whether reconstitution of a solution in a container is completed comprises the steps of: selecting a predetermined amount of a solid substance and a predetermined amount of a liquid solvent from which the reconstituted solution is to be prepared, preparing a solution by solving the predetermined amount of the solid substance in the predetermined amount of the liquid solvent, measuring the impedance (Z) or the resistance (R) of the solution, determining whether the change of the measured impedance (Z) or the resistance (R) within a measuring time interval of a predetermined duration is below a defined threshold, and determining that reconstitution of the solution is completed when the change of the measured impedance (Z) is below the defined threshold.
    Type: Grant
    Filed: June 26, 2015
    Date of Patent: February 19, 2019
    Assignee: Hoffman-La Roche Inc.
    Inventors: Tobias Werk, Jörg Lümkemann, René Rietmann, Roger Steiner, Hanns-Christian Mahler
  • Publication number: 20180256818
    Abstract: A multi chamber syringe unit includes a longitudinal body with side wall, distal end side, proximal end side opposite to distal end side, an interior limited by side wall between distal end side and proximal end side and distal opening arranged in distal end side for providing a liquid out of the body. The syringe further includes a separating element arranged in the interior of the body such that distal chamber and proximal chamber are formed in the interior of the body, wherein the separating element seals the distal chamber from the proximal chamber. The syringe has a bypass arrangement provided in the side wall of distal chamber of the body. A first pharmaceutical liquid is arranged in distal chamber of the body and second pharmaceutical liquid in proximal chamber of the body. The multi chamber syringe unit allows for adequately administering plural pharmaceutical liquids by injection.
    Type: Application
    Filed: September 29, 2016
    Publication date: September 13, 2018
    Inventors: Jörg LÜMKEMANN, Hanns-Christian MAHLER, Toblas WERK