Patents by Inventor Roberto Falkenstein

Roberto Falkenstein 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).

  • Patent number: 10273277
    Abstract: Herein is reported a method for the purification of a protein comprising erythropoietin and a single poly (ethylene glycol) residue from reaction by-products or not reacted starting material by a cation exchange chromatography method. It has been found that by employing a cation exchange SP Sephacrylâ„¢ S 500 HR chromatography material conditioned to a conductivity of 21 mS/cm and a linear gradient elution a fusion protein of erythropoietin and a single poly (ethylene glycol) residue can be obtained in a single step with high purity and yield.
    Type: Grant
    Filed: February 19, 2016
    Date of Patent: April 30, 2019
    Assignee: Hoffmann-La Roche Inc.
    Inventors: Roberto Falkenstein, Wolfgang Koehnlein, Wolfgang Kuhne, Hartmut Schurig
  • Patent number: 10087237
    Abstract: Herein is reported a method for producing an antibody preparation comprising the steps of a) applying a buffered solution comprising different isoforms of an antibody to a cation exchange chromatography material, b) applying a first solution with a first conductivity to the cation exchange chromatography material, whereby the antibody isoforms remain bound to the cation exchange chromatography material, and c) applying a second solution with a second conductivity to the cation exchange chromatography material and thereby obtaining the antibody preparation, whereby the conductivity of the second solution exceeds the conductivity of the first solution by not more than 10%.
    Type: Grant
    Filed: November 6, 2015
    Date of Patent: October 2, 2018
    Assignee: F. HOFFMANN-LA ROCHE AG
    Inventors: Roberto Falkenstein, Klaus Schwendner, Bernhard Spensberger
  • Patent number: 10052567
    Abstract: The current invention is directed to a chromatography column separator which separates the chromatography column in an upper chromatography column chamber and a lower chromatography column chamber, and which has a variable position within the chromatography column, and which is embedded by the chromatography material. The separator allows the replacement of the chromatography material in the upper chromatography column chamber without the need to replace the chromatography column material in the lower chromatography column chamber and it allows also the combination of two different chromatography materials with different chromatographical functional groups in one chromatography column.
    Type: Grant
    Filed: January 26, 2016
    Date of Patent: August 21, 2018
    Assignee: HOFFMANN-LA ROCHE INC.
    Inventors: Andreas Blaschyk, Roberto Falkenstein
  • Publication number: 20180186865
    Abstract: Herein is reported a method for producing a human IgG4 or IgG1 isotype antibody comprising the following steps a) cultivating a cell comprising a nucleic acid encoding a human IgG4 or IgG1 isotype antibody, b) recovering the human IgG4 or IgG1 isotype antibody from the cell or the cultivation medium, c) contacting the human IgG4 or IgG1 isotype antibody with a protein A chromatography material, d) washing the protein A chromatography material with an aqueous solution comprising Histidine and Tris, e) recovering the human IgG4 or IgG1 isotype antibody from the protein A chromatography material and thereby producing the human IgG4 or IgG1 isotype antibody.
    Type: Application
    Filed: February 20, 2018
    Publication date: July 5, 2018
    Applicant: Hoffmann-La Roche Inc.
    Inventors: Roberto FALKENSTEIN, Wolfgang KOEHNLEIN, Klaus SCHWENDNER, Bernhard SPENSBERGER
  • Publication number: 20180186866
    Abstract: Herein is reported a method for producing a bispecific antibody comprising a first antigen-binding site that specifically binds to a first antigen and a second antigen-binding site that specifically binds to a second antigen comprising the following steps a) cultivating a cell comprising a nucleic acid encoding the bispecific antibody, b) recovering the bispecific antibody from the cell or the cultivation medium, c) contacting the bispecific antibody with an affinity chromatography material, d) washing the affinity chromatography material with a low conductivity aqueous solution, wherein the low conductivity aqueous solution has a conductivity value of about 0.5 mS/cm or less, e) recovering the bispecific antibody from the affinity chromatography material, f) performing a further chromatography step and thereby producing the bispecific antibody.
    Type: Application
    Filed: February 20, 2018
    Publication date: July 5, 2018
    Applicant: Hoffmann-La Roche Inc.
    Inventors: Roberto FALKENSTEIN, Eva ROSENBERG, Agathe BIALAS, Steffen WILLMANN
  • Publication number: 20180186832
    Abstract: The current invention reports a method for purifying an antibody by reducing the content of a host cell protein. The method employs a wash step with a low conductivity aqueous solution in an affinity chromatography.
    Type: Application
    Filed: February 20, 2018
    Publication date: July 5, 2018
    Applicants: Genentech, Inc., Hoffmann-La Roche Inc
    Inventors: Paul MCDONALD, Richard ST. JOHN, Marc WONG, Roberto FALKENSTEIN, Wolfgang KOEHNLEIN, Klaus SCHWENDNER, Bernhard SPENSBERGER, Michael WIEDMANN, Frank ZETTL, Annika KLEINJANS, Carina KOPP, Benjamin TRAN, Ryan ERICKSON
  • Publication number: 20180009878
    Abstract: Herein is reported a method for the final filtration of concentrated polypeptide solutions comprising the combination of two immediately consecutive filtration steps with a first filter of 3.0 ?m and 0.8 ?m pore size and a second filter of 0.45 ?m and 0.22 ?m pore size.
    Type: Application
    Filed: February 27, 2017
    Publication date: January 11, 2018
    Applicant: Hoffmann-La Roche Inc.
    Inventors: Roberto Falkenstein, Klaus Schwendner
  • Publication number: 20170183394
    Abstract: A method for the purification of immunoglobulins by ion exchange chromatography is described. The chromatographic method uses a weak ion exchange resin and a single step elution process for the purification of an immunoglobulin. Additionally a method for the determination of the salt concentration for the single step elution of an immunoglobulin from an ion exchange resin is described.
    Type: Application
    Filed: March 14, 2017
    Publication date: June 29, 2017
    Inventors: Roberto Falkenstein, Burkard Kolb, Maria Sebald
  • Publication number: 20170137497
    Abstract: The current invention reports a method for purifying an immunoglobulin, wherein the method comprises applying an aqueous, buffered solution comprising an immunoglobulin in monomeric and in aggregated form to a cation exchange material under conditions whereby the immunoglobulin in monomeric form does not bind to the cation exchange material, and recovering the immunoglobulin in monomeric form from the solution after the contact with the cation exchange material.
    Type: Application
    Filed: October 19, 2016
    Publication date: May 18, 2017
    Inventors: Roberto Falkenstein, Claudia Giessel
  • Patent number: 9631007
    Abstract: A method for the purification of immunoglobulins by ion exchange chromatography is described. The chromatographic method uses a weak ion exchange resin and a single step elution process for the purification of an immunoglobulin. Additionally a method for the determination of the salt concentration for the single step elution of an immunoglobulin from an ion exchange resin is described.
    Type: Grant
    Filed: May 6, 2014
    Date of Patent: April 25, 2017
    Assignee: HOFFMANN-LA-ROCHE INC.
    Inventors: Roberto Falkenstein, Burkard Kolb, Maria Sebald
  • Publication number: 20170066814
    Abstract: Herein is reported a method for producing an antibody preparation comprising the steps of a) applying a buffered solution comprising different isoforms of an antibody to a cation exchange chromatography material, b) applying a first solution with a first conductivity to the cation exchange chromatography material, whereby the antibody isoforms remain bound to the cation exchange chromatography material, and c) applying a second solution with a second conductivity to the cation exchange chromatography material and thereby obtaining the antibody preparation, whereby the conductivity of the second solution exceeds the conductivity of the first solution by not more than 10%.
    Type: Application
    Filed: November 6, 2015
    Publication date: March 9, 2017
    Applicant: Hoffmann-La Roche Inc.
    Inventors: Roberto Falkenstein, Klaus Schwendner, Bernhard Spensberger
  • Publication number: 20170015702
    Abstract: Herein is reported a method for the purification of an antibody directly captured from clarified cell culture supernatants using Streamline CST and/or Capto MMC, wherein especially product related (aggregates and fragments) and process related impurities (host cell protein, media components) could efficiently be removed, resulting in a preparation with a purity comparable to classical protein A affinity chromatography.
    Type: Application
    Filed: July 21, 2016
    Publication date: January 19, 2017
    Inventors: Roberto Falkenstein, Thorsten Lemm, Markus Strasser, Hidenari Yamada
  • Publication number: 20170008941
    Abstract: Herein is reported a method for the purification of a protein comprising erythropoietin and a single poly (ethylene glycol) residue from reaction by-products or not reacted starting material by a cation exchange chromatography method. It has been found that by employing a cation exchange SP Sephacrylâ„¢ S 500 HR chromatography material conditioned to a conductivity of 21 mS/cm and a linear gradient elution a fusion protein of erythropoietin and a single poly (ethylene glycol) residue can be obtained in a single step with high purity and yield.
    Type: Application
    Filed: February 19, 2016
    Publication date: January 12, 2017
    Applicant: Hoffmann-La Roche Inc.
    Inventors: Roberto Falkenstein, Wolfgang Koehnlein, Wolfgang Kuhne, Hartmut Schurig
  • Patent number: 9493548
    Abstract: The current invention reports a method for purifying an immunoglobulin, wherein the method comprises applying an aqueous, buffered solution comprising an immunoglobulin in monomeric and in aggregated form to a cation exchange material under conditions whereby the immunoglobulin in monomeric form does not bind to the cation exchange material, and recovering the immunoglobulin in monomeric form from the solution after the contact with the cation exchange material.
    Type: Grant
    Filed: May 28, 2008
    Date of Patent: November 15, 2016
    Assignee: Hoffmann-La Roche Inc.
    Inventors: Roberto Falkenstein, Claudia Giessel
  • Patent number: 9481706
    Abstract: The current invention reports a method for the purification of a not-glycosylated, heterologous polypeptide, which has been recombinantly produced in a prokaryotic cell, wherein the method comprises three chromatography steps of which the first chromatography step selected from i) hydrophobic charge induction chromatography, or ii) hydrophobic interaction chromatography, or iii) affinity chromatography, or iv) ion exchange chromatography, the second chromatography step is selected from i) anion exchange chromatography, or ii) cation exchange chromatography, or iii) hydroxylapatite chromatography, or iv) hydrophobic interaction chromatography, and the a third chromatography step is selected from i) hydrophobic charge induction chromatography, or ii) anion exchange chromatography, or iii) cation exchange chromatography, or iv) hydrophobic interaction chromatography, whereby the first chromatography step is an affinity chromatography in case of polypeptides capable of interacting with metal ligands, the second c
    Type: Grant
    Filed: April 7, 2014
    Date of Patent: November 1, 2016
    Assignee: Hoffmann-La Roche Inc.
    Inventors: Roberto Falkenstein, Birgit Weydanz, Nicole Fuehrler, Claudia Giessel, Sybille Gabel, Adelbert Grossmann, Friederike Hesse, Marc Pompiati, Andreas Schaubmar, Brigitte Kraemer
  • Patent number: 9422329
    Abstract: Herein is reported a method for the purification of an antibody directly captured from clarified cell culture supernatants using Streamline CST and/or Capto MMC, wherein especially product related (aggregates and fragments) and process related impurities (host cell protein, media components) could efficiently be removed, resulting in a preparation with a purity comparable to classical protein A affinity chromatography.
    Type: Grant
    Filed: November 2, 2011
    Date of Patent: August 23, 2016
    Assignee: Hoffmann-La Roche Inc.
    Inventors: Roberto Falkenstein, Thorsten Lemm, Markus Strasser, Hidenari Yamada
  • Publication number: 20160237140
    Abstract: Herein is reported a method for purifying a polypeptide comprising the steps of i) applying a solution comprising the polypeptide to an ion exchange chromatography material, and ii) recovering the polypeptide with a solution comprising a denaturant and thereby purifying the polypeptide, whereby the ion exchange chromatography material comprises a matrix of cross-linked poly (styrene-divinylbenzene) to which ionic ligands have been attached, and wherein the solution comprising the polypeptide applied to the ion exchange chromatography material is free of the denaturant and the polypeptide adsorbed to the ion exchange chromatography material is recovered with a solution comprising a denaturant at a constant conductivity.
    Type: Application
    Filed: October 22, 2015
    Publication date: August 18, 2016
    Applicant: Hoffmann-La Roche Inc.
    Inventors: Roberto Falkenstein, Maria Laura Magri, Michaela Mehr, Klaus Schwendner, Bernhard Spensberger
  • Publication number: 20160214031
    Abstract: The current invention is directed to a chromatography column separator which separates the chromatography column in an upper chromatography column chamber and a lower chromatography column chamber, and which has a variable position within the chromatography column, and which is embedded by the chromatography material. The separator allows the replacement of the chromatography material in the upper chromatography column chamber without the need to replace the chromatography column material in the lower chromatography column chamber and it allows also the combination of two different chromatography materials with different chromatographical functional groups in one chromatography column.
    Type: Application
    Filed: January 26, 2016
    Publication date: July 28, 2016
    Inventors: Andreas BLASCHYK, Roberto FALKENSTEIN
  • Patent number: 9289699
    Abstract: The current invention is directed to a chromatography column separator which separates the chromatography column in an upper chromatography column chamber and a lower chromatography column chamber, and which has a variable position within the chromatography column, and which is embedded by the chromatography material. The separator allows the replacement of the chromatography material in the upper chromatography column chamber without the need to replace the chromatography column material in the lower chromatography column chamber and it allows also the combination of two different chromatography materials with different chromatographical functional groups in one chromatography column.
    Type: Grant
    Filed: July 28, 2010
    Date of Patent: March 22, 2016
    Assignee: Hoffmann-La Roche Inc.
    Inventors: Andreas Blaschyk, Roberto Falkenstein
  • Patent number: 9206227
    Abstract: Herein is reported a method for the purification of an antibody directly captured from clarified cell culture supernatants using Streamline CST and/or Capto MMC, wherein especially product related (aggregates and fragments) and process related impurities (host cell protein, media components) could efficiently be removed, resulting in a preparation with a purity comparable to classical protein A affinity chromatography.
    Type: Grant
    Filed: November 2, 2011
    Date of Patent: December 8, 2015
    Assignee: Hoffmann-La Roche Inc.
    Inventors: Roberto Falkenstein, Thorsten Lemm, Markus Strasser, Hidenari Yamada