Patents Examined by James L Rogers
  • Patent number: 10457720
    Abstract: The present invention refers to a method for the separation of host cell proteins (HCPs), antibody fragments and low molecular weight substances from solutions containing antibodies.
    Type: Grant
    Filed: February 18, 2015
    Date of Patent: October 29, 2019
    Assignee: Merck Patent GmbH
    Inventors: Romas Skudas, Matthias Joehnck, Bianca Edelmann, Simon Braun, Mikhail Kozlov, Matthew T. Stone, Kevin Galipeau
  • Patent number: 10422807
    Abstract: The present invention provides a sensitive and specific indirect homogeneous mobility shift assay using size exclusion chromatography to measure biologics such as vedolizumab and ustekinumab in a patient sample. The assays of the present invention are particularly advantageous for detecting the presence or level of biologics that target complex or large antigens including cell surface proteins, transmembrane proteins, heavily glycosylated proteins, and multimeric proteins, as well as antigens that cannot be purified, impure antigens, and partially or substantially purified antigens. The present invention also provides isolated soluble ?4?7 integrin heterodimers and isolated soluble IL-12p40 monomers that are suitable for use in the indirect assays described herein.
    Type: Grant
    Filed: May 23, 2017
    Date of Patent: September 24, 2019
    Assignee: PRECISION IBD, INC.
    Inventors: Jared Salbato, Stefan Westin, Nicholas Chi-Kwan Ling, Anjali Jain, Sharat Singh
  • Patent number: 10414794
    Abstract: Provided herein is a novel method of purifying an IgG antibody from a preparation by use of an electropositive membrane having a defined porosity.
    Type: Grant
    Filed: February 17, 2015
    Date of Patent: September 17, 2019
    Inventor: Peter Stanley Gagnon
  • Patent number: 10414816
    Abstract: The present invention relates to a method for purifying an immunoglobulin, and more particularly, to a method for purifying an immunoglobulin, which comprises: dissolving immunoglobulin-containing plasma protein fraction I+II+III or fraction II+III; adding caprylate to the solution to cause precipitation; performing dialysis and concentration after removal of the precipitate; performing anion exchange resin and ceramic cation exchange resin purification processes to effectively remove a solvent and detergent added to inactivate viruses; and performing elution while maintaining salt concentration at a constant level to maintain the immunoglobulin polymer content at a low level.
    Type: Grant
    Filed: March 11, 2014
    Date of Patent: September 17, 2019
    Inventors: Dong-Hwarn Park, Ki-Hwan Son, Kang Yun Seo, Sung Min Choi, Gun Sul Lee, Ki-Yong Kim
  • Patent number: 10400042
    Abstract: A method for conversion of an N-terminal glutamine and/or glutamic acid residue of a protein to pyro-glutamic acid within a purification process.
    Type: Grant
    Filed: April 3, 2014
    Date of Patent: September 3, 2019
    Inventors: Marie Rose Van Schravendijk, Stephen Waugh, Barbara Thorne
  • Patent number: 10377793
    Abstract: Herein is reported a method for producing a polypeptide in monomeric form comprising the following step: recovering the polypeptide in monomeric form from an ion exchange chromatography material by applying a solution comprising a non-ionic polymer and an additive.
    Type: Grant
    Filed: June 16, 2016
    Date of Patent: August 13, 2019
    Assignee: Hoffmann-La Roche Inc.
    Inventor: Sebastian Neumann
  • Patent number: 10377794
    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: July 21, 2016
    Date of Patent: August 13, 2019
    Inventors: Roberto Falkenstein, Thorsten Lemm, Markus Strasser, Hidenari Yamada
  • Patent number: 10364268
    Abstract: Methods of enhancing efficiency of downstream chromatography steps for purification of proteins comprising: (a) passing a composition comprising a polypeptide of interest and various contaminants through an ion exchange membrane, wherein the polypeptide and the membrane have opposite charge, at operating conditions comprised of a buffer having a pH sufficiently distinct from the pi of the polypeptide to enhance the charge of the polypeptide and a low ionic strength effective to prevent the shielding of charges by buffer ions, which cause the membrane to bind the polypeptide and at least one contaminant, (b) overloading the ion exchange membrane such that at least one contaminant remains bound to the membrane while the polypeptide of interest is primarily in the effluent; (c) collecting the effluent from the ion exchange membrane comprising the polypeptide of interest; (d) subjecting the membrane effluent comprising the polypeptide of interest to a purification step of similar charge as the previous membrane,
    Type: Grant
    Filed: December 18, 2012
    Date of Patent: July 30, 2019
    Assignee: Genentech, Inc.
    Inventors: Jerome Joseph Bill, Jr., Arick Michael Brown, Christopher John Dowd, Brooke Ellen Thayer
  • Patent number: 10358462
    Abstract: The present invention relates to a method for the preparation of a solution of immunoglobulins based on an initial solution of immunoglobulins with a purity greater than or equal to 96% in the presence of a polyether or polymer of glycol, characterized in that it comprises the steps of: a) adding caprylic acid or salts of the same to the initial solution; b) adjusting the pH of the solution obtained in step a); c) incubating the solution obtained in step b) for the time and at a temperature necessary for the inactivation of enveloped viruses; d) performing a step of ultrafiltration/diafiltration on the solution obtained in step c).
    Type: Grant
    Filed: September 26, 2016
    Date of Patent: July 23, 2019
    Inventors: Pere Ristol Debart, Salvador Grancha Gamon, Juan Ignacio Jorquera Nieto, Maria Mercedes Faro Tomas, Nuria Jorba Grifols
  • Patent number: 10351592
    Abstract: The present invention relates to a method for separating antibody isoforms using cation exchange chromatography and, more specifically, to a method for separating and purifying several isoforms, which are generated during an antibody production procedure, using a washing buffer for cation exchange chromatography.
    Type: Grant
    Filed: October 24, 2014
    Date of Patent: July 16, 2019
    Assignee: CELLTRION, INC.
    Inventors: Dong Woo Lee, Mi Na Song, Byoung Oh Kwon, Ki Sung Kwon, Dong Rim Yeom, Yeon Jung Kim
  • Patent number: 10329323
    Abstract: Disclosed here includes a method for purifying a biologic composition, comprising diafiltering the biologic composition into a composition comprising phosphate buffered saline (PBS) to obtain a purified composition. The method disclosed here can be particularly useful for removing one or more impurities from the biologic composition, such as bis(2-hydroxyethyl)amino-tris(hydroxymethyl)methane (Bis-tris).
    Type: Grant
    Filed: July 25, 2015
    Date of Patent: June 25, 2019
    Assignees: The United States of America, as represented by the Secretary, Department of Health & Human Services, United Therapeutics Corporation
    Inventors: Samir H. Shaban, Mary P. Koleck, David A. Meh, Gerald M. Farquharson, Timothy O. Atolagbe, George Mitra
  • Patent number: 10316059
    Abstract: The present invention is directed to methods comprising the use of hydroxyapatite chromatography to separate a bispecific antibody from a solution that also comprises one or more byproducts specific to bispecific antibody production. Byproducts specific to the production of bispecific antibodies (bispecific antibody specific byproducts, “BASB”) include fragments of the bispecific antibody and heavier molecular weight variants of the antibody, wherein the fragment and/or variant comprises an Fc domain but does not exhibit affinity for the two different epitopes and/or antigens as exhibited by the desired bispecific antibody. Thus, the methods of the present invention comprise the separation of a bispecific antibody from one or more of its BASB. The hydroxyapatite chromatography methods of the invention may be used alone or may be further combined with standard purification processes and unit operations as is known in the art to achieve any level of purity of bispecific antibody necessary, e.g.
    Type: Grant
    Filed: February 19, 2016
    Date of Patent: June 11, 2019
    Assignee: Hoffmann-La Roche Inc.
    Inventors: Sabine Bertl, Harald Duerr, Andreas Schaubmar
  • Patent number: 10308690
    Abstract: The invention discloses a polypeptide with improved alkaline stability, which polypeptide comprises a mutant of a B or C domain of Staphylococcus Protein A (SpA), as specified by SEQ ID NO 1 or SEQ ID NO 2, or of Protein Z, as specified by SEQ ID NO 3, comprising at least the mutation wherein the glutamine residue at position 9 has been mutated to a tryptophan, leucine, glutamic acid, valine or lysine. The invention also discloses multimers of the polypeptide, as well as separation matrices comprising the multimers or polypeptides.
    Type: Grant
    Filed: December 7, 2015
    Date of Patent: June 4, 2019
    Inventors: Gustav Rodrigo, Mats Ander, Göran Baurén, Tomas Björkman
  • Patent number: 10294306
    Abstract: Affinity ligands useful for mild elution affinity chromatography, including affinity ligands specific for immunoglobulins M, A, and E, are disclosed as are method of identifying and using such affinity ligands.
    Type: Grant
    Filed: May 27, 2016
    Date of Patent: May 21, 2019
    Assignee: Bio-Rad Laboratories, Inc.
    Inventors: Achim Knappik, Stefan Paschen
  • Patent number: 10287314
    Abstract: The present invention provides novel and improved protein purification processes which incorporate certain types of carbonaceous materials and result in effective and selective removal of certain undesirable impurities without adversely effecting the yield of the desired protein product.
    Type: Grant
    Filed: June 23, 2015
    Date of Patent: May 14, 2019
    Assignee: EMD Millipore Corporation
    Inventors: Nanying Bian, Christopher Gillespie, Matthew T. Stone, Mikhail Kozlov, Jie Chen, Martin Siwak
  • Patent number: 10287315
    Abstract: The present invention relates to a method for purifying an immunoglobulin, and more particularly, to a method for purifying an immunoglobulin, which comprises: dialyzing and concentrating an immunoglobulin-containing plasma protein fraction II paste; removing thrombotic substances from the dialyzed and concentrated fraction by a purification process using ceramic cation exchange resin; and performing elution while maintaining salt concentration at a constant level to maintain the polymer content of the immunoglobulin at a low level. When the immunoglobulin purification method according to the present invention is used, the efficiency with which impurities and thrombotic substances are removed can be increased and the polymer content of the immunoglobulin can be maintained, and thus a stable immunoglobulin with improved quality can be produced.
    Type: Grant
    Filed: March 11, 2014
    Date of Patent: May 14, 2019
    Inventors: Ki-Hwan Son, Yong Kang, Dong-Hwarn Park, Sung Min Choi, Kang Yun Seo, Ki-Yong Kim
  • Patent number: 10266562
    Abstract: The present invention relates to a purification and concentration method for proteins and antibodies. Particularly the present invention relates to a continuous surfactant based phase separation method for recovering hydrophobin fusion proteins, and for recovering target molecules, such as antibodies, directly from a liquid by using phase separation and hydrophobin-Protein A fusion technologies.
    Type: Grant
    Filed: July 1, 2014
    Date of Patent: April 23, 2019
    Assignee: Teknologian tutkimuskeskus VTT Oy
    Inventors: Jussi Joensuu, Markus Linder, Eero Mustalahti, Katri Kurppa
  • Patent number: 10259842
    Abstract: Described herein is a method for separating a recombinantly produced polypeptide from host cell protein. The method includes a step of loading a clarified cell culture supernatant that includes the recombinantly produced polypeptide and the HCP onto a Protein A chromatography column and washing the Protein A chromatography column with a wash buffer comprising a fatty acid having a chain length of at least about 6 carbon atoms, or a fatty acid salt thereof to remove HCP and then recovering the recombinantly produced polypeptide.
    Type: Grant
    Filed: May 13, 2014
    Date of Patent: April 16, 2019
    Assignees: MedImmune, LLC, Medimmune Limited
    Inventors: David Edwin Gruber, Richard Edward Turner, Jared Samuel Bee, Christopher Douglas Afdahl, Liu Tie
  • Patent number: 10246484
    Abstract: A method is provided for purifying a recombinant protein from a mixture comprising the recombinant protein and related proteins, comprising the steps of: A. using a first equilibrating buffer in a first conductivity and pH to make the recombinant protein bind to an ion exchange medium; B. using a second equilibration buffer in a second conductivity and pH to continually equilibrate the ion exchange medium bound to the protein; C. using a washing liquid in a third conductivity and a gradually increasing pH to wash the ion-exchange medium, and eluting the first category-related proteins; D. using a first eluent in a fourth conductivity and pH to elute the ion exchange medium, and eluting the target recombinant protein; and E. using a second eluent in a fifth conductivity and pH to continually elute the ion exchange medium, and eluting the second category-related proteins.
    Type: Grant
    Filed: November 3, 2014
    Date of Patent: April 2, 2019
    Inventors: Hui Hu, Yunbin Zhu, Meiling Zang
  • Patent number: 10233211
    Abstract: The present invention relates to a selectively soluble polymer capable of binding to a desired molecules in an unclarified mixture containing various biological materials and the methods of using such a polymer to purify a molecule from such a mixture. The polymer is soluble in the mixture under a certain set of process conditions such as pH or temperature and/or salt concentration and is rendered insoluble and precipitates out of solution upon a change in the process conditions. The polymer is capable of binding to the desired molecule (protein, polypeptide, etc) and remains capable of binding to that molecule even after the polymer is precipitated out of solution. The precipitate can then be filtered out from the remainder of the stream and the desired biomolecule is recovered such as by elution and further processed.
    Type: Grant
    Filed: July 31, 2013
    Date of Patent: March 19, 2019
    Assignee: EMD Millipore Corporation
    Inventors: Wilson Moya, Jad Jaber