Patents by Inventor Akhilesh Bhambhani

Akhilesh Bhambhani 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: 20220265558
    Abstract: Disclosed herein are methods for preparing and/or dispensing lyospheres of pharmaceutical compositions of biologics (e.g., vaccines, therapeutic proteins such as monoclonal antibodies) or small molecules (e.g., chemical compounds). Also described are assemblies and systems for preparing and/or dispensing the lyospheres.
    Type: Application
    Filed: July 23, 2020
    Publication date: August 25, 2022
    Applicant: Merck Sharp & Dohme Corp.
    Inventors: Akhilesh Bhambhani, Morrisa Jones, Derrick M. Smith, David S. Thiriot, Joseph M. Rock
  • Publication number: 20220105169
    Abstract: The present invention provides polysaccharide-protein conjugate vaccine formulations comprising a buffer, surfactant, sugar, alkali or alkaline salt, aluminum adjuvant, optionally a bulking agent, and optionally a polymer.
    Type: Application
    Filed: December 17, 2021
    Publication date: April 7, 2022
    Applicant: Merck Sharp & Dohme Corp.
    Inventors: Ramesh V. Chintala, Akhilesh Bhambhani, Christopher David Mensch, Denise K. Nawrocki, Jeffrey Thomas Blue
  • Publication number: 20210252126
    Abstract: A method is described for reconstituting lyophilized mutant diphtheria toxin in dimethyl sulfoxide for use in producing pneumococcal capsular polysaccharide mutant diphtheria toxin conjugates.
    Type: Application
    Filed: April 25, 2019
    Publication date: August 19, 2021
    Applicant: Merck Sharp & Dohme Corp.
    Inventors: Patrick Leonard Ahl, Akhilesh Bhambhani, Christopher Jon Farrell, Patrick McHugh, Morrisa C. Jones, Daniel D. Roth, Jessica R. Sinacola, Justin Stanbro, Matthew P. Watson, Emily Wen, Michael A. Winters
  • Publication number: 20210252125
    Abstract: A method is described for producing a pneumococcal capsular polysaccharide protein conjugate in which one or more activated pneumococcal polysaccharides of particular pneumococcal serotypes and carrier protein are separately lyophilized, the separately lyophilized polysaccharides and carrier protein are separately reconstituted in an organic solvent, and the reconstituted polysaccharide and carrier protein are then combined together by Tee-mixing and conjugated together to produce polysaccharide carrier protein conjugates. A plurality of conjugates, each comprising polysaccharides of a particular serotype, may be used to produce multivalent pneumococcal immunogenic compositions having a combination of conjugates for use in vaccines.
    Type: Application
    Filed: April 25, 2019
    Publication date: August 19, 2021
    Applicant: Merck Sharp & Dohme Corp.
    Inventors: Patrick Leonard Ahl, Akhilesh Bhambhani, Christopher Jon Farrell, Patrick McHugh, Morrisa C. Jones, Daniel D. Roth, Jessica R. Sinacola, Justin Stanbro, Matthew P. Watson, Emily Wen, Michael A. Winters
  • Publication number: 20210236646
    Abstract: A method is described for producing a pneumococcal capsular polysaccharide protein conjugate in which one or more activated pneumococcal polysaccharides of particular pneumococcal serotypes and carrier protein are separately lyophilized in the form of lyospheres of carrier protein and lyospheres of the one or more polysaccharides. A predetermined amount of carrier protein lyospheres and activated polysaccharide lyospheres are mixed together and the mixture reconstituted in an organic solvent to produce polysaccharide carrier protein conjugates. A plurality of conjugates, each comprising polysaccharides of a particular serotype, may be used to produce multivalent pneumococcal immunogenic compositions having a combination of conjugates for use in vaccines.
    Type: Application
    Filed: April 25, 2019
    Publication date: August 5, 2021
    Applicant: Merck Sharp & Dohme Corp.
    Inventors: Patrick Leonard AHL, Akhilesh BHAMBHANI, Christopher Jon FARRELL, Patrick McHUGH, Morrisa C. JONES, Daniel D. ROTH, Jessica R. SINACOLA, Justin STANBRO, Matthew P. WATSON, Emily WEN, Michael A. WINTERS
  • Publication number: 20210223262
    Abstract: The present invention provides lyophilized pellets of low concentrations of antibodies in the form of lyospheres. These lyospheres provide pre-measured antibody concentrations suitable for diagnostic and quality control assays.
    Type: Application
    Filed: June 3, 2019
    Publication date: July 22, 2021
    Applicant: Merck Sharp & Dohme Corp.
    Inventors: Akhilesh Bhambhani, Thorsten Verch, Morrisa C. Jones, Mary Retzlaff, Jessica R. Sinacola, Silikhone L. Bouaraphan
  • Publication number: 20210048247
    Abstract: Methods for preparing dried pellets of biological materials are described. The pellets can have a substantially spherical shape and are prepared by freezing droplets of a liquid composition of a desired biological material on a solid surface followed by microwave vacuum drying the frozen droplets. These methods are useful for preparing dried pellets having a high concentration of a desired biological material, in particular a therapeutic protein or vaccine, and which have a faster reconstitution time than lyophilized powder cakes prepared in vials.
    Type: Application
    Filed: October 27, 2020
    Publication date: February 18, 2021
    Applicant: Merck Sharp & Dohme Corp.
    Inventors: Akhilesh Bhambhani, Robert K. Evans, Jessica Sinacola, Rebecca Lizzano
  • Publication number: 20200390877
    Abstract: The present invention relates to formulations of dengue virus vaccine comprising at least one live attenuated dengue virus or live attenuated chimeric flavivirus, a buffer, a sugar, a cellulose derivative, a glycol or sugar alcohol, optionally an alkali or alkaline salt and an amino acid; and formulations of dengue virus vaccine comprising at least one live attenuated dengue virus or live attenuated chimeric flavivirus, a buffer, a sugar of at least 150 mg/ml, a carrier, and optionally an alkali or alkaline salt and an amino acid.
    Type: Application
    Filed: December 3, 2018
    Publication date: December 17, 2020
    Applicant: Merck Sharp & Dohme Corp.
    Inventors: Michael S. Ryan, Sherrie-Ann P. Martin, Morrisa Jones, Justin Stanbro, Akhilesh Bhambhani, Jeffrey Thomas Blue, Heidi Joanne Pixley, Erin J. Green-Trexler, Lynne Ann Isopi
  • Publication number: 20200360500
    Abstract: The present invention provides polysaccharide-protein conjugate vaccine formulations comprising a buffer, surfactant, sugar, alkali or alkaline salt, aluminum adjuvant, optionally a bulking agent, and optionally a polymer.
    Type: Application
    Filed: August 13, 2018
    Publication date: November 19, 2020
    Applicant: Merck Sharp & Dohme Corp.
    Inventors: Ramesh V. Chintala, Akhilesh Bhambhani, Christopher David Mensch, Denise K. Nawrocki, Jeffrey Thomas Blue
  • Publication number: 20200325020
    Abstract: Vaccine formulations are described comprising physically separated, lyophilized antigens and adjuvant components, which may be in lyoparticle form, as well as methods of using and making such formulations. Reconstituted formulations are also described.
    Type: Application
    Filed: October 22, 2018
    Publication date: October 15, 2020
    Applicant: Merck Sharp & Dohme Corp.
    Inventors: Akhilesh Bhambhani, Muneeswara Babu Medi, Maya Salnikova, William James Smith, David S. Thiriot
  • Patent number: 10772947
    Abstract: The invention provides human papillomavirus (HPV) antigen formulations which show increased antigen stability. More specifically, the invention provides stable HPV formulations comprising HPV virus-like particles (VLPs) bound to an aluminum salt adjuvant and further comprise a combination of sucrose and mannitol. The vaccine formulations of the invention are stable following freeze-thaw and freeze-drying. Also provided are lyophilized and frozen HPV vaccine formulations comprising HPV VLPs of at least one HPV type adsorbed onto an aluminum salt adjuvant, sucrose, and mannitol. Methods of making the stable vaccine formulations of the invention are also provided.
    Type: Grant
    Filed: December 14, 2016
    Date of Patent: September 15, 2020
    Assignee: Merck Sharp & Dohme Corp.
    Inventors: Ramesh V. Chintala, Akhilesh Bhambhani
  • Publication number: 20200181678
    Abstract: The present invention relates to a cell-based reporter assay for determining viral potency comprising A) transfecting cells maintained in media with a promoter-reporter construct and generating reporter enzyme within the cells; B) infecting cells with a live virus or live virus vaccine wherein reporter enzyme is released into media; and C) measuring reporter enzyme intensity in media.
    Type: Application
    Filed: December 11, 2017
    Publication date: June 11, 2020
    Applicant: Merck Sharp & Dohme Corp.
    Inventors: BRIAN K. MEYER, AKHILESH BHAMBHANI, JEFFREY T. BLUE
  • Patent number: 10617650
    Abstract: The present invention provides a process for preparing enterically-coated lyospheres comprising a therapeutic agent comprising: a.) providing lyospheres comprising the therapeutic agent; b.) coating said lyospheres with an enteric polymer coating composition; and c.) isolating said enterically-coated lyospheres. In other embodiments, the invention provides dosage forms comprising a lyosphere comprising an effective amount of a therapeutic agent and an enteric polymer coating. In some embodiments, the therapeutic agent in the process or dosage form is a polypeptide, a protein, a peptide, a lipopeptide, a glycoprotein, a fusion protein, a protein conjugate, a cytokine, an enzyme, an antibody, an oligonucleotide, a vaccine vector, small molecule, a live virus, an inactivated virus, a virus-like particle, a viral protein subunit, an adjuvant, microbiome, a prebiotic, a probiotic, or an ectobiotic.
    Type: Grant
    Filed: October 11, 2016
    Date of Patent: April 14, 2020
    Assignee: Merck Sharp & Dohme Corp.
    Inventors: Akhilesh Bhambhani, Robert K. Evans, Pranav Gupta, Ronald L. Smith, Donna M. Williams
  • Publication number: 20190383556
    Abstract: Methods for preparing dried pellets of biological materials are described. The pellets can have a substantially spherical shape and are prepared by freezing droplets of a liquid composition of a desired biological material on a solid surface followed by microwave vacuum drying the frozen droplets. These methods are useful for preparing dried pellets having a high concentration of a desired biological material, in particular a therapeutic protein or vaccine, and which have a faster reconstitution time than lyophilized powder cakes prepared in vials.
    Type: Application
    Filed: August 30, 2019
    Publication date: December 19, 2019
    Applicant: Merck Sharp & Dohme Corp.
    Inventors: Akhilesh Bhambhani, Robert K. Evans, Jessica Sinacola, Rebecca Lizzano
  • Patent number: 10429129
    Abstract: Methods for preparing dried pellets of biological materials are described. The pellets can have a substantially spherical shape and are prepared by freezing droplets of a liquid composition of a desired biological material on a solid surface followed by microwave vacuum drying the frozen droplets. These methods are useful for preparing dried pellets having a high concentration of a desired biological material, in particular a therapeutic protein or vaccine, and which have a faster reconstitution time than lyophilized powder cakes prepared in vials.
    Type: Grant
    Filed: October 13, 2014
    Date of Patent: October 1, 2019
    Assignee: Merck Sharp & Dohme Corp.
    Inventors: Akhilesh Bhambhani, Robert K. Evans, Jessica Sinacola, Rebecca Lizzano
  • Patent number: 10369213
    Abstract: Methods for improving the drying yield and stability of RSV vaccines comprising a highly thermolabile enveloped live virus and/or one or more RSV protein subunits, are described. Methods for rapid drying of RSV formulations containing between 17.5% and 60% w/w of a non-polymeric sugar and using either conduction or radiation dominant drying mechanisms, are disclosed. The disclosed methods provide for; 1) a dried RSV formulation with improved stability profile; 2) faster drying; and 3) integration of dried RSV into a primary device (such as dual chamber cartridges, foil-pouch devices etc.), pre- as well as post-drying.
    Type: Grant
    Filed: October 13, 2014
    Date of Patent: August 6, 2019
    Assignee: Merck Sharp & Dohme Corp.
    Inventors: Akhilesh Bhambhani, Robert K. Evans, Lynne A. Isopi
  • Patent number: 10183968
    Abstract: Methods for preparing lyophilized pellets of biological materials are described. The pellets have a substantially spherical shape and are prepared by freezing droplets of a liquid composition of a desired biological material on a flat, solid surface, in particular, a surface that does not have any cavities, followed by lyophilizing the frozen droplets. These methods are useful for preparing lyophilized pellets having a high concentration of a desired biological material, in particular a therapeutic protein or vaccine, and which have a faster reconstitution time than lyophilized powder cakes prepared in vials.
    Type: Grant
    Filed: October 26, 2012
    Date of Patent: January 22, 2019
    Assignee: Merck Sharp & Dohme Corp.
    Inventors: Colleen Barr, Akhilesh Bhambhani, Robert Evans, Lynne Isopi, David Krah, Jennifer Kriss, Jessica Sinacola
  • Publication number: 20180311172
    Abstract: The present invention provides a process for preparing enterically-coated lyospheres comprising a therapeutic agent comprising: a.) providing lyospheres comprising the therapeutic agent; b.) coating said lyospheres with an enteric polymer coating composition; and c.) isolating said enterically-coated lyospheres. In other embodiments, the invention provides dosage forms comprising a lyosphere comprising an effective amount of a therapeutic agent and an enteric polymer coating. In some embodiments, the therapeutic agent in the process or dosage form is a polypeptide, a protein, a peptide, a lipopeptide, a glycoprotein, a fusion protein, a protein conjugate, a cytokine, an enzyme, an antibody, an oligonucleotide, a vaccine vector, small molecule, a live virus, an inactivated virus, a virus-like particle, a viral protein subunit, an adjuvant, microbiome, a prebiotic, a probiotic, or an ectobiotic.
    Type: Application
    Filed: October 11, 2016
    Publication date: November 1, 2018
    Applicant: Merck Sharp & Dohme Corp.
    Inventors: Akhilesh Bhambhani, Robert K. Evans, Pranav Gupta, Ronald L. Smith, Donna M. Williams
  • Patent number: 9782470
    Abstract: This present invention relates to compositions and methods for stabilizing a dried vaccine formulations. In particular, the invention provides a method for producing a vaccine composition comprising the steps of providing an aqueous composition comprising a buffer, the vaccine components and between 17.5% w/w and 60% w/w of a non-polymeric sugar, freezing the composition, and applying microwave radiation under a pressure lower than atmospheric pressure in order to sublimate the composition and obtain a dried vaccine formulation. The invention also provides a product obtainable by this method.
    Type: Grant
    Filed: October 13, 2014
    Date of Patent: October 10, 2017
    Assignee: Merck Sharp & Dohme Corp.
    Inventors: Akhilesh Bhambhani, Robert K. Evans, Jessica Sinacola, Morrisa Jones
  • Publication number: 20170157238
    Abstract: The invention provides human papillomavirus (HPV) antigen formulations which show increased antigen stability. More specifically, the invention provides stable HPV formulations comprising HPV virus-like particles (VLPs) bound to an aluminum salt adjuvant and further comprise a combination of sucrose and mannitol. The vaccine formulations of the invention are stable following freeze-thaw and freeze-drying. Also provided are lyophilized and frozen HPV vaccine formulations comprising HPV VLPs of at least one HPV type adsorbed onto an aluminum salt adjuvant, sucrose, and mannitol. Methods of making the stable vaccine formulations of the invention are also provided.
    Type: Application
    Filed: December 14, 2016
    Publication date: June 8, 2017
    Applicant: Merck Sharp & Dohme Corp.
    Inventors: Ramesh V. Chintala, Akhilesh Bhambhani