Patents by Inventor Bret A. Shirley

Bret A. Shirley 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: 8388942
    Abstract: Improved methods for purification and recovery of interferon-beta (IFN-?) and compositions comprising substantially monomeric IFN-? are provided. In one purification method, substantially purified IFN-? or variant thereof is precipitated and then dissolved in a guanidine hydrochloride (HCl) solution. Renaturation of the protein occurs by dilution with a suitable buffer. A similar purification method absent the precipitation step is also provided. Following renaturation of the IFN-?, residual guanidine HCl is removed by diafiltration or dialysis with a pharmaceutically acceptable buffer to prepare pharmaceutical compositions comprising substantially monomeric IFN-?.
    Type: Grant
    Filed: April 29, 2008
    Date of Patent: March 5, 2013
    Assignee: Novartis Vaccines and Diagnostics, Inc.
    Inventors: Sidney N Wolfe, Bret A Shirley, Susan Babuka, Dennis Fordham, Irina Esikova
  • Patent number: 8333958
    Abstract: Stabilized pharmaceutical compositions comprising substantially monomeric interferon-beta (IFN-?) and methods useful in their preparation are provided. The compositions comprise the IFN-? solubilized in a low-ionic-strength formulation that maintains the composition at a pH of about 3.0 to about 5.0. Methods for preparing these compositions, and for increasing solubility of IFN-? in pharmaceutical compositions, are provided.
    Type: Grant
    Filed: January 11, 2011
    Date of Patent: December 18, 2012
    Assignee: Novartis Vaccines and Diagnostics, Inc.
    Inventors: Bret A Shirley, Susan Babuka, Bao-Lu Chen, Maninder Hora, Minna Choe, Melanie Tellers
  • Publication number: 20110224138
    Abstract: Described herein are methods for using bone morphogenetic proteins (BMPs), such as OP-1 (also known as BMP-7), to treat pain caused by osteoarthritis. The methods involve administering to a patient suffering from pain caused by osteoarthritis a BMP, for example, intraarticularly by injection directly into the joint afflicted with osteoarthritis. The methods of the invention provide long-term pain relief to sufferers of osteoarthritis and can improve the functionality of the joint to which the BMP is administered.
    Type: Application
    Filed: September 9, 2010
    Publication date: September 15, 2011
    Inventors: Julie Krop, Marilyn Pike, Dean Falb, Bret Shirley, Denis Schrier, Mary Elizabeth Goad
  • Publication number: 20110104116
    Abstract: Stabilized pharmaceutical compositions comprising substantially monomeric interferon-beta (IFN-?) and methods useful in their preparation are provided. The compositions comprise the IFN-? solubilized in a low-ionic-strength formulation that maintains the composition at a pH of about 3.0 to about 5.0. Methods for preparing these compositions, and for increasing solubility of IFN-? in pharmaceutical compositions, are provided.
    Type: Application
    Filed: January 11, 2011
    Publication date: May 5, 2011
    Inventors: Bret A. Shirley, Susan Babuka, Bao-Lu Chen, Maninder Hora, Minna Choe, Melanie Tellers
  • Patent number: 7892531
    Abstract: Stabilized pharmaceutical compositions comprising substantially monomeric interferon-beta (IFN-?) and methods useful in their preparation are provided. The compositions comprise the IFN-? solubilized in a low-ionic-strength formulation that maintains the composition at a pH of about 3.0 to about 5.0. Methods for preparing these compositions, and for increasing solubility of IFN-? in pharmaceutical compositions, are provided.
    Type: Grant
    Filed: April 9, 2008
    Date of Patent: February 22, 2011
    Assignee: Novartis Vaccines and Diagnostics
    Inventors: Bret A Shirley, Susan Babuka, Bao-Lu Chen, Maninder Hora, Minna Choe, Melanie Tellers
  • Patent number: 7754686
    Abstract: Stabilized FGF compositions are provided. The compositions comprise FGF or variant thereof and at least one reducing agent in an amount sufficient to inhibit FGF oxidation. Methods for increasing stability of FGF or variant thereof in a liquid or lyophilized composition and for increasing storage stability of such a composition are also provided.
    Type: Grant
    Filed: August 31, 2001
    Date of Patent: July 13, 2010
    Assignee: Novartis Vaccines and Diagnostics, Inc.
    Inventors: Robert V. Hageman, Bret A. Shirley, Kamaljit K. Bajwa
  • Patent number: 7544354
    Abstract: Improved methods for purification and recovery of interferon-beta (IFN-?) and compositions comprising substantially monomeric IFN-? are provided. In one purification method, substantially purified IFN-? or variant thereof is precipitated and then dissolved in a guanidine hydrochloride (HCl) solution. Renaturation of the protein occurs by dilution with a suitable buffer. A similar purification method absent the precipitation step is also provided. Following renaturation of the IFN-?, residual guanidine HCl is removed by diafiltration or dialysis with a pharmaceutically acceptable buffer to prepare pharmaceutical compositions comprising substantially monomeric IFN-?.
    Type: Grant
    Filed: October 25, 2001
    Date of Patent: June 9, 2009
    Assignee: Novartis Vaccines and Diagnostics
    Inventors: Sidney N. Wolfe, Bret A. Shirley, Susan Babuka, Dennis Fordham, Irina Esikova
  • Publication number: 20090123424
    Abstract: Improved methods for purification and recovery of interferon-beta (IFN-?) and compositions comprising substantially monomeric IFN-? are provided. In one purification method, substantially purified IFN-? or variant thereof is precipitated and then dissolved in a guanidine hydrochloride (HCl) solution. Renaturation of the protein occurs by dilution with a suitable buffer. A similar purification method absent the precipitation step is also provided. Following renaturation of the IFN-? residual guanidine HCl is removed by diafiltration or dialysis with a pharmaceutically acceptable buffer to prepare pharmaceutical compositions comprising substantially monomeric IFN-?.
    Type: Application
    Filed: April 29, 2008
    Publication date: May 14, 2009
    Inventors: Sidney N. Wolfe, Bret A. Shirley, Susan Babuka, Dennis Fordham, Irina Esikova
  • Publication number: 20080293624
    Abstract: Stabilized FGF compositions are provided. The compositions comprise FGF or variant thereof and at least one reducing agent in an amount sufficient to inhibit FGF oxidation. Methods for increasing stability of FGF or variant thereof in a liquid or lyophilized composition and for increasing storage stability of such a composition are also provided.
    Type: Application
    Filed: August 31, 2001
    Publication date: November 27, 2008
    Inventors: Robert V. Hageman, Bret A. Shirley, Kamaljit K. Bajwa
  • Publication number: 20080193415
    Abstract: Stabilized pharmaceutical compositions comprising substantially monomeric interferon-beta (IFN-?) and methods useful in their preparation are provided. The compositions comprise the IFN-? solubilized in a low-ionic-strength formulation that maintains the composition at a pH of about 3.0 to about 5.0. Methods for preparing these compositions, and for increasing solubility of IFN-? in pharmaceutical compositions, are provided.
    Type: Application
    Filed: April 9, 2008
    Publication date: August 14, 2008
    Inventors: Bret A. Shirley, Susan Babuka, Bao-Lu Chen, Maninder Hora, Minna Choe, Melanie Tellers
  • Publication number: 20080171071
    Abstract: A highly concentrated, low salt-containing, biologically active syrup form of IGF-I or variant thereof and methods for its preparation are provided. This novel syrup form of IGF-I has an IGF-I concentration of at least about 250 mg/ml, a density of about 1.0 g/ml to about 1.2 g/ml, and a viscosity of about 13,000 centipoise (cps) to about 19,000 cps, as measured at ambient temperature (23° C.). The IGF-I syrup is prepared by precipitating or partitioning IGF-I from solution, preferably by adjusting the solution pH or by use of a solubility enhancer to concentrate IGF-I in solution followed by removal of the solubility enhancer. The precipitated syrup is useful as a means of storing IGF-I in a stable form and as a means of preparing compositions comprising biologically active IGF-I. Pharmaceutical compositions and kits comprising this concentrated IGF-I syrup are provided.
    Type: Application
    Filed: December 17, 2007
    Publication date: July 17, 2008
    Applicant: Chiron Corporation
    Inventors: Bret A. Shirley, Maninder S. Hora
  • Patent number: 7399463
    Abstract: Stabilized pharmaceutical compositions comprising substantially monomeric interferon-beta (IFN-?) and methods useful in their preparation are provided. The compositions comprise the IFN-? solubilized in a low-ionic-strength formulation that maintains the composition at a pH of about 3.0 to about 5.0. Methods for preparing these compositions, and for increasing solubility of IFN-? in pharmaceutical compositions, are provided.
    Type: Grant
    Filed: April 9, 2004
    Date of Patent: July 15, 2008
    Assignee: Novartis Vaccines and Diagnostics, Inc.
    Inventors: Bret A. Shirley, Susan Babuka, Bao-Lu Chen, Maninder Hora, Minna Choe, Melanie Tellers
  • Patent number: 7371373
    Abstract: Stabilized pharmaceutical compositions comprising substantially monomeric interferon-beta (IFN-?) and methods useful in their preparation are provided. The compositions comprise the IFN-? solubilized in a low-ionic-strength formulation that maintains the composition at a pH of about 3.0 to about 5.0. Methods for preparing these compositions, and for increasing solubility of IFN-? in pharmaceutical compositions, are provided.
    Type: Grant
    Filed: February 18, 2005
    Date of Patent: May 13, 2008
    Assignee: Novartis Vaccines and Diagnostics, Inc.
    Inventors: Bret A. Shirley, Susan Babuka, Bao-Lu Chen, Maninder Hora, Minna Choe, Melanie Tellers
  • Patent number: 7335639
    Abstract: A highly concentrated, low salt-containing, biologically active syrup form of IGF-I or variant thereof and methods for its preparation are provided. This novel syrup form of IGF-I has an IGF-I concentration of at least about 250 mg/ml, a density of about 1.0 g/ml to about 1.2 g/ml, and a viscosity of about 13,000 centipoise (cps) to about 19,000 cps, as measured at ambient temperature (23° C.). The IGF-I syrup is prepared by precipitating or partitioning IGF-I from solution, preferably by adjusting the solution pH or by use of a solubility enhancer to concentrate IGF-I in solution followed by removal of the solubility enhancer. The precipitated syrup is useful as a means of storing IGF-I in a stable form and as a means of preparing compositions comprising biologically active IGF-I. Pharmaceutical compositions and kits comprising this concentrated IGF-I syrup are provided.
    Type: Grant
    Filed: August 2, 2005
    Date of Patent: February 26, 2008
    Assignee: Novartis Vaccines and Diagnostics, Inc.
    Inventors: Bret A. Shirley, Maninder S. Hora
  • Publication number: 20070249522
    Abstract: The invention is directed to formulations of a pharmaceutically active agent for in vivo use. The formulations to which the invention is directed are designed to minimize the pain associated with components in injectable formulations, other than the pharmaceutically active agent. The invention is particularly directed to buffers that provide for minimum pain upon injection. Insulin-like growth factor I (IGF-I) is a preferred pharmaceutically active agent.
    Type: Application
    Filed: July 3, 2007
    Publication date: October 25, 2007
    Applicant: Novartis Vaccines & Diagnostics, Inc.
    Inventors: Bret Shirley, Maninder Hora
  • Patent number: 7262168
    Abstract: Novel IGF-I compositions are described. The compositions include a solubilizing compound comprising a guanidinium group that provides for IGF-I compositions in which IGF-I is highly soluble at pHs of about 5.5 or greater and at refrigerated temperatures.
    Type: Grant
    Filed: September 19, 2005
    Date of Patent: August 28, 2007
    Assignee: Chiron Corporation
    Inventors: Bret A. Shirley, Kamaljit Bajwa
  • Patent number: 7067485
    Abstract: A highly concentrated, low salt-containing, biologically active syrup form of IGF-I or variant thereof and methods for its preparation are provided. This novel syrup form of IGF-I has an IGF-I concentration of at least about 250 mg/ml, a density of about 1.0 g/ml to about 1.2 g/ml, and a viscosity of about 13,000 centipoise (cps) to about 19,000 cps, as measured at ambient temperature (23° C.). The IGF-I syrup is prepared by precipitating or partitioning IGF-I from solution, preferably by adjusting the solution pH or by use of a solubility enhancer to concentrate IGF-I in solution followed by removal of the solubility enhancer. The precipitated syrup is useful as a means of storing IGF-I in a stable form and as a means of preparing compositions comprising biologically active IGF-I. Pharmaceutical compositions and kits comprising this concentrated IGF-I syrup are provided.
    Type: Grant
    Filed: November 6, 1998
    Date of Patent: June 27, 2006
    Assignee: Chiron Corporation
    Inventors: Bret A. Shirley, Maninder S. Hora
  • Publication number: 20060074011
    Abstract: Novel IGF-I compositions are described. The compositions include a solubilizing compound comprising a guanidinium group that provides for IGF-I compositions in which IGF-I is highly soluble at pHs of about 5.5 or greater and at refrigerated temperatures.
    Type: Application
    Filed: September 19, 2005
    Publication date: April 6, 2006
    Applicant: Chiron Corporation
    Inventors: Bret Shirley, Kamaljit Bajwa
  • Publication number: 20050266046
    Abstract: A highly concentrated, low salt-containing, biologically active syrup form of IGF-I or variant thereof and methods for its preparation are provided. This novel syrup form of IGF-I has an IGF-I concentration of at least about 250 mg/ml, a density of about 1.0 g/ml to about 1.2 g/ml, and a viscosity of about 13,000 centipoise (cps) to about 19,000 cps, as measured at ambient temperature (23° C.). The IGF-I syrup is prepared by precipitating or partitioning IGF-I from solution, preferably by adjusting the solution pH or by use of a solubility enhancer to concentrate IGF-I in solution followed by removal of the solubility enhancer. The precipitated syrup is useful as a means of storing IGF-I in a stable form and as a means of preparing compositions comprising biologically active IGF-I. Pharmaceutical compositions and kits comprising this concentrated IGF-I syrup are provided.
    Type: Application
    Filed: August 2, 2005
    Publication date: December 1, 2005
    Applicant: Chiron Corporation
    Inventors: Bret Shirley, Maninder Hora
  • Patent number: 6951842
    Abstract: Novel IGF-I compositions are described. The compositions include a solubilizing compound comprising a guanidinium group that provides for IGF-I compositions in which IGF-I is highly soluble at pHs of about 5.5 or greater and at refrigerated temperatures.
    Type: Grant
    Filed: May 11, 2004
    Date of Patent: October 4, 2005
    Assignee: Chiron Corporation
    Inventors: Bret A. Shirley, Kamaljit Bajwa