Patents by Inventor Nicholas Warne
Nicholas Warne 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).
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Patent number: 9884019Abstract: The present invention provides methods of lyophilizing a pharmaceutical substance involving a primary drying step executed at a product temperature at or above the collapse temperature. The invention also provides pharmaceutical substances lyophilized at or above the collapse temperature.Type: GrantFiled: August 5, 2009Date of Patent: February 6, 2018Assignee: Wyeth LLCInventors: Serguei Tchessalov, Dan Dixon, Nicholas Warne
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Publication number: 20120114646Abstract: The present invention provides, among other things, stable formulations for small modular immunopharmaceutical (SMIP™) proteins. In some embodiments, the present invention provides a formulation containing a lyophilized mixture of a small modular immunopharmaceutical protein, wherein less than 7% of the lyophilized small modular immunopharmaceutical protein exists in aggregated form. Formulations according to the invention may contain buffering agents, stabilizers, bulking agents, surfactants and/or other excipients. The present invention also provides formulations for lyophilization, reconstitution and methods of use thereof.Type: ApplicationFiled: June 18, 2010Publication date: May 10, 2012Applicant: WYETH LLCInventors: Serguei Tchessalov, Angela Kantor, Li Li, Nicholas Luksha, Nicholas Warne
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Publication number: 20110033464Abstract: The present invention provides compositions of Ig fusion proteins, especially compositions including an Ig fusion protein, a bulking agent, a disaccharide, a surfactant, and a buffer. In one aspect, these compositions are stable under long-term storage or at least one freeze/thaw cycle. The invention also provides methods of preparation of the Ig fusion protein compositions. In one aspect, compositions of the invention are lyophilized. In a further aspect, the compositions are lyophilized by a process that includes an annealing step.Type: ApplicationFiled: October 22, 2010Publication date: February 10, 2011Inventors: Anthony BARRY, Thomas Crowley, Daniel Dixon, Jennifer Juneau, Ajay Kumar, Li Li, Nicholas Luksha, Michael Shamashkin, Erin Soley, Nicholas Warne, Chandra Webb
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Publication number: 20100041870Abstract: The present invention provides methods of lyophilizing a pharmaceutical substance involving a primary drying step executed at a product temperature at or above the collapse temperature. The invention also provides pharmaceutical substances lyophilized at or above the collapse temperature.Type: ApplicationFiled: August 5, 2009Publication date: February 18, 2010Applicant: WyethInventors: Serguei Tchessalov, Dan Dixon, Nicholas Warne
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Publication number: 20090324586Abstract: The present invention provides methods for assessing and optimizing lyophilization cycle robustness. In particular, the present invention provides rapid assessment of cycle robustness with respect to a variety of lyophilization process deviations by varying a relatively small number of parameters.Type: ApplicationFiled: June 25, 2009Publication date: December 31, 2009Applicant: WyethInventors: Serguei Tchessalov, Daniel Dixon, Anthony Barry, Nicholas Warne
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Publication number: 20090311241Abstract: Human antibodies, preferably recombinant human antibodies, that specifically bind to human interleukin-12 (hIL-12) are disclosed. Preferred antibodies have high affinity for hIL-12 and neutralize hIL-12 activity in vitro and in vivo. An antibody of the invention can be a full-length antibody or an antigen-binding portion thereof. The antibodies, or antibody portions, of the invention are useful for detecting hIL-12 and for inhibiting hIL-12 activity, e.g., in a human subject suffering from a disorder in which hIL-12 activity is detrimental. Nucleic acids, vectors and host cells for expressing the recombinant human antibodies of the invention, and methods of synthesizing the recombinant human antibodies, are also encompassed by the invention.Type: ApplicationFiled: December 22, 2006Publication date: December 17, 2009Applicant: Abbott GMBH & Co., KGInventors: Jochen Salfeld, Michael Roguska, Michael Paskind, Subhashis Banerjee, Daniel Tracey, Michael White, Zehra Kaymakcalan, Boris Labkovsky, Paul Sakorafas, Geertruida Veldman, Amy Venturini, Angela Widom, Stuart Friedrich, Nicholas Warne, Angela Kantor, John Elvin, Alexander Duncan, Elaine Derbyshire, Sara Carmen, Stephen Smith, Thor Holtet, Sarah Du Fou
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Publication number: 20080098614Abstract: A method and apparatus for optimizing the primary drying step of a lyophilization cycle of a biological or pharmaceutical material. In one aspect, the invention is a method for lyophilizing a material comprising the steps of calculating a designed primary drying cycle for the material based on a product temperature profile for the material and modifying both a chamber pressure and a shelf temperature according to a designed primary drying cycle during a primary drying step. In another aspect, the invention is an apparatus for lyophilizing a material according to a designed primary drying cycle comprising a computer-readable medium, a processor in electrical communication with the computer-readable medium, a chamber pressure module in electrical communication with the processor, and a shelf temperature module in electrical communication with the processor.Type: ApplicationFiled: October 3, 2007Publication date: May 1, 2008Applicant: WyethInventors: Serguei Tchessalov, Nicholas Warne
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Publication number: 20080070230Abstract: Methods of formulating proteins at high concentrations in protein solutions, wherein the protein solutions lack or have reduced liquid-liquid phase separation are described. Such protein solutions are substantially clear and substantially homogenous. Additionally, methods of concentrating and purifying proteins using liquid-liquid phase separation are provided.Type: ApplicationFiled: June 11, 2007Publication date: March 20, 2008Applicant: WyethInventors: Li Li, Angela Kantor, Nicholas Warne
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Publication number: 20080064856Abstract: Methods of reducing aggregation of a protein or proteins in a formulation, and protein formulations having reduced aggregation properties are provided. The methods and formulations described herein maintain the biological activity of a protein and increase the shelf life of protein formulations.Type: ApplicationFiled: March 19, 2007Publication date: March 13, 2008Applicant: WyethInventors: Nicholas Warne, Angela Kantor, Thomas Crowley, Erin Soley, Li Li, Nicholas Luksha, Edie Neidhardt
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Publication number: 20080063634Abstract: Human antibodies, preferably recombinant human antibodies, that specifically bind to human interleukin-12 (hIL-12) are disclosed. Preferred antibodies have high affinity for hIL-12 and neutralize hIL-12 activity in vitro and in vivo. An antibody of the invention can be a full-length antibody or an antigen-binding portion thereof. The antibodies, or antibody portions, of the invention are useful for detecting hIL-12 and for inhibiting hIL-12 activity, e.g., in a human subject suffering from a disorder in which hIL-12 activity is detrimental. Nucleic acids, vectors and host cells for expressing the recombinant human antibodies of the invention, and methods of synthesizing the recombinant human antibodies, are also encompassed by the invention.Type: ApplicationFiled: December 22, 2006Publication date: March 13, 2008Applicant: Abbott GMBH & Co., KGInventors: Jochen Salfeld, Michael Roguska, Michael Paskind, Subhashis Banerjee, Daniel Tracey, Michael White, Zehra Kaymakcalan, Boris Labkovsky, Paul Sakorafas, Geertruida Veldman, Amy Venturini, Angela Widom, Stuart Friedrich, Nicholas Warne, Angela Kantor, John Elvin, Alexander Duncan, Elaine Derbyshire, Sara Carmen, Stephen Smith, Thor Holtet, Sarah Du Fou
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Publication number: 20080003686Abstract: A method is described for predicting the relative solubility of a polypeptide using polyethylene glycol (PEG) based volume exclusion precipitation. Different polypeptides can be tested for their solubilities relative to each other or relative to a reference. A single polypeptide can be tested for its relative solubility under different experimental conditions. The solubility determinations can be made by comparison based on graphs plotting the log solubility of the polypeptide against a range of PEG concentrations. Additionally, a method is provided for the high throughput visual or automated screening of multiple polypeptides for relative solubility differences, in a method that can omit the step of measuring the actual solubility or actual amount of precipitation of each sample at each PEG concentration.Type: ApplicationFiled: May 17, 2007Publication date: January 3, 2008Applicant: WyethInventors: Li Li, Angela Kantor, Nicholas Warne
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Publication number: 20070237758Abstract: The present invention provides compositions of Ig fusion proteins, especially compositions including an Ig fusion protein, a bulking agent, a disaccharide, a surfactant, and a buffer. In one aspect, these compositions are stable under long-term storage or at least one freeze/thaw cycle. The invention also provides methods of preparation of the Ig fusion protein compositions. In one aspect, compositions of the invention are lyophilized. In a further aspect, the compositions are lyophilized by a process that includes an annealing step.Type: ApplicationFiled: November 21, 2006Publication date: October 11, 2007Inventors: Anthony Barry, Thomas Crowley, Daniel Dixon, Jennifer Juneau, Ajay Kumar, Li Li, Nicholas Luksha, Michael Shamashkin, Erin Soley, Nicholas Warne, Chandra Webb
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Publication number: 20070172479Abstract: Protein formulations and methods for reducing the viscosity of a protein formulation are provided. The method for reducing the viscosity of a protein formulation comprises adding a viscosity reducing agent, such as calcium chloride or magnesium chloride to the protein formulation.Type: ApplicationFiled: December 21, 2006Publication date: July 26, 2007Applicant: WyethInventors: Nicholas Warne, Pilarin Nichols, Paulo Loueiro
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Publication number: 20060210557Abstract: The present invention provides formulations for maintaining the stability of polypeptides, in particular, therapeutic antigen-binding polypeptides such as antibodies and the like, for example, anti-A? antibodies. The formulations generally include an antioxidant in a sufficient amount as to inhibit by-product formation, for example, the formation of high molecular weight polypeptide aggregates, low molecular weight polypeptide degradation fragments, and mixtures thereof. The formulations of the invention optionally comprise a tonicity agent, such as mannitol, and a buffering agent or amino acid such as histidine, and thus, the formulations are suitable for several different routes of administration.Type: ApplicationFiled: January 27, 2006Publication date: September 21, 2006Inventors: Donna Luisi, Nicholas Warne, Angela Kantor
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Publication number: 20060193850Abstract: The present invention provides formulations for maintaining the stability of A? binding polypeptides, for example, A? antibodies. Exemplary formulations include a tonicity agent such as mannitol and a buffering agent or amino acid such as histidine. Other exemplary formulations include an antioxidant in a sufficient amount as to inhibit by-product formation, for example, the formation of high molecular weight polypeptide aggregates, low molecular weight polypeptide degradation fragments, and mixtures thereof. The formulations of the invention optionally comprise a tonicity agent, such as mannitol, and a buffering agent or amino acid such as histidine. The formulations are suitable for several different routes of administration.Type: ApplicationFiled: January 27, 2006Publication date: August 31, 2006Inventors: Nicholas Warne, Donna Luisi, Angela Kantor
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Publication number: 20060159656Abstract: Provided by the present invention are novel compositions and methods for obtaining concentrated preparations of IL-11 and formulations of IL-11 suitable for storage and administration.Type: ApplicationFiled: December 28, 2005Publication date: July 20, 2006Applicant: American Home Products Corp.Inventors: Nicholas Warne, Rebecca Ingram, Shannon MacMillan
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Publication number: 20060079450Abstract: The invention provides compositions containing hydroxyethyl starch and polypeptides, including therapeutic polypeptides such as interleukin-11, that provide for enhanced stability of the polypeptide following storage at room temperature or elevated temperatures.Type: ApplicationFiled: September 27, 2005Publication date: April 13, 2006Inventors: Nicholas Warne, Rebecca Koval, John Carpenter, Theodore Randolph, Suchart Chongpraset
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Publication number: 20050008580Abstract: Hemophilia treatment by the inhalation of coagulation factors. Dry powder Factor IX is aerosolized to a mass median aerodynamic diameter of 4 ?m or less, with at least 90% monomer content, at least 80% activity level, and 10% water or less. The aerosol is slowly, and deeply inhaled into the lung, and followed by a maximal exhale.Type: ApplicationFiled: April 8, 2004Publication date: January 13, 2005Applicants: Wyeth, Nektar TherapeuticsInventors: David Gong, Jayne Hastedt, Robert Schaub, Nicholas Warne, Andrew Dorner, Chandra Webb, James Keith
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Publication number: 20050004354Abstract: Human antibodies, preferably recombinant human antibodies, that specifically bind to human interleukin-12 (hIL-12) are disclosed. Preferred antibodies have high affinity for hIL-12 and neutralize hIL-12 activity in vitro and in vivo. An antibody of the invention can be a full-length antibody or an antigen-binding portion thereof. The antibodies, or antibody portions, of the invention are useful for detecting hIL-12 and for inhibiting hIL-12 activity, e.g., in a human subject suffering from a disorder in which hIL-12 activity is detrimental. Nucleic acids, vectors and host cells for expressing the recombinant human antibodies of the invention, and methods of synthesizing the recombinant human antibodies, are also encompassed by the invention.Type: ApplicationFiled: July 1, 2004Publication date: January 6, 2005Applicant: Abbott GMBH & Co., KGInventors: Jochen Salfeld, Michael Roguska, Michael Paskind, Subhashis Banerjee, Daniel Tracey, Michael White, Zehra Kaymakcalan, Boris Labkovsky, Paul Sakorafas, Geertruida Veldman, Amy Venturini, Angela Widom, Stuart Friedrich, Nicholas Warne, Angela Myles, John Elvin, Alexander Duncan, Elaine Derbyshire, Sara Carmen, Stephen Smith, Thor Holtet, Sarah Du Fou