Patents by Inventor Serguei A. Tchessalov
Serguei A. Tchessalov 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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Publication number: 20240041785Abstract: The present disclosure provides technologies relating to stabilization of lipid nanoparticle mRNA compositions (e.g., vaccines).Type: ApplicationFiled: November 14, 2021Publication date: February 8, 2024Inventors: Steffen Panzner, Christian Reinsch, Kaushik Thanki, Sukrut Somani, Serguei A. Tchessalov, Bakul Subodh Bhatnagar, Ramin Darvari, Sumit Luthra
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Publication number: 20230414747Abstract: The present disclosure relates generally to the field of lipid nanoparticle (LNP) compositions comprising RNA, methods for preparing and storing such compositions, and the use of such compositions in therapy.Type: ApplicationFiled: November 15, 2021Publication date: December 28, 2023Inventors: Steffen Panzner, Ugur Sahin, Jorrit-Jan Krijger, Kaushik Thanki, Bakul Subodh Bhatnagar, Ramin Darvari, Sumit Luthra, Serguei A. Tchessalov
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Publication number: 20230414516Abstract: This invention relates to enhanced stabilization and improved lyophilization methods of pharmaceutical substances.Type: ApplicationFiled: November 15, 2021Publication date: December 28, 2023Inventors: Bakul Subodh Bhatnagar, Ramin Darvari, Sumit Luthra, Serguei A. Tchessalov, Steffen Panzner, Christian Reinsch, Kaushik Thanki, Sukrut Somani
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Patent number: 11020459Abstract: A Factor VIII (FVIII) composition formulated such that NaCl is not present in the final formulation or is present in trace amounts, which allows for a concomitant reduction in the lyophilization cycle time and increased stability of the lyophilized FVIII.Type: GrantFiled: August 21, 2019Date of Patent: June 1, 2021Assignees: Baxalta Incorporated, Baxalta GmbH, University of ConnecticutInventors: Michael Pikal, Serguei Tchessalov, Erik Bjornson, Feroz Jameel, Marc Besman
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Publication number: 20200078447Abstract: A Factor VIII (FVIII) composition formulated such that NaCl is not present in the final formulation or is present in trace amounts, which allows for a concomitant reduction in the lyophilization cycle time and increased stability of the lyophilized FVIII.Type: ApplicationFiled: August 21, 2019Publication date: March 12, 2020Inventors: Michael Pikal, Serguei Tchessalov, Erik Bjornson, Feroz Jameel, Marc Besman
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Patent number: 10512674Abstract: A Factor VIII (FVIII) composition formulated such that NaCl is not present in the final formulation or is present in trace amounts, which allows for a concomitant reduction in the lyophilization cycle time and increased stability of the lyophilized FVIII.Type: GrantFiled: May 3, 2016Date of Patent: December 24, 2019Inventors: Michael Pikal, Serguei Tchessalov, Erik Bjornson, Feroz Jameel, Marc Besman
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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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Patent number: 9669076Abstract: A Factor VIII composition formulated without albumin, comprising the following formulation excipients in addition to Factor VIII: 4% to 10% of a bulking agent selected from the group consisting of mannitol, glycine and alanine; 1% to 4% of a stabilizing agent selected from the group consisting of sucrose, trehalose, raffinose, and arginine; 1 mM to 5 mM calcium salt; 100 mM to 300 mM NaCl; and a buffering agent for maintaining a pH of approximately between 6 and 8. Alternatively, the formulation can comprise 2% to 6% hydroxyethyl starch; 1% to 4% of a stabilizing agent selected from the group consisting of sucrose, trehalose, raffinose, and arginine; 1 mM to 5 mM calcium salt; 100 mM to 300 mM NaCl; and a buffering agent for maintaining a pH of approximately between 6 and 8.Type: GrantFiled: May 4, 2016Date of Patent: June 6, 2017Assignees: Baxalta Incorporated, Baxalta GmbH, University of ConnecticutInventors: Marc Besman, Erik Bjornson, Feroz Jameel, Ramesh Kashi, Michael Pikal, Serguei Tchessalov, John Carpenter
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Publication number: 20170087218Abstract: A Factor VIII (FVIII) composition formulated such that NaCl is not present in the final formulation or is present in trace amounts, which allows for a concomitant reduction in the lyophilization cycle time and increased stability of the lyophilized FVIII.Type: ApplicationFiled: May 3, 2016Publication date: March 30, 2017Inventors: Michael Pikal, Serguei Tchessalov, Erik Bjornson, Feroz Jameel, Marc Besman
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Publication number: 20170000854Abstract: A Factor VIII composition formulated without albumin, comprising the following formulation excipients in addition to Factor VIII: 4% to 10% of a bulking agent selected from the group consisting of mannitol, glycine and alanine; 1% to 4% of a stabilizing agent selected from the group consisting of sucrose, trehalose, raffinose, and arginine; 1 mM to 5 mM calcium salt; 100 mM to 300 mM NaCl; and a buffering agent for maintaining a pH of approximately between 6 and 8. Alternatively, the formulation can comprise 2% to 6% hydroxyethyl starch; 1% to 4% of a stabilizing agent selected from the group consisting of sucrose, trehalose, raffinose, and arginine; 1 mM to 5 mM calcium salt; 100 mM to 300 mM NaCl; and a buffering agent for maintaining a pH of approximately between 6 and 8.Type: ApplicationFiled: May 4, 2016Publication date: January 5, 2017Inventors: Marc Besman, Erik Bjornson, Feroz Jameel, Ramesh Kashi, Michael Pikal, Serguei Tchessalov, John Carpenter
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Patent number: 9352027Abstract: A Factor VIII composition formulated without albumin, comprising the following formulation excipients in addition to Factor VIII: 4% to 10% of a bulking agent selected from the group consisting of mannitol, glycine and alanine; 1% to 4% of a stabilizing agent selected from the group consisting of sucrose, trehalose, raffinose, and arginine; 1 mM to 5 mM calcium salt; 100 mM to 300 mM NaCl; and a buffering agent for maintaining a pH of approximately between 6 and 8. Alternatively, the formulation can comprise 2% to 6% hydroxyethyl starch; 1% to 4% of a stabilizing agent selected from the group consisting of sucrose, trehalose, raffinose, and arginine; 1 mM to 5 mM calcium salt; 100 mM to 300 mM NaCl; and a buffering agent for maintaining a pH of approximately between 6 and 8.Type: GrantFiled: May 23, 2014Date of Patent: May 31, 2016Assignees: Baxalta Incorporated, Baxalta GmbH, University of ConnecticutInventors: Marc Besman, Erik Bjornson, Feroz Jameel, Ramesh Kashi, Michael Pikal, Serguei Tchessalov, John Carpenter
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Publication number: 20150025010Abstract: A Factor VIII composition formulated without albumin, comprising the following formulation excipients in addition to Factor VIII: 4% to 10% of a bulking agent selected from the group consisting of mannitol, glycine and alanine; 1% to 4% of a stabilizing agent selected from the group consisting of sucrose, trehalose, raffinose, and arginine; 1 mM to 5 mM calcium salt; 100 mM to 300 mM NaCl; and a buffering agent for maintaining a pH of approximately between 6 and 8. Alternatively, the formulation can comprise 2% to 6% hydroxyethyl starch; 1% to 4% of a stabilizing agent selected from the group consisting of sucrose, trehalose, raffinose, and arginine; 1 mM to 5 mM calcium salt; 100 mM to 300 mM NaCl; and a buffering agent for maintaining a pH of approximately between 6 and 8.Type: ApplicationFiled: May 23, 2014Publication date: January 22, 2015Applicant: University of ConnecticutInventors: Marc Besman, Erik Bjornson, Feroz Jameel, Ramesh Kashi, Michael Pikal, Serguei Tchessalov, John Carpenter
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Patent number: 8765665Abstract: A Factor VIII composition formulated without albumin, comprising the following formulation excipients in addition to Factor VIII: 4% to 10% of a bulking agent selected from the group consisting of mannitol, glycine and alanine; 1% to 4% of a stabilizing agent selected from the group consisting of sucrose, trehalose, raffinose, and arginine; 1 mM to 5 mM calcium salt; 100 mM to 300 mM NaCl; and a buffering agent for maintaining a pH of approximately between 6 and 8. Alternatively, the formulation can comprise 2% to 6% hydroxyethyl starch; 1% to 4% of a stabilizing agent selected from the group consisting of sucrose, trehalose, raffinose, and arginine; 1 mM to 5 mM calcium salt; 100 mM to 300 mM NaCl; and a buffering agent for maintaining a pH of approximately between 6 and 8.Type: GrantFiled: February 6, 2013Date of Patent: July 1, 2014Assignees: Baxter International Inc., University of ConnecticutInventors: Marc Besman, Erik Bjornson, Feroz Jameel, Ramesh Kashi, Michael Pikal, Serguei Tchessalov, John Carpenter
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Patent number: 8372800Abstract: An albumin-free Factor VIII formulation comprising: 4% to 10% of a bulking agent selected from the group consisting of mannitol, glycine and alanine; 1% to 4% of a stabilizing agent selected from the group consisting of sucrose, trehalose, raffinose, and arginine; 1 mM to 5 mM calcium salt; 100 mM to 300 mM NaCl; and a buffering agent. Alternatively, the formulation can comprise 2% to 6% hydroxyethyl starch; 1% to 4% of a stabilizing agent selected from the group consisting of sucrose, trehalose, raffinose, and arginine; 1 mM to 5 mM calcium salt; 100 mM to 300 mM NaCl; and a buffering agent. In a further embodiment, the formulation can comprise: 300 mM to 500 mM NaCl; 1% to 4% of a stabilizing agent selected from the group consisting of sucrose, trehalose, raffinose, and arginine; 1 mM to 5 mM calcium salt; and a buffering agent.Type: GrantFiled: September 30, 2011Date of Patent: February 12, 2013Assignees: Baxter International Inc., University of ConnecticutInventors: Marc Besman, Erik Bjornson, Feroz Jameel, Ramesh Kashi, Michael Pikal, Serguei Tchessalov, John Carpenter
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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: 20120083446Abstract: An albumin-free Factor VIII formulation comprising, 4% to 10% of a bulking agent selected from the group consisting of mannitol, glycine and alanine; 1% to 4% of a stabilizing agent selected from the group consisting of sucrose, trehalose, raffinose, and arginine; 1 mM to 5 mM calcium salt; 100 mM to 300 mM NaCl; and a buffering agent Alternatively, the formulation can comprise 2% to 6% hydroxyethyl starch; 1% to 4% of a stabilizing agent selected from the group consisting of sucrose, trehalose, raffinose, and arginine; 1 mM to 5 mM calcium salt; 100 mM to 300 mM NaCl; and a buffering agent. In a further embodiment, the formulation can comprise: 300 mM to 500 mM NaCl; 1% to 4% of a stabilizing agent selected from the group consisting of sucrose, trehalose, raffinose, and arginine; 1 mM to 5 mM calcium salt; and a buffering agent.Type: ApplicationFiled: September 30, 2011Publication date: April 5, 2012Applicants: University of Connecticut, Baxter International Inc.Inventors: Marc Besman, Erik Bjornson, Feroz Jameel, Ramesh Kashi, Michael Pikal, Serguei Tchessalov, John Carpenter
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Patent number: 8058226Abstract: A Factor VIII composition formulated without albumin, comprising the following formulation excipients in addition to Factor VIII: 4% to 10% of a bulking agent selected from the group consisting of mannitol, glycine and alanine; 1% to 4% of a stabilizing agent selected from the group consisting of sucrose, trehalose, raffinose, and arginine; 1 mM to 5 mM calcium salt; 100 mM to 300 mM NaCl; and a buffering agent for maintaining a pH of approximately between 6 and 8. Alternatively, the formulation can comprise 2% to 6% hydroxyethyl starch; 1% to 4% of a stabilizing agent selected from the group consisting of sucrose, trehalose, raffinose, and arginine; 1 mM to 5 mM calcium salt; 100 mM to 300 mM NaCl; and a buffering agent for maintaining a pH of approximately between 6 and 8.Type: GrantFiled: June 18, 2007Date of Patent: November 15, 2011Assignees: Baxter International Inc., University of ConnecticutInventors: Marc Besman, Erik Bjornson, Feroz Jameel, Ramesh Kashi, Michael Pikal, Serguei Tchessalov, John Carpenter
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Publication number: 20100168018Abstract: A Factor VIII (FVIII) composition formulated such that NaCl is not present in the final formulation or is present in trace amounts, which allows for a concomitant reduction in the lyophilization cycle time and increased stability of the lyophilized FVIII.Type: ApplicationFiled: November 6, 2009Publication date: July 1, 2010Applicants: BAXTER INTERNATIONAL INC., UNIVERSITY OF CONNECTICUTInventors: Michael Pikal, Serguei Tchessalov, Erik Bjornson, Feroz Jameel, Marc Besman
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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