SG10201808249VA - Lyophilized factor ix formulations - Google Patents
Lyophilized factor ix formulationsInfo
- Publication number
- SG10201808249VA SG10201808249VA SG10201808249VA SG10201808249VA SG10201808249VA SG 10201808249V A SG10201808249V A SG 10201808249VA SG 10201808249V A SG10201808249V A SG 10201808249VA SG 10201808249V A SG10201808249V A SG 10201808249VA SG 10201808249V A SG10201808249V A SG 10201808249VA
- Authority
- SG
- Singapore
- Prior art keywords
- fix
- formulations
- polypeptide
- factor
- present
- Prior art date
Links
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K38/00—Medicinal preparations containing peptides
- A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
- A61K38/43—Enzymes; Proenzymes; Derivatives thereof
- A61K38/46—Hydrolases (3)
- A61K38/48—Hydrolases (3) acting on peptide bonds (3.4)
- A61K38/482—Serine endopeptidases (3.4.21)
- A61K38/4846—Factor VII (3.4.21.21); Factor IX (3.4.21.22); Factor Xa (3.4.21.6); Factor XI (3.4.21.27); Factor XII (3.4.21.38)
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
- A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
- A61K47/183—Amino acids, e.g. glycine, EDTA or aspartame
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/22—Heterocyclic compounds, e.g. ascorbic acid, tocopherol or pyrrolidones
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A61K9/19—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles lyophilised, i.e. freeze-dried, solutions or dispersions
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P7/00—Drugs for disorders of the blood or the extracellular fluid
- A61P7/04—Antihaemorrhagics; Procoagulants; Haemostatic agents; Antifibrinolytic agents
-
- C—CHEMISTRY; METALLURGY
- C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
- C12Y—ENZYMES
- C12Y304/00—Hydrolases acting on peptide bonds, i.e. peptidases (3.4)
- C12Y304/21—Serine endopeptidases (3.4.21)
- C12Y304/21022—Coagulation factor IXa (3.4.21.22)
-
- F—MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
- F26—DRYING
- F26B—DRYING SOLID MATERIALS OR OBJECTS BY REMOVING LIQUID THEREFROM
- F26B5/00—Drying solid materials or objects by processes not involving the application of heat
- F26B5/04—Drying solid materials or objects by processes not involving the application of heat by evaporation or sublimation of moisture under reduced pressure, e.g. in a vacuum
- F26B5/06—Drying solid materials or objects by processes not involving the application of heat by evaporation or sublimation of moisture under reduced pressure, e.g. in a vacuum the process involving freezing
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Engineering & Computer Science (AREA)
- General Health & Medical Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Epidemiology (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Organic Chemistry (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- General Engineering & Computer Science (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Molecular Biology (AREA)
- Biochemistry (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Mechanical Engineering (AREA)
- Gastroenterology & Hepatology (AREA)
- Wood Science & Technology (AREA)
- Zoology (AREA)
- Genetics & Genomics (AREA)
- Immunology (AREA)
- Dermatology (AREA)
- Diabetes (AREA)
- Hematology (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Medicinal Preparation (AREA)
- Peptides Or Proteins (AREA)
- Medicines Containing Material From Animals Or Micro-Organisms (AREA)
Abstract
LYOPHILIZED FACTOR IX FORMULATIONS The present invention provides, among other things, pre-tyophilization formulations, reconstituted formulations, and lyophilate powder compositions comprising a Factor IX (FIX) polypeptide. The present invention also provides lyophilization methods for producing lyophilate powder comprising a FIX polypeptide.The present invention is directed to a pre- tyophilization formulation comprising: (a) a Factor IX (FIX) polypeptide having FIX coagulation activity; (b) a buffering agent; (c) a stabilizing agent; (d) a bulking agent; and (e) a surfactant, wherein the formulation has a fill volume of less than about 5 mL,and wherein each of (a) - (e) are at an amount per vial (mg/vial) sufficient to allow (1) improved stability of the FIX polypeptide when lyophilized. Fig. 1
Applications Claiming Priority (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US201461969801P | 2014-03-24 | 2014-03-24 |
Publications (1)
Publication Number | Publication Date |
---|---|
SG10201808249VA true SG10201808249VA (en) | 2018-10-30 |
Family
ID=54196282
Family Applications (3)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
SG10201808249VA SG10201808249VA (en) | 2014-03-24 | 2015-03-24 | Lyophilized factor ix formulations |
SG10201913735SA SG10201913735SA (en) | 2014-03-24 | 2015-03-24 | Lyophilized factor ix formulations |
SG11201607642RA SG11201607642RA (en) | 2014-03-24 | 2015-03-24 | Lyophilized factor ix formulations |
Family Applications After (2)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
SG10201913735SA SG10201913735SA (en) | 2014-03-24 | 2015-03-24 | Lyophilized factor ix formulations |
SG11201607642RA SG11201607642RA (en) | 2014-03-24 | 2015-03-24 | Lyophilized factor ix formulations |
Country Status (16)
Country | Link |
---|---|
US (2) | US10772942B2 (en) |
EP (1) | EP3123090A4 (en) |
JP (4) | JP7058940B2 (en) |
KR (1) | KR102385372B1 (en) |
AR (1) | AR099838A1 (en) |
AU (3) | AU2015236340B2 (en) |
CA (1) | CA2943034C (en) |
CL (1) | CL2016002386A1 (en) |
EA (2) | EA038573B1 (en) |
IL (3) | IL247869B (en) |
MA (1) | MA39779A (en) |
MX (2) | MX2016012447A (en) |
PH (1) | PH12016501877A1 (en) |
SG (3) | SG10201808249VA (en) |
TW (1) | TWI700101B (en) |
WO (1) | WO2015148444A1 (en) |
Families Citing this family (6)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
EP2968498A4 (en) * | 2013-03-15 | 2016-09-07 | Biogen Ma Inc | Factor ix polypeptide formulations |
EA038573B1 (en) * | 2014-03-24 | 2021-09-16 | Биовератив Терапьютикс Инк. | Lyophilized factor ix formulation for preventing bleeding episodes |
CA3069444A1 (en) * | 2017-07-11 | 2019-01-17 | Universal Stabilization Technologies, Inc. | Method for preserving biopharmaceuticals |
CN112175088B (en) * | 2019-07-02 | 2023-03-28 | 江苏晟斯生物制药有限公司 | FIX fusion proteins, conjugates and uses thereof |
MX2022009558A (en) * | 2020-02-04 | 2022-09-09 | Regeneron Pharma | Target residual moisture content for lyophilized drug product. |
CA3172874A1 (en) * | 2020-05-11 | 2021-11-18 | Alkermes Pharma Ireland Limited | Il-2 fusion polypeptide compositions and methods of making and using the same |
Family Cites Families (52)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
DE3572982D1 (en) | 1984-03-06 | 1989-10-19 | Takeda Chemical Industries Ltd | Chemically modified lymphokine and production thereof |
WO1990006952A1 (en) | 1988-12-22 | 1990-06-28 | Kirin-Amgen, Inc. | Chemically modified granulocyte colony stimulating factor |
DE69029799T2 (en) | 1989-02-21 | 1997-05-28 | Washington University, St. Louis, Mo. | MODIFIED FORMS OF REPRODUCTION HORMONES |
US6552170B1 (en) | 1990-04-06 | 2003-04-22 | Amgen Inc. | PEGylation reagents and compounds formed therewith |
DK0575545T3 (en) | 1991-03-15 | 2003-09-15 | Amgen Inc | Pegylation of polypeptides |
FR2686899B1 (en) | 1992-01-31 | 1995-09-01 | Rhone Poulenc Rorer Sa | NOVEL BIOLOGICALLY ACTIVE POLYPEPTIDES, THEIR PREPARATION AND PHARMACEUTICAL COMPOSITIONS CONTAINING THEM. |
EP0627924B1 (en) * | 1992-10-02 | 2000-12-27 | Genetics Institute, Inc. | Composition comprising coagulation factor viii formulation, process for its preparation and use of a surfactant as stabilizer |
DE4405426A1 (en) * | 1994-02-21 | 1995-08-24 | Boehringer Mannheim Gmbh | Pharmaceutical preparation containing plasminogen activator (t-PA) or its derivatives |
US6372716B1 (en) | 1994-04-26 | 2002-04-16 | Genetics Institute, Inc. | Formulations for factor IX |
US6685940B2 (en) | 1995-07-27 | 2004-02-03 | Genentech, Inc. | Protein formulation |
US5770700A (en) | 1996-01-25 | 1998-06-23 | Genetics Institute, Inc. | Liquid factor IX formulations |
IN184589B (en) | 1996-10-16 | 2000-09-09 | Alza Corp | |
JP2001151694A (en) | 1999-09-17 | 2001-06-05 | Takeda Chem Ind Ltd | Method for producing protein powder |
WO2001021187A1 (en) * | 1999-09-17 | 2001-03-29 | Takeda Chemical Industries, Ltd. | Process for producing protein powder |
ATE336514T1 (en) | 2000-02-11 | 2006-09-15 | Merck Patent Gmbh | INCREASE THE CIRCULATION HALF-LIFE OF ANTIBODIES-BASED FUSION PROTEINS |
WO2002040544A2 (en) | 2000-11-14 | 2002-05-23 | Board Of Regents, University Of Texas Systems | Mutant human factor ix with an increased resistance to inhibition by heparin |
WO2003020764A2 (en) | 2001-09-04 | 2003-03-13 | Merck Patent Gmbh | Modified factor ix |
EP2990417A1 (en) | 2001-12-21 | 2016-03-02 | Human Genome Sciences, Inc. | Albumin insulin fusion protein |
US7348004B2 (en) | 2003-05-06 | 2008-03-25 | Syntonix Pharmaceuticals, Inc. | Immunoglobulin chimeric monomer-dimer hybrids |
TWI353991B (en) * | 2003-05-06 | 2011-12-11 | Syntonix Pharmaceuticals Inc | Immunoglobulin chimeric monomer-dimer hybrids |
EP3552627A1 (en) | 2003-05-06 | 2019-10-16 | Bioverativ Therapeutics Inc. | Clotting factor-fc chimeric proteins to treat hemophilia |
JP2005060378A (en) | 2003-07-28 | 2005-03-10 | Yamanouchi Pharmaceut Co Ltd | Freeze-dried preparation containing physiologically active protein |
US20050152979A1 (en) | 2003-09-05 | 2005-07-14 | Cell Therapeutics, Inc. | Hydrophobic drug compositions containing reconstitution enhancer |
JP2007526329A (en) | 2004-03-04 | 2007-09-13 | ワイス | Freeze-drying method to improve excipient crystallization |
WO2006029467A1 (en) * | 2004-09-16 | 2006-03-23 | Btf Pty Ltd | Rapid freeze drying process |
WO2006053299A2 (en) | 2004-11-12 | 2006-05-18 | Bayer Healthcare Llc | Site-directed modification of fviii |
US8367805B2 (en) | 2004-11-12 | 2013-02-05 | Xencor, Inc. | Fc variants with altered binding to FcRn |
AU2006272804B2 (en) * | 2005-07-22 | 2011-02-24 | Amgen Inc. | Concentrated protein lyophilates, methods, and uses |
WO2007044616A2 (en) * | 2005-10-06 | 2007-04-19 | Xencor, Inc. | Optimized anti-cd30 antibodies |
BRPI0618133A2 (en) * | 2005-11-01 | 2011-08-16 | Wyeth Corp | sodium chloride solution for drug reconstitution or dilution |
US8048848B2 (en) | 2006-02-03 | 2011-11-01 | Prolor Biotech Ltd. | Long-acting interferons and derivatives thereof and methods thereof |
PL2631242T3 (en) | 2006-04-04 | 2023-03-20 | Takeda Pharmaceutical Company Limited | A process for concentration of a polypeptide |
EP2423305A1 (en) | 2006-06-19 | 2012-02-29 | Catalyst Biosciences, Inc. | Modified coagulation factor IX polypeptides and use thereof for treatment |
US8015841B2 (en) | 2006-09-08 | 2011-09-13 | Praxair Technology, Inc. | Cryogenic refrigeration system for lyophilization |
US7700734B2 (en) | 2007-01-09 | 2010-04-20 | Shu-Wha Lin | Recombinant human factor IX and use thereof |
PL2369005T3 (en) | 2007-06-21 | 2013-10-31 | Univ Muenchen Tech | Biological active proteins having increased in vivo and/or in vitro stability |
WO2009051717A2 (en) | 2007-10-15 | 2009-04-23 | The University Of North Carolina At Chapel Hill | Human factor ix variants with an extended half life |
CN101952422A (en) | 2007-12-27 | 2011-01-19 | 巴克斯特国际公司 | The factors IX of chemically modified |
AU2009244633A1 (en) | 2008-04-16 | 2009-11-12 | Bayer Healthcare Llc | Modified Factor IX polypeptides and uses thereof |
WO2009140015A2 (en) | 2008-04-16 | 2009-11-19 | Bayer Healthcare Llc | Site-directed modification of factor ix |
CN102105582A (en) | 2008-04-21 | 2011-06-22 | 诺沃-诺迪斯克有限公司 | Hyperglycosylated human coagulation factor IX |
ES2755029T3 (en) | 2008-08-05 | 2020-04-21 | Wyeth Llc | Freeze-drying above collapse temperature |
US20110236412A1 (en) | 2008-09-24 | 2011-09-29 | Stabilitech Ltd. | Method for Preserving Polypeptides Using a Sugar and Polyethyleneimine |
CN102695499A (en) | 2009-06-18 | 2012-09-26 | 惠氏有限责任公司 | Lyophilized formulations for small modular immunopharmaceuticals |
WO2011017070A1 (en) * | 2009-07-28 | 2011-02-10 | Merck Sharp & Dohme Corp. | Methods for producing high concentration lyophilized pharmaceutical formulations |
KR20180118808A (en) | 2010-07-09 | 2018-10-31 | 바이오버라티브 테라퓨틱스 인크. | Factor ix polypeptides and methods of use thereof |
SI2623497T1 (en) | 2010-09-30 | 2016-04-29 | Toyama Chemical Co., Ltd. | Meglumine salt of 6-fluoro-3-hydroxy-2-pyrazine carboxamide |
SG192671A1 (en) | 2011-02-09 | 2013-09-30 | Glaxosmithkline Llc | Lyophilized formulations |
WO2013185113A1 (en) | 2012-06-08 | 2013-12-12 | Biogen Idec Ma Inc. | Procoagulant compounds |
TWI750197B (en) * | 2012-09-25 | 2021-12-21 | 美商百歐維拉提夫治療公司 | Methods of using fix polypeptides |
EP2968498A4 (en) * | 2013-03-15 | 2016-09-07 | Biogen Ma Inc | Factor ix polypeptide formulations |
EA038573B1 (en) * | 2014-03-24 | 2021-09-16 | Биовератив Терапьютикс Инк. | Lyophilized factor ix formulation for preventing bleeding episodes |
-
2015
- 2015-03-24 EA EA201691807A patent/EA038573B1/en unknown
- 2015-03-24 EP EP15769411.8A patent/EP3123090A4/en active Pending
- 2015-03-24 SG SG10201808249VA patent/SG10201808249VA/en unknown
- 2015-03-24 AU AU2015236340A patent/AU2015236340B2/en not_active Withdrawn - After Issue
- 2015-03-24 WO PCT/US2015/022141 patent/WO2015148444A1/en active Application Filing
- 2015-03-24 CA CA2943034A patent/CA2943034C/en active Active
- 2015-03-24 US US15/128,951 patent/US10772942B2/en active Active
- 2015-03-24 TW TW104109389A patent/TWI700101B/en active
- 2015-03-24 MA MA039779A patent/MA39779A/en unknown
- 2015-03-24 JP JP2016558751A patent/JP7058940B2/en active Active
- 2015-03-24 EA EA202092926A patent/EA202092926A3/en unknown
- 2015-03-24 SG SG10201913735SA patent/SG10201913735SA/en unknown
- 2015-03-24 MX MX2016012447A patent/MX2016012447A/en unknown
- 2015-03-24 KR KR1020167028692A patent/KR102385372B1/en active IP Right Grant
- 2015-03-24 SG SG11201607642RA patent/SG11201607642RA/en unknown
- 2015-03-25 AR ARP150100880A patent/AR099838A1/en unknown
-
2016
- 2016-09-18 IL IL247869A patent/IL247869B/en active IP Right Grant
- 2016-09-22 CL CL2016002386A patent/CL2016002386A1/en unknown
- 2016-09-23 PH PH12016501877A patent/PH12016501877A1/en unknown
- 2016-09-23 MX MX2021012939A patent/MX2021012939A/en unknown
-
2020
- 2020-01-26 IL IL272257A patent/IL272257B/en active IP Right Grant
- 2020-02-03 JP JP2020016131A patent/JP2020063313A/en active Pending
- 2020-04-30 AU AU2020202863A patent/AU2020202863B2/en active Active
- 2020-08-17 US US16/995,173 patent/US20210069307A1/en active Pending
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2021
- 2021-03-02 IL IL281197A patent/IL281197B/en unknown
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2022
- 2022-01-20 JP JP2022007013A patent/JP7503583B2/en active Active
- 2022-08-10 AU AU2022215218A patent/AU2022215218A1/en active Pending
-
2024
- 2024-03-06 JP JP2024033771A patent/JP2024053015A/en active Pending
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