PL2503995T3 - Sposoby liofilizacji, kompozycje i zestawy - Google Patents

Sposoby liofilizacji, kompozycje i zestawy

Info

Publication number
PL2503995T3
PL2503995T3 PL10833862T PL10833862T PL2503995T3 PL 2503995 T3 PL2503995 T3 PL 2503995T3 PL 10833862 T PL10833862 T PL 10833862T PL 10833862 T PL10833862 T PL 10833862T PL 2503995 T3 PL2503995 T3 PL 2503995T3
Authority
PL
Poland
Prior art keywords
kits
compositions
lyophilization methods
lyophilization
methods
Prior art date
Application number
PL10833862T
Other languages
English (en)
Inventor
Jianxin Guo
Anthony Klos
Deborah Barnette
Original Assignee
Grifols Therapeutics Inc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=44067198&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=PL2503995(T3) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Grifols Therapeutics Inc filed Critical Grifols Therapeutics Inc
Publication of PL2503995T3 publication Critical patent/PL2503995T3/pl

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/19Particulate 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P7/00Drugs for disorders of the blood or the extracellular fluid
    • A61P7/02Antithrombotic agents; Anticoagulants; Platelet aggregation inhibitors

Landscapes

  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Public Health (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Veterinary Medicine (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Organic Chemistry (AREA)
  • Hematology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Diabetes (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Medicinal Preparation (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Drying Of Solid Materials (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
PL10833862T 2009-11-24 2010-11-23 Sposoby liofilizacji, kompozycje i zestawy PL2503995T3 (pl)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US26401409P 2009-11-24 2009-11-24
EP10833862.5A EP2503995B1 (en) 2009-11-24 2010-11-23 Lyophilization methods, compositions, and kits
PCT/US2010/057816 WO2011066291A2 (en) 2009-11-24 2010-11-23 Lyophilization methods, compositions, and kits

Publications (1)

Publication Number Publication Date
PL2503995T3 true PL2503995T3 (pl) 2018-01-31

Family

ID=44067198

Family Applications (1)

Application Number Title Priority Date Filing Date
PL10833862T PL2503995T3 (pl) 2009-11-24 2010-11-23 Sposoby liofilizacji, kompozycje i zestawy

Country Status (19)

Country Link
US (1) US8648177B2 (pl)
EP (1) EP2503995B1 (pl)
JP (2) JP5810091B2 (pl)
KR (1) KR101567901B1 (pl)
CN (1) CN102762196B (pl)
AU (1) AU2010324839B2 (pl)
BR (1) BR112012012460B1 (pl)
CA (1) CA2781120C (pl)
CL (1) CL2012001350A1 (pl)
ES (1) ES2648249T3 (pl)
HU (1) HUE037733T2 (pl)
IL (1) IL219827A (pl)
MX (1) MX2012005782A (pl)
NZ (1) NZ600271A (pl)
PL (1) PL2503995T3 (pl)
PT (1) PT2503995T (pl)
RU (1) RU2540480C2 (pl)
WO (1) WO2011066291A2 (pl)
ZA (1) ZA201203603B (pl)

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EP2496246B1 (en) 2009-11-03 2018-06-27 Grifols Therapeutics LLC Composition, method, and kit for alpha-1 proteinase inhibitor
PL2503995T3 (pl) * 2009-11-24 2018-01-31 Grifols Therapeutics Inc Sposoby liofilizacji, kompozycje i zestawy
WO2011140519A2 (en) 2010-05-07 2011-11-10 Medicus Biosciences, Llc In vivo gelling pharmaceutical pre-formulation
US11083821B2 (en) 2011-08-10 2021-08-10 C.P. Medical Corporation Biocompatible hydrogel polymer formulations for the controlled delivery of biomolecules
US10111985B2 (en) 2011-08-10 2018-10-30 Medicus Biosciences, Llc Biocompatible hydrogel polymer formulations for the controlled delivery of biomolecules
JP6206987B2 (ja) 2012-05-11 2017-10-04 メディカス バイオサイエンシーズ,エルエルシー 網膜剥離の処置のための生体適合性ヒドロゲル製剤
HUE041381T2 (hu) 2012-08-16 2019-05-28 Pfizer Glikokonjugációs eljárások és kompozíciók
US20140199286A1 (en) * 2013-01-15 2014-07-17 Teva Pharmaceutical Industries, Ltd. Lyophilization process
US20140271767A1 (en) * 2013-03-14 2014-09-18 Medicus Biosciences Llc Biocompatible hydrogel polymer matrix for delivery of cells
WO2014204203A1 (ko) 2013-06-18 2014-12-24 엘지전자 주식회사 무선 자원의 용도 변경을 지원하는 무선 통신 시스템에서 전력 제어 방법 및 이를 위한 장치
EP3065756B1 (en) 2013-11-07 2019-02-20 Dr. August Wolff GmbH & Co. KG Arzneimittel Storage stable lyophilized tripeptide formulations
KR102021605B1 (ko) * 2015-02-13 2019-09-16 주식회사 씨젠 다중타겟 핵산서열 증폭반응용 조성물의 동결건조 방법
CN104856965B (zh) * 2015-05-29 2018-07-20 湖南科伦制药有限公司 一种注射用胸腺肽的冻干方法
JP7020913B2 (ja) 2015-09-07 2022-02-16 持田製薬株式会社 アルギン酸凍結乾燥製剤
TW201715185A (zh) * 2015-10-29 2017-05-01 Tai Yiaeh Enterprise Co Ltd 冷凍過程的即時檢測方法
CN107467013A (zh) * 2017-09-20 2017-12-15 上海贞元诊断用品科技有限公司 一种可长期保存的质控品通用血浆基质制备方法
CN107677528A (zh) * 2017-09-20 2018-02-09 上海贞元诊断用品科技有限公司 一种肝素抗凝检测试剂的校准品及质控品及其制备方法
US10793327B2 (en) 2017-10-09 2020-10-06 Terumo Bct Biotechnologies, Llc Lyophilization container and method of using same
EP3938742A1 (en) 2019-03-14 2022-01-19 Terumo BCT Biotechnologies, LLC Multi-part lyophilization container and method of use

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JPS597693B2 (ja) * 1978-01-07 1984-02-20 株式会社ミドリ十字 抗トロンビン製剤及びその製法
US4337242A (en) 1980-02-05 1982-06-29 Merck & Co., Inc. Vaccine stabilizer containing L-glutamic acid and L-arginine
DE3262575D1 (en) 1981-12-23 1985-04-18 Schering Corp Stabilised interferon formulations and their preparation
US4517294A (en) 1982-03-03 1985-05-14 Genentech, Inc. Human antithrombin III
US4632981A (en) 1982-07-30 1986-12-30 Genentech, Inc. Human antithrombin III
US5218091A (en) 1982-08-13 1993-06-08 Zymogenetics, Inc. Glycolytic promoters for regulated protein expression: protease inhibitor
US4711848A (en) 1984-03-14 1987-12-08 Zymogenetics, Inc. Site specific mutagenesis in alpha-1-antitrypsin
US4931373A (en) 1984-05-25 1990-06-05 Zymogenetics, Inc. Stable DNA constructs for expression of α-1 antitrypsin
US4732973A (en) 1984-06-14 1988-03-22 Chiron Corporation Active site modified protease α-1-antitrypsin inhibitors
WO1986000337A1 (fr) 1984-06-19 1986-01-16 Transgene S.A. DERIVES DE L'alpha1-ANTITRYPSINE HUMAINE ET PROCEDE POUR LEUR PREPARATION
US5366894A (en) 1986-06-30 1994-11-22 Pharmaceutical Proteins Limited Peptide production
US4873316A (en) 1987-06-23 1989-10-10 Biogen, Inc. Isolation of exogenous recombinant proteins from the milk of transgenic mammals
DE3901917A1 (de) 1989-01-24 1990-07-26 Behringwerke Ag Mutanten von humanem antithrombin iii
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US5079336A (en) 1989-06-23 1992-01-07 The Trustees Of The University Of Pennsylvania α-1-antichymotrypsin, analogues and methods of production
US5032405A (en) 1989-09-27 1991-07-16 Warner-Lambert Company Oral pharmaceutical composition for acid sensitive proteinaceous agents
US5134119A (en) 1990-10-16 1992-07-28 Lezdey John Treatment of inflammation using 358 substituted alpha-antitrypsin
JP3479539B2 (ja) 1992-04-10 2003-12-15 エーザイ株式会社 ヒトアンチトロンビンiii変異体
US5561115A (en) 1994-08-10 1996-10-01 Bayer Corporation Low temperature albumin fractionation using sodium caprylate as a partitioning agent
US5843705A (en) 1995-02-21 1998-12-01 Genzyme Transgenic Corporation Transgenically produced antithrombin III
AT405905B (de) * 1997-03-25 1999-12-27 Immuno Ag Neue verwendung von antithrombin iii
AT407114B (de) 1997-06-10 2000-12-27 Immuno Ag Alpha 1-antitrypsin-präparation sowie verfahren zu deren herstellung
CA2328397A1 (en) 1998-05-12 1999-11-18 Temple University - Of The Commonwealth System Of Higher Education Human antithrombin iiis and methods related thereto
DE60035260T2 (de) * 1999-02-22 2007-10-18 The University Of Connecticut, Farmington Neue albuminfreie faktor viii formulierungen
US20040157911A1 (en) 1999-08-31 2004-08-12 Spiridon Spireas Storage-stable and bio-stable formulations of ace inhibitors, and methods for preparation thereof
WO2002002793A1 (fr) 2000-07-05 2002-01-10 Japan As Represented By Secretary Of Osaka University Processus de production de glycoproteine
US6432658B1 (en) * 2000-09-13 2002-08-13 Affinity Biologicals, Inc. Method for measuring antithrombin activity
AU2002335046A1 (en) 2001-10-19 2003-05-06 Inhale Therapeutic Systems, Inc. The use of proton sequestering agents in drug formulations
AU2003223497A1 (en) 2002-04-05 2003-10-27 Centocor, Inc. Asthma-related anti-il-13 immunoglobulin derived proteins, compositions, methods and uses
WO2003090682A2 (en) 2002-04-25 2003-11-06 The Scripps Research Institute Treatment and prevention of pulmonary conditions
DK1664123T4 (da) 2003-09-22 2012-03-05 Kamada Ltd Storskalafremstilling af alfa-1-proteinaseinhibitor og anvendelse deraf
US7691810B2 (en) 2003-10-09 2010-04-06 Kyowa Hakko Kirin Co., Ltd Method of producing recombinant antithrombin III composition
CA2545855A1 (en) 2003-11-14 2005-06-02 Baxter International Inc. Alpha 1-antitrypsin compositions and treatment methods using such compositions
CA2554018A1 (en) * 2004-03-04 2005-09-29 Wyeth Lyophilization method to improve excipient crystallization
KR20080071192A (ko) * 2005-11-22 2008-08-01 와이어쓰 면역글로불린 융합 단백질 제형
CA2641872A1 (en) 2006-02-09 2007-08-16 Kamada Ltd. Alpha-i antitrypsin for treating exacerbation episodes of pulmonary diseases
CA2665902A1 (en) * 2006-10-03 2008-04-10 Wyeth Lyophilization methods and apparatuses
PL2503995T3 (pl) * 2009-11-24 2018-01-31 Grifols Therapeutics Inc Sposoby liofilizacji, kompozycje i zestawy

Also Published As

Publication number Publication date
CA2781120C (en) 2015-01-27
US8648177B2 (en) 2014-02-11
EP2503995A2 (en) 2012-10-03
BR112012012460A8 (pt) 2018-07-03
CA2781120A1 (en) 2011-06-03
PT2503995T (pt) 2017-11-23
CN102762196A (zh) 2012-10-31
US20130040890A1 (en) 2013-02-14
WO2011066291A3 (en) 2011-10-06
BR112012012460A2 (pt) 2017-10-10
RU2012126125A (ru) 2013-12-27
JP2013512194A (ja) 2013-04-11
ZA201203603B (en) 2016-01-27
KR20120102715A (ko) 2012-09-18
AU2010324839A1 (en) 2012-06-14
CL2012001350A1 (es) 2012-09-28
EP2503995A4 (en) 2014-05-21
AU2010324839B2 (en) 2015-02-19
EP2503995B1 (en) 2017-11-01
WO2011066291A2 (en) 2011-06-03
IL219827A0 (en) 2012-07-31
CN102762196B (zh) 2014-05-14
WO2011066291A4 (en) 2011-12-22
BR112012012460B1 (pt) 2020-06-23
JP5810091B2 (ja) 2015-11-11
NZ600271A (en) 2013-09-27
ES2648249T3 (es) 2017-12-29
IL219827A (en) 2016-12-29
MX2012005782A (es) 2012-08-03
JP2015155455A (ja) 2015-08-27
RU2540480C2 (ru) 2015-02-10
HUE037733T2 (hu) 2018-09-28
KR101567901B1 (ko) 2015-11-10

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