DK2672986T3 - Frysetørrede formuleringer - Google Patents

Frysetørrede formuleringer Download PDF

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Publication number
DK2672986T3
DK2672986T3 DK12744782.9T DK12744782T DK2672986T3 DK 2672986 T3 DK2672986 T3 DK 2672986T3 DK 12744782 T DK12744782 T DK 12744782T DK 2672986 T3 DK2672986 T3 DK 2672986T3
Authority
DK
Denmark
Prior art keywords
dried formulations
frozen dried
frozen
formulations
dried
Prior art date
Application number
DK12744782.9T
Other languages
English (en)
Inventor
James Kranz
Joseph Rinella
Original Assignee
Glaxosmithkline Llc
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
Application filed by Glaxosmithkline Llc filed Critical Glaxosmithkline Llc
Application granted granted Critical
Publication of DK2672986T3 publication Critical patent/DK2672986T3/da

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K39/395Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • A61K39/39591Stabilisation, fragmentation
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K1/00General methods for the preparation of peptides, i.e. processes for the organic chemical preparation of peptides or proteins of any length
    • C07K1/02General methods for the preparation of peptides, i.e. processes for the organic chemical preparation of peptides or proteins of any length in solution
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00Medicinal preparations containing peptides
    • A61K38/16Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00Medicinal preparations containing peptides
    • A61K38/16Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/22Hormones
    • A61K38/26Glucagons
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00Drugs for disorders of the metabolism
    • A61P3/08Drugs for disorders of the metabolism for glucose homeostasis
    • A61P3/10Drugs for disorders of the metabolism for glucose homeostasis for hyperglycaemia, e.g. antidiabetics
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K16/00Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/18Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/22Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against growth factors ; against growth regulators
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K16/00Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/18Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/24Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against cytokines, lymphokines or interferons
    • C07K16/244Interleukins [IL]
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K16/00Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/18Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/28Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/2878Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against the NGF-receptor/TNF-receptor superfamily, e.g. CD27, CD30, CD40, CD95
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K16/00Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/18Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/28Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/2887Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against CD20
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/50Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/56Immunoglobulins specific features characterized by immunoglobulin fragments variable (Fv) region, i.e. VH and/or VL
    • C07K2317/569Single domain, e.g. dAb, sdAb, VHH, VNAR or nanobody®

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Immunology (AREA)
  • Organic Chemistry (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Molecular Biology (AREA)
  • Genetics & Genomics (AREA)
  • Biophysics (AREA)
  • Biochemistry (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Epidemiology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Endocrinology (AREA)
  • Mycology (AREA)
  • Microbiology (AREA)
  • Zoology (AREA)
  • Diabetes (AREA)
  • Hematology (AREA)
  • Obesity (AREA)
  • Emergency Medicine (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Analytical Chemistry (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Peptides Or Proteins (AREA)
  • Medicinal Preparation (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
DK12744782.9T 2011-02-09 2012-02-09 Frysetørrede formuleringer DK2672986T3 (da)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US201161440918P 2011-02-09 2011-02-09
PCT/US2012/024452 WO2012109429A2 (en) 2011-02-09 2012-02-09 Lyophilized formulations

Publications (1)

Publication Number Publication Date
DK2672986T3 true DK2672986T3 (da) 2020-06-08

Family

ID=46639199

Family Applications (1)

Application Number Title Priority Date Filing Date
DK12744782.9T DK2672986T3 (da) 2011-02-09 2012-02-09 Frysetørrede formuleringer

Country Status (16)

Country Link
US (1) US10286037B2 (da)
EP (1) EP2672986B1 (da)
JP (1) JP6125436B2 (da)
KR (1) KR20140044305A (da)
CN (2) CN107837395A (da)
AU (1) AU2012214419B2 (da)
BR (1) BR112013020383A2 (da)
CA (1) CA2827033A1 (da)
DK (1) DK2672986T3 (da)
EA (1) EA029972B1 (da)
ES (1) ES2791690T3 (da)
IL (1) IL227896B (da)
MX (1) MX2013009280A (da)
SG (1) SG192671A1 (da)
WO (1) WO2012109429A2 (da)
ZA (1) ZA201306118B (da)

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WO2009120927A2 (en) 2008-03-28 2009-10-01 Smithkline Beecham Corporation Methods of treatment
EA038573B1 (ru) 2014-03-24 2021-09-16 Биовератив Терапьютикс Инк. Лиофилизированный состав, содержащий фактор ix, для предупреждения приступов кровотечения
CN103920148B (zh) * 2014-04-24 2016-06-22 山东新华医疗器械股份有限公司 一种单克隆抗体制剂的冷冻干燥工艺
CN103966323A (zh) * 2014-04-25 2014-08-06 广州迪澳生物科技有限公司 可常温运输的干粉化恒温扩增检测试剂及其制备方法
WO2015171810A1 (en) * 2014-05-06 2015-11-12 The Regents Of The University Of Colorado, A Body Corporate Compositions, methods and uses for thermally stable human papillomavirus formulations
US11273127B2 (en) * 2014-05-06 2022-03-15 The Regents Of The University Of Colorado, A Body Corporate Compositions, methods and uses for thermally stable multi-targeted antigens
US20180021409A1 (en) * 2014-06-25 2018-01-25 Glaxosmithkline Llc Pharmaceutical Composition
AR105616A1 (es) 2015-05-07 2017-10-25 Lilly Co Eli Proteínas de fusión
EP3313420B1 (en) 2015-06-25 2024-03-13 The Children's Medical Center Corporation Methods and compositions relating to hematopoietic stem cell expansion, enrichment, and maintenance
TWI750133B (zh) 2015-08-24 2021-12-21 美商葛蘭素史密斯克萊有限責任公司 生藥組成物
EP4049665A1 (en) 2016-03-15 2022-08-31 Children's Medical Center Corporation Methods and compositions relating to hematopoietic stem cell expansion
CN107661288A (zh) * 2016-07-29 2018-02-06 江苏泰康生物医药有限公司 含有glp‑1 类似物融合蛋白的稳定液体制剂及其制备
CA3047059A1 (en) * 2016-12-19 2018-06-28 Glenmark Pharmaceuticals S.A. Novel tnfr agonists and uses thereof
MX2019007433A (es) * 2016-12-22 2019-08-16 Genentech Inc Metodos y formulaciones para reducir el tiempo de reconstitucion de los polipeptidos liofilizados.
EP3634467A4 (en) 2017-06-06 2021-07-28 GlaxoSmithKline LLC BIOPHARMACEUTICAL COMPOSITIONS AND PROCEDURES FOR PEDIATRIC PATIENTS
CN110747263B (zh) * 2019-11-12 2023-04-07 南京黎明生物制品有限公司 一种冻干添加剂及荧光pcr反应混合物干粉和制备方法
CN111165656A (zh) * 2020-01-09 2020-05-19 南京大学(溧水)生态环境研究院 一种黑水虻冻干粉高效制备方法
CN113081955B (zh) * 2020-01-09 2023-10-24 鲁南制药集团股份有限公司 一种免疫抑制剂单克隆抗体的制剂
CN116643056A (zh) * 2022-02-15 2023-08-25 厦门万泰凯瑞生物技术有限公司 促甲状腺激素受体复合物、试剂盒、制备方法和用途
WO2023225534A1 (en) 2022-05-18 2023-11-23 Protomer Technologies Inc. Aromatic boron-containing compounds and related insulin analogs
CN116159027A (zh) * 2022-12-29 2023-05-26 江苏诺泰澳赛诺生物制药股份有限公司 一种司美格鲁肽冻干药物组合物及其制备方法

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GB9803448D0 (en) 1998-02-18 1998-04-15 Pharma Mar Sa Pharmaceutical formulation
US20030017169A1 (en) * 2000-12-29 2003-01-23 Sidney Pestka Controlled release systems for polymers
EP2277910A1 (en) * 2001-12-21 2011-01-26 Human Genome Sciences, Inc. Albumin fusion proteins
US7582312B2 (en) * 2004-11-15 2009-09-01 Discovery Laboratories, Inc. Methods to produce lung surfactant formulations via lyophilization and formulations and uses thereof
US8436190B2 (en) * 2005-01-14 2013-05-07 Cephalon, Inc. Bendamustine pharmaceutical compositions
US8202837B2 (en) 2005-11-04 2012-06-19 Glaxosmithkline Llc Methods for administering hypoglycemic agents
RU2464973C2 (ru) 2006-01-24 2012-10-27 НексБио, Инк. Технология изготовления макромолекулярных микросфер
CN101558081B (zh) * 2006-12-11 2014-08-20 伯拉考成像股份公司 用于诊断和治疗应用的纤维蛋白结合肽缀合体
CN101274096B (zh) * 2007-03-29 2011-04-27 上海万兴生物制药有限公司 一种稳定的巴曲酶药物组合物
KR101478779B1 (ko) 2007-11-22 2015-01-05 에스케이케미칼주식회사 재수화시간이 향상된 택산 유도체 함유 동결건조 조성물 및이의 제조방법
US8275057B2 (en) * 2008-12-19 2012-09-25 Intel Corporation Methods and systems to estimate channel frequency response in multi-carrier signals
WO2011017070A1 (en) 2009-07-28 2011-02-10 Merck Sharp & Dohme Corp. Methods for producing high concentration lyophilized pharmaceutical formulations
CN102573459A (zh) 2009-08-04 2012-07-11 弗·哈夫曼-拉罗切有限公司 粘度降低的浓缩多肽制剂
CN102018676B (zh) * 2010-12-21 2012-12-05 中山大学 一种水溶性药物纳米粒及其混悬型气雾剂的制备方法

Also Published As

Publication number Publication date
CN107837395A (zh) 2018-03-27
JP6125436B2 (ja) 2017-05-10
EP2672986A2 (en) 2013-12-18
EA029972B1 (ru) 2018-06-29
EP2672986A4 (en) 2015-12-30
EP2672986B1 (en) 2020-03-18
CN103492407A (zh) 2014-01-01
IL227896B (en) 2018-12-31
EA201391136A1 (ru) 2014-05-30
BR112013020383A2 (pt) 2017-06-13
KR20140044305A (ko) 2014-04-14
SG192671A1 (en) 2013-09-30
AU2012214419B2 (en) 2015-12-24
IL227896A0 (en) 2013-09-30
WO2012109429A2 (en) 2012-08-16
CA2827033A1 (en) 2012-08-16
US20140044717A1 (en) 2014-02-13
JP2014506578A (ja) 2014-03-17
AU2012214419A1 (en) 2013-08-29
MX2013009280A (es) 2013-09-06
ES2791690T3 (es) 2020-11-05
ZA201306118B (en) 2014-04-30
US10286037B2 (en) 2019-05-14
WO2012109429A3 (en) 2012-10-18

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