JP2004536038A5 - - Google Patents

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Publication number
JP2004536038A5
JP2004536038A5 JP2002569171A JP2002569171A JP2004536038A5 JP 2004536038 A5 JP2004536038 A5 JP 2004536038A5 JP 2002569171 A JP2002569171 A JP 2002569171A JP 2002569171 A JP2002569171 A JP 2002569171A JP 2004536038 A5 JP2004536038 A5 JP 2004536038A5
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JP
Japan
Prior art keywords
aqueous solution
solution according
stimulating factor
colony stimulating
macrophage colony
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Legal status (The legal status 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 status listed.)
Withdrawn
Application number
JP2002569171A
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English (en)
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JP2004536038A (ja
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Publication date
Priority claimed from US09/800,016 external-priority patent/US20020141970A1/en
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Publication of JP2004536038A publication Critical patent/JP2004536038A/ja
Publication of JP2004536038A5 publication Critical patent/JP2004536038A5/ja
Withdrawn legal-status Critical Current

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Description

ヒトGM-CSFに感受性があり、そしてこのサイトカインを培養培地に添加すると、急速に増殖する細胞株TF-1(たとえば、Kitamura rt al.,J Cell Physiol 140:323-334(1989)を参照)を用いて、生物アッセイ(bioassay)を行った。生物活性を、GM-CSF(1ng/ml)の周知の量をH3-チミジン存在下の細胞に添加することにより評価した。GM-CSFに応答した細胞の増殖量が、細胞によりDNAに組み込まれたトリチウム化されたチミジン量を測定することにより定量化された。サラグラモスティムの切り取られた形状の生物アッセイの結果が示すことは、その形状が、Glnl１まで完全に切り取られた場合と同様、中間の位置(Arg4,Ser5,Ser7,Ser9及びThr10)まで切り取られた場合では、生物的活性の有意な変化が全く観察されなかった。

Claims (15)

  1. 組み換え型顆粒球マクロファージ・コロニー刺激因子及び0.0mM乃至50mMのEDTAを含む生理的に受け入れ可能な水溶液。
  2. 前記EDTAの濃度が0.1乃至5mMである請求項１記載の水溶液。
  3. 前記組み換え型顆粒球マクロファージ・コロニー刺激因子が、サラグラモスティム(sargramostim)である請求項１記載の水溶液。
  4. 前記EDTAの濃度が5mMであり、そしてさらに前記溶液がpH7.4を有し、そして10mMのTRIS-HCL、40mg/Mlのマニトール(mannitol)及び10mg/mlのサッカローズを含む請求項１乃至３のいずれか1項記載の水溶液。
  5. ベンジルアルコールをさらに含む請求項１乃至４のいずれか1項記載の水溶液。
  6. ベンジルアルコールが、1.1%の濃度である請求項５記載の水溶液。
  7. 500μg/mlの顆粒球マクロファージ・コロニー刺激因子、10mMのTRIS-HCl、40mg/mlのマニトール(mannitol)及び10mg/mlのサッカローズに濃度0.1乃至50mMにEDTAを混合することを含む、顆粒球マクロファージ・コロニー刺激因子の安定化した生理的に受け入れ可能な水溶液を調製するための方法。
  8. a) 請求項１乃至６の何れか1項記載の水溶液を調製する工程；そして
    b) 水溶液を凍結乾燥する工程を含む、
    組み替え型顆粒球マクロファージ・コロニー刺激因子を凍結乾燥した生成物を調製するための方法。
  9. 前記組み換え型顆粒球マクロファージ・コロニー刺激因子が、サラグラモスティム(sargramostim)である請求項７又は請求項８のいずれか１項記載の方法。
  10. 水溶液を凍結乾燥する工程をさらに含む請求項７乃至９のいずれか1項記載の方法。
  11. 請求項１乃至６のいずれか1項記載の水溶液を治療としての使用。
  12. 炎症性腸疾患の治療に請求項１乃至６の何れか1項記載の水溶液の使用。
  13. 炎症性腸疾患が、Crohn'疾患である請求項１２記載の使用。
  14. 潰瘍の治療に請求項1乃至６のいずれか1項記載の水溶液の使用。
  15. 生成物が、水和化されると請求項１乃至６のいずれか1項記載の生理的に受け付け可能な水溶液を生成する、組み換え型顆粒球マクロファージ・コロニー刺激因子の凍結乾燥された前記生成物。
JP2002569171A 2001-03-05 2002-03-04 顆粒球マクロファージ・コロニー刺激因子の安定性のある水溶液 Withdrawn JP2004536038A (ja)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US09/800,016 US20020141970A1 (en) 2001-03-05 2001-03-05 Stable aqueous solutions of granulocyte macrophage colony-stimulating factor
PCT/US2002/006428 WO2002069999A1 (en) 2001-03-05 2002-03-04 Stable aqueous solutions of granulocyte macrophage colony-stimulating factor

Related Child Applications (1)

Application Number Title Priority Date Filing Date
JP2009014633A Division JP2009161538A (ja) 2001-03-05 2009-01-26 顆粒球マクロファージ・コロニー刺激因子の安定性のある水溶液

Publications (2)

Publication Number Publication Date
JP2004536038A JP2004536038A (ja) 2004-12-02
JP2004536038A5 true JP2004536038A5 (ja) 2006-01-05

Family

ID=25177307

Family Applications (2)

Application Number Title Priority Date Filing Date
JP2002569171A Withdrawn JP2004536038A (ja) 2001-03-05 2002-03-04 顆粒球マクロファージ・コロニー刺激因子の安定性のある水溶液
JP2009014633A Pending JP2009161538A (ja) 2001-03-05 2009-01-26 顆粒球マクロファージ・コロニー刺激因子の安定性のある水溶液

Family Applications After (1)

Application Number Title Priority Date Filing Date
JP2009014633A Pending JP2009161538A (ja) 2001-03-05 2009-01-26 顆粒球マクロファージ・コロニー刺激因子の安定性のある水溶液

Country Status (10)

Country Link
US (3) US20020141970A1 (ja)
EP (1) EP1372700B1 (ja)
JP (2) JP2004536038A (ja)
AT (1) ATE362375T1 (ja)
CY (1) CY1107435T1 (ja)
DE (1) DE60220149T2 (ja)
DK (1) DK1372700T3 (ja)
ES (1) ES2287296T3 (ja)
PT (1) PT1372700E (ja)
WO (1) WO2002069999A1 (ja)

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WO2012136224A2 (en) * 2011-04-07 2012-10-11 Trifoilium Aps Methods and compositions for enhancing pulmonary host defense in acute and chronic radiation syndrome, therapeutic radiation intervention and cancer therapy
WO2015034920A2 (en) * 2013-09-03 2015-03-12 Sloan-Kettering Institute For Cancer Research Granulocyte macrophage colony-stimulating factor compositions
EP3171887A1 (en) * 2014-07-24 2017-05-31 Reponex Pharmaceuticals APS Compositions comprising granulocyte-macrophage colony-stimulating factor for the treatment of inflammatory bowel disease
WO2020002650A1 (en) * 2018-06-29 2020-01-02 Targovax Asa A formulation
BR112022018501A2 (pt) 2020-03-17 2022-10-25 Drugrecure Aps Formulação líquida de gm-csf para inalação

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