JP2020183387A5 - - Google Patents

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Publication number
JP2020183387A5
JP2020183387A5 JP2020107507A JP2020107507A JP2020183387A5 JP 2020183387 A5 JP2020183387 A5 JP 2020183387A5 JP 2020107507 A JP2020107507 A JP 2020107507A JP 2020107507 A JP2020107507 A JP 2020107507A JP 2020183387 A5 JP2020183387 A5 JP 2020183387A5
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JP
Japan
Prior art keywords
preparation
preparation according
antibody concentration
aqueous pharmaceutical
concentration
Prior art date
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.)
Pending
Application number
JP2020107507A
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JP2020183387A (ja
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Publication date
Application filed filed Critical
Publication of JP2020183387A publication Critical patent/JP2020183387A/ja
Publication of JP2020183387A5 publication Critical patent/JP2020183387A5/ja
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Claims (21)

  1. （ａ）５０から２００ｍｇ／ｍＬの濃度であるアダリムマブ、及び
    （ｂ）水
    を含む水性医薬製剤であって、
    該製剤は緩衝系を含まず、皮下送達のため製剤化され及び、製剤のｐＨが４から８である、水性医薬製剤。
  2. （ａ）５０から２００ｍｇ／ｍＬの濃度であるアダリムマブ、及び
    （ｂ）水
    を含む水性医薬製剤であって、
    該製剤は、実質的に緩衝液を含まず、皮下送達のため製剤化され、製剤のｐＨが４から８である、水性医薬製剤。
  3. 抗体の濃度が５０ｍｇ／ｍＬである、請求項１又は２に記載の製剤。
  4. 抗体の濃度が少なくとも１００ｍｇ／ｍＬである、請求項１又は２に記載の製剤。
  5. 抗体の濃度が１００ｍｇ／ｍＬである、請求項１又は２に記載の製剤。
  6. 抗体の濃度が少なくとも１５０ｍｇ／ｍＬである、請求項１又は２に記載の製剤。
  7. 抗体の濃度が１５０ｍｇ／ｍＬである、請求項１又は２に記載の製剤。
  8. 抗体の濃度が２００ｍｇ／ｍＬである、請求項１又は２に記載の製剤。
  9. 製剤のｐＨが５から７である、請求項１又は２に記載の製剤。
  10. 製剤が、さらに非イオン性賦形剤を含む、請求項１又は２に記載の製剤。
  11. 製剤が、さらにポリオールを含む、請求項１又は２に記載の製剤。
  12. 製剤が、さらにマンニトールを含む、請求項１又は２に記載の製剤。
  13. 製剤が、さらにソルビトールを含む、請求項１又は２に記載の製剤。
  14. 製剤が、さらにトレハロースを含む、請求項１又は２に記載の製剤。
  15. 製剤が、さらにショ糖を含む、請求項１又は２に記載の製剤。
  16. 製剤が、さらに界面活性剤を含む、請求項１又は２に記載の製剤。
  17. 界面活性剤が、ポリソルベート２０である請求項１６に記載の製剤。
  18. 界面活性剤が、ポリソルベート８０である請求項１６に記載の製剤。
  19. 請求項１又は２に記載の製剤を含む装置。
  20. シリンジである、請求項１９に記載の装置。
  21. 注射用ペンである、請求項１９に記載の装置。
JP2020107507A 2007-11-30 2020-06-23 タンパク質製剤及びその製造方法 Pending JP2020183387A (ja)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US499207P 2007-11-30 2007-11-30
US61/004,992 2007-11-30

Related Parent Applications (1)

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JP2015112856A Division JP6752500B2 (ja) 2007-11-30 2015-06-03 タンパク質製剤及びその製造方法

Publications (2)

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JP2020183387A JP2020183387A (ja) 2020-11-12
JP2020183387A5 true JP2020183387A5 (ja) 2021-03-25

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Family Applications (6)

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JP2010536208A Active JP5840364B2 (ja) 2007-11-30 2008-11-28 タンパク質製剤及びその製造方法
JP2014075367A Pending JP2014159437A (ja) 2007-11-30 2014-04-01 タンパク質製剤及びその製造方法
JP2015112856A Active JP6752500B2 (ja) 2007-11-30 2015-06-03 タンパク質製剤及びその製造方法
JP2016107020A Pending JP2016185971A (ja) 2007-11-30 2016-05-30 タンパク質製剤及びその製造方法
JP2018008763A Pending JP2018080202A (ja) 2007-11-30 2018-01-23 タンパク質製剤及びその製造方法
JP2020107507A Pending JP2020183387A (ja) 2007-11-30 2020-06-23 タンパク質製剤及びその製造方法

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JP2010536208A Active JP5840364B2 (ja) 2007-11-30 2008-11-28 タンパク質製剤及びその製造方法
JP2014075367A Pending JP2014159437A (ja) 2007-11-30 2014-04-01 タンパク質製剤及びその製造方法
JP2015112856A Active JP6752500B2 (ja) 2007-11-30 2015-06-03 タンパク質製剤及びその製造方法
JP2016107020A Pending JP2016185971A (ja) 2007-11-30 2016-05-30 タンパク質製剤及びその製造方法
JP2018008763A Pending JP2018080202A (ja) 2007-11-30 2018-01-23 タンパク質製剤及びその製造方法

Country Status (16)

Country Link
US (1) US8420081B2 (ja)
EP (2) EP3189831A1 (ja)
JP (6) JP5840364B2 (ja)
KR (4) KR101868778B1 (ja)
CN (3) CN104645329A (ja)
AU (1) AU2008334099B2 (ja)
BR (1) BRPI0819714A8 (ja)
CA (2) CA2904458C (ja)
IL (4) IL206081A (ja)
MX (1) MX354100B (ja)
NZ (4) NZ585702A (ja)
RU (2) RU2473360C2 (ja)
SG (2) SG10201604258YA (ja)
TW (4) TWI629064B (ja)
WO (1) WO2009073569A2 (ja)
ZA (1) ZA201205433B (ja)

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