JP5357391B2 - 液状形態及び凍結乾燥形態の免疫グロブリンg組成物用安定化配合物 - Google Patents
液状形態及び凍結乾燥形態の免疫グロブリンg組成物用安定化配合物 Download PDFInfo
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- JP5357391B2 JP5357391B2 JP2006505786A JP2006505786A JP5357391B2 JP 5357391 B2 JP5357391 B2 JP 5357391B2 JP 2006505786 A JP2006505786 A JP 2006505786A JP 2006505786 A JP2006505786 A JP 2006505786A JP 5357391 B2 JP5357391 B2 JP 5357391B2
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K39/00—Medicinal preparations containing antigens or antibodies
- A61K39/395—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K39/00—Medicinal preparations containing antigens or antibodies
- A61K39/395—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
- A61K39/39591—Stabilisation, fragmentation
Description
国際特許出願WO02/092632において本出願人によって開発された方法に従って得られた濃縮物を、IgG組成物として使用した。およそ50g/lのIgGを含むこの濃縮物を、pH値4.6〜4.8に調整し、そして熱不安定性の不純物を除去するために、56℃にて2時間、熱処理にかける。
0.25:1又は2の懸濁した粒子を含む透明溶液;
0.50:少し懸濁した微粒子を含む透明溶液;
0.75:0.50のときよりも多い少しの懸濁した粒子を含む透明溶液;
2.0:さらに多くの懸濁した粒子を含む、わずかに改変した(modified)視覚的な外観;
5.0:多数の懸濁したフィラメント又は粒子;
10.0:さらに大きな粒子及び凝集体、さらには凝固体。
(a)サイズ除外クロマトグラフィー(方法2.2.29)によって測定される二量体量の変動、
(b)抗−補体活性の変動(方法2.6.17)、及び
(c)B型肝炎ウイルスに対する特異抗体、抗HBsの力価の変動(方法2.7.1))
に含まれる方法を参照して測定される。
手法
180〜200gの成体、雄、Sprangue−Dawly(IFFA-Credo:フランス)ラットを、60mg/kgの割合でペントバルビタール(Sanofi-France)を腹腔内注射によって麻酔する。麻酔されたラットを、37℃に自動温度調節されたマットレス上に仰向けに寝かせる。古典的な圧センサー及び動脈圧を継続的に計測することを可能にするレコーダーと接続されたカテーテルを、頸動脈に導入する。気管カニューレは、呼吸路を自由にすることを可能にする。IgG(溶液K及びT)の静脈内投与は、2.66ml/120分の速度で、動物の頸静脈内に導入されたカテーテルを通して行われる。
−生理学的血清を受ける1つのコントロール群、
−0.65 g/kgの割合にて溶液Tを受ける1つの処置群、及び
−0.65 g/kgの割合にて溶液Kを受ける1つの処置群。
手法
クエン酸三ナトリウム0.2M(1/9,v/v)の抗凝固溶液の存在下で、群0+のヒト赤血球を、pH7.4の通常濃度のPBSの生理食塩水溶液で3回洗浄する。様々な賦形剤中のタンパク質の水溶液を調製し、溶液Jを、NaCl 0.15M及びpH7に調整する。タンパク質及び賦形剤、ならびにそれらの各濃度は、表11に示される。各タンパク質溶液の4.5mlの試料を取り、10mlの目盛りのついたガラス管に入れる。その後、0.5mlの洗浄された赤血球を、各溶液に添加する。得られた混合物を、密閉した管を3〜4回上下に回転する事によって均質化する。均質化の終わりに、管を、カウンターディスプレー上に置き、沈降速度を表す、透明なメニスカス(meniscus)までの赤血球細胞のタンジェント(tangent)の明瞭なデカンテーションライン(decantation line)が出現するために要する時間を計測する。室温での実験結果は、表11に示される。
−血漿混合物の上清容量は、試験された混合物中で最も高く、従って、対応する最も低い粘度を示す;
−アルブミン混合物及び本発明の溶液Jは、同様の沈降速度(同容量の上清)を示す;
−従来技術のIgG混合物(すなわち、スクロース及びNaClを含む)は、最も少ない上清容量を導き、本発明の混合物J中においてよりも、赤血球の沈降が遅いことを意味し、さらに、上記の他の試験混合物と同様、上清は分離した溶血によって、バラ色に着色されていることを意味する。
Claims (9)
- ポリクローナル免疫グロブリンG組成物用安定化配合物であって、該配合物が、液状形態及び凍結乾燥形態の免疫グロブリンG組成物の安定化に適するように、30g/l〜50g/lの濃度のマンニトール、7g/l〜10g/lの濃度のグリシン、及び20〜50ppmの濃度の非イオン洗浄剤からなることを特徴とする安定化配合物。
- 安定化剤として、請求項1に記載の安定化配合物を含む、液状形態のポリクローナル免疫グロブリンG組成物。
- ポリクローナル免疫グロブリンG組成物及び請求項1に記載の安定化配合物の凍結乾燥によって得られる、凍結乾燥形態のポリクローナル免疫グロブリンG組成物。
- 室温にて6ヶ月の保存期間の後に、0.3%未満のポリマー量を含有することを特徴とする、請求項2に記載のポリクローナル免疫グロブリンG組成物。
- 室温にて12ヶ月又は40℃にて6ヶ月の保存期間の後に、0.3%未満のポリマー量を含有することを特徴とする、請求項3に記載のポリクローナル免疫グロブリンG組成物。
- 4℃にて24ヶ月の保存期間の後に、7%未満の二量体の量を含む組成物であることを特徴とする、請求項2〜4のいずれか1項に記載のポリクローナル免疫グロブリンG組成物。
- ヒト血漿の分画によって直接得られた液状形態のポリクローナル免疫グロブリンG組成物用の安定化剤としての、請求項1に記載の安定化配合物の使用。
- 凍結乾燥形態のポリクローナル免疫グロブリンG組成物の安定化のための、請求項1に記載の安定化配合物の使用。
- 凍結乾燥形態のポリクローナル免疫グロブリンG組成物を好適な水性媒体中において再構成した後に得られた、液状形態のポリクローナル免疫グロブリンG組成物の安定化のための、請求項1に記載の安定化配合物の使用。
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
FR03/04388 | 2003-04-09 | ||
FR0304388A FR2853551B1 (fr) | 2003-04-09 | 2003-04-09 | Formulation stabilisante pour compositions d'immunoglobulines g sous forme liquide et sous forme lyophilisee |
PCT/FR2004/000871 WO2004091656A2 (fr) | 2003-04-09 | 2004-04-08 | Formulation stabilisante pour compositions d'immunoglobulines G sous forme liquide et sous forme lyophilisEe |
Related Child Applications (1)
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JP2011110632A Division JP2011184454A (ja) | 2003-04-09 | 2011-05-17 | 液状形態及び凍結乾燥形態の免疫グロブリンg組成物用安定化配合物 |
Publications (3)
Publication Number | Publication Date |
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JP2006522780A JP2006522780A (ja) | 2006-10-05 |
JP2006522780A5 JP2006522780A5 (ja) | 2007-05-17 |
JP5357391B2 true JP5357391B2 (ja) | 2013-12-04 |
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JP2006505786A Expired - Fee Related JP5357391B2 (ja) | 2003-04-09 | 2004-04-08 | 液状形態及び凍結乾燥形態の免疫グロブリンg組成物用安定化配合物 |
JP2011110632A Withdrawn JP2011184454A (ja) | 2003-04-09 | 2011-05-17 | 液状形態及び凍結乾燥形態の免疫グロブリンg組成物用安定化配合物 |
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JP2011110632A Withdrawn JP2011184454A (ja) | 2003-04-09 | 2011-05-17 | 液状形態及び凍結乾燥形態の免疫グロブリンg組成物用安定化配合物 |
Country Status (12)
Country | Link |
---|---|
US (2) | US8388954B2 (ja) |
EP (1) | EP1610819B1 (ja) |
JP (2) | JP5357391B2 (ja) |
AU (1) | AU2004229205B2 (ja) |
BR (1) | BRPI0409249A (ja) |
CA (1) | CA2521909C (ja) |
DK (1) | DK1610819T3 (ja) |
ES (1) | ES2424992T3 (ja) |
FR (1) | FR2853551B1 (ja) |
IL (1) | IL171123A (ja) |
PL (1) | PL1610819T3 (ja) |
WO (1) | WO2004091656A2 (ja) |
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US6436704B1 (en) | 2000-04-10 | 2002-08-20 | Raven Biotechnologies, Inc. | Human pancreatic epithelial progenitor cells and methods of isolation and use thereof |
US8632778B2 (en) * | 2000-08-11 | 2014-01-21 | Chugai Seiyaku Kabushiki Kaisha | Stabilized anti-interleukin-6 antibody-containing preparations |
FR2824568B1 (fr) | 2001-05-11 | 2004-04-09 | Lab Francais Du Fractionnement | Procede de preparation de concentres d'immunoglobulines humaines a usage therapeutique |
WO2003009817A2 (en) * | 2001-07-25 | 2003-02-06 | Protein Design Labs, Inc. | Stable lyophilized pharmaceutical formulation of igg antibodies |
US20060246060A1 (en) * | 2002-07-02 | 2006-11-02 | Nesta Douglas P | Novel stable formulation |
FR2853551B1 (fr) * | 2003-04-09 | 2006-08-04 | Lab Francais Du Fractionnement | Formulation stabilisante pour compositions d'immunoglobulines g sous forme liquide et sous forme lyophilisee |
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2003
- 2003-04-09 FR FR0304388A patent/FR2853551B1/fr not_active Expired - Lifetime
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2004
- 2004-04-08 CA CA2521909A patent/CA2521909C/fr not_active Expired - Fee Related
- 2004-04-08 BR BRPI0409249-0A patent/BRPI0409249A/pt not_active Application Discontinuation
- 2004-04-08 JP JP2006505786A patent/JP5357391B2/ja not_active Expired - Fee Related
- 2004-04-08 WO PCT/FR2004/000871 patent/WO2004091656A2/fr active Application Filing
- 2004-04-08 ES ES04742459T patent/ES2424992T3/es not_active Expired - Lifetime
- 2004-04-08 EP EP04742459.3A patent/EP1610819B1/fr not_active Expired - Lifetime
- 2004-04-08 PL PL04742459T patent/PL1610819T3/pl unknown
- 2004-04-08 DK DK04742459.3T patent/DK1610819T3/da active
- 2004-04-08 US US10/552,314 patent/US8388954B2/en active Active
- 2004-04-08 AU AU2004229205A patent/AU2004229205B2/en not_active Ceased
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Also Published As
Publication number | Publication date |
---|---|
DK1610819T3 (da) | 2013-09-02 |
ES2424992T3 (es) | 2013-10-10 |
JP2006522780A (ja) | 2006-10-05 |
IL171123A (en) | 2010-02-17 |
FR2853551B1 (fr) | 2006-08-04 |
FR2853551A1 (fr) | 2004-10-15 |
CA2521909A1 (fr) | 2004-10-28 |
AU2004229205B2 (en) | 2008-11-13 |
WO2004091656A3 (fr) | 2005-01-27 |
US20070036779A1 (en) | 2007-02-15 |
US8388954B2 (en) | 2013-03-05 |
EP1610819B1 (fr) | 2013-06-19 |
EP1610819A2 (fr) | 2006-01-04 |
US20130202585A1 (en) | 2013-08-08 |
BRPI0409249A (pt) | 2006-04-18 |
AU2004229205A1 (en) | 2004-10-28 |
PL1610819T3 (pl) | 2013-10-31 |
US9463241B2 (en) | 2016-10-11 |
CA2521909C (fr) | 2012-11-06 |
WO2004091656A2 (fr) | 2004-10-28 |
JP2011184454A (ja) | 2011-09-22 |
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