JP6010155B2 - 組み換え技術によって製造された第viii因子のための新規な保護組成物 - Google Patents
組み換え技術によって製造された第viii因子のための新規な保護組成物 Download PDFInfo
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- A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
- A61K47/183—Amino acids, e.g. glycine, EDTA or aspartame
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- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
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- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
- A61K47/42—Proteins; Polypeptides; Degradation products thereof; Derivatives thereof, e.g. albumin, gelatin or zein
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- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
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- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/08—Solutions
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Description
上記の実験の項の記載に従って、組み換え第VIII因子を調製した。この実験では、アルギニンとスクロースの組み合わせである凍結/凍結乾燥防止剤を有する製剤を、凍結/凍結乾燥防止剤としてスクロースまたはアルギニンのいずれかを有する製剤と比較する。塩化ナトリウムは、増量剤およびイオン強度プロバイダーとして機能する。
上記の実験の項の記載に従って、組み換え第VIII因子を調製した。この実験では、凍結/凍結乾燥防止剤としてスクロース、ならびに、増量剤およびイオン強度プロバイダーとしてアルギニンを有する製剤を調査する。凍結乾燥製剤中の第VIII因子の回収率について、初期濃度150 IU/mlで製剤を調査した。調査した組成を表IIIに示す。
上記の実験の項の記載に従って、組み換え第VIII因子を調製した。この実験では、界面活性剤としてポロキサマー(Poloxamer)188またはポリソルベート(Polysorbate)80を有する製剤を、界面活性剤を含まない製剤と比較する。凍結/凍結乾燥防止剤は、アルギニンとスクロースの組み合わせであり、塩化ナトリウムは、増量剤およびイオン強度プロバイダーとして使用する。表Vに示す製剤について、凍結乾燥工程にわたる第VIII因子の回収率を、第VIII因子の初期濃度150 IU/mlで調査した。
実施例3では、表面吸着によって起こる第VIII因の活性喪失を避けるための製剤において、界面活性剤が必要であることが示されたが、この実施例では、組み換えアルブミンがこの目的に使用し得るかどうかを調査する。
実施例3では、おそらく表面吸着によって起こる第VIII因子の活性喪失を避けるための製剤において、界面活性剤が必要であることが示され、実施例4では、溶液中のタンパク質の活性喪失を防ぐために、組み換えアルブミンを使用し得ることが示された。この実施例では、凍結乾燥工程においても、おそらく表面吸着によるタンパク質の活性喪失を、組み換えアルブミンが保護するかどうかを調査する。
上記の実験の項の記載に従って、組み換え第VIII因子を調製した。ここでの製剤は、非イオン性洗浄剤を含まないが、おそらく表面吸着による活性喪失を防ぐために、組み換えアルブミンが添加されている。凍結/凍結乾燥防止剤はスクロースであり、増量剤およびイオン強度プロバイダーとして塩化ナトリウムを使用する。表Xに示す製剤について、凍結乾燥製剤中の第VIII因子の回収率を、第VIII因子の初期濃度160 IU/mlで調査した。
この実施例では、pH緩衝剤を含まない溶液と比較した、pH緩衝剤としてヒスチジンを含有する溶液中の第VIII因子活性回収率を調査する。
上記の実験の項の記載に従って、組み換え第VIII因子を調製した。この実験では、凍結/凍結乾燥防止剤、増量剤およびイオン強度プロバイダーとしてアルギニンを有する製剤を調査する。製剤について、凍結乾燥製剤中の第VIII因子の回収率を、第VIII因子の初期濃度160 IU/mlで調査した。調査した組成を表XVに示す。
Claims (13)
- 組み換えr-第VIII因子;
3mg/ml〜15mg/mlのアルギニンおよび3mg/ml〜15mg/mlのスクロース、ここでアルギニンおよびスクロースの合計量は少なくとも6mg/mlであり;
r-第VIII因子の表面吸着を阻害するか、または少なくとも阻害するための界面活性剤、ここで前記界面活性剤は、0.5mg/ml〜5mg/mlのアルブミンを含み;
r-第VIII因子を特異的に安定化するための量の塩化カルシウム;
10mg/ml〜40mg/mlの塩化ナトリウム;
を含むヒスチジンフリー組成物。 - 3mg/ml〜10mg/mlのスクロースおよび3mg/ml〜8mg/mlのアルギニンを含む請求項1に記載の組成物。
- 組み換えr-第VIII因子;
5mg/ml〜25mg/mlのスクロースおよび20mg/ml〜70mg/mlのアルギニン;
r-第VIII因子の表面吸着を阻害するか、または少なくとも阻害するための界面活性剤、ここで前記界面活性剤は、0.5mg/ml〜5mg/mlのアルブミンを含み;
r-第VIII因子を特異的に安定化するための量の塩化カルシウム;
0%以上1%未満の塩化ナトリウム;
を含むヒスチジンフリー組成物。 - 前記界面活性剤は、1mg/ml〜4mg/mlのアルブミンを含む、請求項1〜3のいずれか1項に記載の組成物。
- 前記界面活性剤は、4mg/mlのアルブミンを含む、請求項1〜4のいずれか1項に記載の組成物。
- 前記界面活性剤は、2mg/mlのアルブミンを含む、請求項1〜4のいずれか1項に記載の組成物。
- 前記界面活性剤は、1mg/mlのアルブミンを含む、請求項1〜4のいずれか1項に記載の組成物。
- r-第VIII因子は内因性第VIII因子の欠失誘導体であり、内因性第VIII因子のB-ドメインを部分的に、または完全に失欠している、請求項1〜7のいずれか1項に記載の組成物。
- 凍結乾燥された形態である請求項1〜8のいずれか1項に記載の組成物。
- 凍結乾燥される溶液の形態、または凍結乾燥組成物および希釈剤から調製された再構成溶液の形態である請求項1〜8のいずれか1項に記載の組成物。
- 界面活性剤がポリオキシエチレン−ポリオキシプロピレン共重合体を更に含む、請求項1〜10のいずれか1項に記載の組成物。
- 界面活性剤がポリオキシエチレン−ポリオキシプロピレン共重合体を臨界ミセル濃度以下(below)の濃度で含む、請求項11に記載の組成物。
- r-第VIII因子の比活性度は1mgタンパクあたり5000IU以上である、請求項1〜12のいずれか1項に記載の組成物。
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US13640208P | 2008-09-03 | 2008-09-03 | |
EP08163554 | 2008-09-03 | ||
EP08163554.2 | 2008-09-03 | ||
US61/136,402 | 2008-09-03 |
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JP2011525549A Division JP5960990B2 (ja) | 2008-09-03 | 2009-09-03 | 組み換え技術によって製造された第viii因子のための新規な保護組成物 |
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JP2015129158A JP2015129158A (ja) | 2015-07-16 |
JP6010155B2 true JP6010155B2 (ja) | 2016-10-19 |
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JP2011525549A Active JP5960990B2 (ja) | 2008-09-03 | 2009-09-03 | 組み換え技術によって製造された第viii因子のための新規な保護組成物 |
JP2015031889A Expired - Fee Related JP6010155B2 (ja) | 2008-09-03 | 2015-02-20 | 組み換え技術によって製造された第viii因子のための新規な保護組成物 |
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JP2011525549A Active JP5960990B2 (ja) | 2008-09-03 | 2009-09-03 | 組み換え技術によって製造された第viii因子のための新規な保護組成物 |
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Country | Link |
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US (4) | US20110178019A1 (ja) |
EP (1) | EP2337580B1 (ja) |
JP (2) | JP5960990B2 (ja) |
KR (3) | KR20110073434A (ja) |
CN (3) | CN107050437A (ja) |
AT (1) | ATE551050T1 (ja) |
AU (1) | AU2009289212B2 (ja) |
BR (1) | BRPI0918589B1 (ja) |
CA (1) | CA2735376C (ja) |
DK (1) | DK2337580T3 (ja) |
ES (1) | ES2382443T3 (ja) |
IL (1) | IL211083A (ja) |
MX (1) | MX2011002316A (ja) |
PL (1) | PL2337580T3 (ja) |
PT (1) | PT2337580E (ja) |
RU (1) | RU2510279C3 (ja) |
SI (1) | SI2337580T1 (ja) |
WO (1) | WO2010026186A1 (ja) |
ZA (1) | ZA201101605B (ja) |
Families Citing this family (11)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
EP1820516B1 (en) | 1999-02-22 | 2013-07-24 | University of Connecticut | Novel albumin-free factor VIII formulations |
CA2742328C (en) | 2008-11-07 | 2019-02-26 | Baxter International Inc. | Factor viii formulations |
CN102232932B (zh) * | 2010-04-27 | 2013-06-05 | 重庆莱美药业股份有限公司 | 果胶-阿霉素轭合物的冻干制剂及制备方法 |
CA2918369C (en) * | 2013-07-18 | 2021-06-29 | Mannkind Corporation | Heat-stable dry powder pharmaceutical compositions and methods |
EP3097118B1 (en) | 2014-01-20 | 2018-07-18 | Octapharma AG | A process for manufacturing factor viii having an improved ratio of fviii:c/fviii:ag |
MX2017000862A (es) * | 2014-08-04 | 2017-05-01 | Csl Ltd | Formulacion de factor viii. |
CN113171447B (zh) | 2014-08-20 | 2024-05-17 | 博尔托拉制药公司 | Xa因子解毒剂的冻干制剂 |
US20190046450A1 (en) * | 2016-02-24 | 2019-02-14 | Portola Pharmaceuticals, Inc. | Lyophilized formulations for factor xa antidote |
EP3443346B1 (en) * | 2016-04-13 | 2023-08-30 | Medimmune, LLC | Use of amino acids as stabilizing compounds in pharmaceutical compositions containing high concentrations of protein-based therapeutic agents |
EP4013389A1 (en) | 2019-08-16 | 2022-06-22 | Octapharma AG | Stabilizing buffer for factor viii and vwf |
CN116479088A (zh) * | 2022-11-15 | 2023-07-25 | 江苏默乐生物科技股份有限公司 | 一种生物试剂冻干保存的试剂组合、试剂盒、方法及应用 |
Family Cites Families (23)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US5605884A (en) * | 1987-10-29 | 1997-02-25 | Rhone-Poulenc Rorer Pharmaceuticals Inc. | Factor VIII formulations in high ionic strength media |
US4877608A (en) * | 1987-11-09 | 1989-10-31 | Rorer Pharmaceutical Corporation | Pharmaceutical plasma protein formulations in low ionic strength media |
DE4001451A1 (de) * | 1990-01-19 | 1991-08-01 | Octapharma Ag | Stabile injizierbare loesungen von faktor viii und faktor ix |
DE4111393A1 (de) * | 1991-04-09 | 1992-10-15 | Behringwerke Ag | Stabilisierte faktor viii-praeparationen |
US5288853A (en) * | 1992-04-30 | 1994-02-22 | Alpha Therapeutic Corporation | Factor viii purification process |
NZ256921A (en) * | 1992-10-02 | 1996-05-28 | Pharmacia Ab | Formulations of coagulation factor viii and a non-ionic surfactant and their preparation |
SE9301581D0 (sv) * | 1993-05-07 | 1993-05-07 | Kabi Pharmacia Ab | Protein formulation |
SE9403915D0 (sv) * | 1994-11-14 | 1994-11-14 | Annelie Almstedt | Process A |
US5763401A (en) * | 1996-07-12 | 1998-06-09 | Bayer Corporation | Stabilized albumin-free recombinant factor VIII preparation having a low sugar content |
US6005007A (en) * | 1997-07-18 | 1999-12-21 | Farmer; Luc J. | Retinoids, methods for their production and use |
US6358703B1 (en) * | 1998-12-10 | 2002-03-19 | Bayer Corporation | Expression system for factor VIII |
EP1820516B1 (en) * | 1999-02-22 | 2013-07-24 | University of Connecticut | Novel albumin-free factor VIII formulations |
ATE264340T1 (de) * | 1999-08-17 | 2004-04-15 | Novo Nordisk Healthcare Ag | Stabilisierung von gefriergetrocknetem kuchen |
SE0004086D0 (sv) * | 2000-11-08 | 2000-11-08 | Pharmacia Ab | Preparation process |
GB0207092D0 (en) * | 2002-03-26 | 2002-05-08 | Sod Conseils Rech Applic | Stable pharmaceutical composition containing factor VIII |
KR101235507B1 (ko) * | 2003-02-28 | 2013-02-20 | 추가이 세이야쿠 가부시키가이샤 | 단백질을 함유하는 안정화 제제 |
KR100624013B1 (ko) * | 2004-06-25 | 2006-09-19 | 주식회사 녹십자홀딩스 | 동결건조된 알부민 비함유 재조합 사람 혈액응고 제 8인자 제제 |
JP2008534559A (ja) * | 2005-04-01 | 2008-08-28 | ノボ ノルディスク ヘルス ケア アクチェンゲゼルシャフト | 血液凝固fviii類似体 |
CN101415445A (zh) * | 2006-03-31 | 2009-04-22 | 巴克斯特国际公司 | 聚乙二醇化的因子ⅷ |
WO2008073620A2 (en) * | 2006-11-02 | 2008-06-19 | Neose Technologies, Inc. | Manufacturing process for the production of polypeptides expressed in insect cell-lines |
WO2009006301A2 (en) * | 2007-06-29 | 2009-01-08 | Battelle Memorial Institute | Protein stabilization |
KR20160104740A (ko) * | 2008-06-24 | 2016-09-05 | 옥타파마 아게 | 응고 인자 viii을 정제하는 방법 |
JP2012503637A (ja) * | 2008-09-24 | 2012-02-09 | スタビリテック リミテッド | 糖およびポリエチレンイミンを使用するポリペプチドの保存方法 |
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