DE3871334D1 - Plasma- und rekombinationsproteinformulierungen in einem milieu niedriger ionenstaerke. - Google Patents
Plasma- und rekombinationsproteinformulierungen in einem milieu niedriger ionenstaerke.Info
- Publication number
- DE3871334D1 DE3871334D1 DE8888118649T DE3871334T DE3871334D1 DE 3871334 D1 DE3871334 D1 DE 3871334D1 DE 8888118649 T DE8888118649 T DE 8888118649T DE 3871334 T DE3871334 T DE 3871334T DE 3871334 D1 DE3871334 D1 DE 3871334D1
- Authority
- DE
- Germany
- Prior art keywords
- plasma
- milieu
- protein formulations
- low ion
- ion strength
- 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.)
- Expired - Lifetime
Links
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- 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
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K35/00—Medicinal preparations containing materials or reaction products thereof with undetermined constitution
- A61K35/12—Materials from mammals; Compositions comprising non-specified tissues or cells; Compositions comprising non-embryonic stem cells; Genetically modified cells
- A61K35/14—Blood; Artificial blood
- A61K35/16—Blood plasma; Blood serum
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K38/00—Medicinal preparations containing peptides
- A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
- A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
- A61K38/36—Blood coagulation or fibrinolysis factors
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K38/00—Medicinal preparations containing peptides
- A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
- A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
- A61K38/36—Blood coagulation or fibrinolysis factors
- A61K38/37—Factors VIII
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/02—Inorganic compounds
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
- 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
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P7/00—Drugs for disorders of the blood or the extracellular fluid
- A61P7/04—Antihaemorrhagics; Procoagulants; Haemostatic agents; Antifibrinolytic agents
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K14/00—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
- C07K14/435—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
- C07K14/745—Blood coagulation or fibrinolysis factors
- C07K14/755—Factors VIII, e.g. factor VIII C (AHF), factor VIII Ag (VWF)
Applications Claiming Priority (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US07/118,670 US4877608A (en) | 1987-11-09 | 1987-11-09 | Pharmaceutical plasma protein formulations in low ionic strength media |
Publications (1)
Publication Number | Publication Date |
---|---|
DE3871334D1 true DE3871334D1 (de) | 1992-06-25 |
Family
ID=22380039
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
DE8888118649T Expired - Lifetime DE3871334D1 (de) | 1987-11-09 | 1988-11-09 | Plasma- und rekombinationsproteinformulierungen in einem milieu niedriger ionenstaerke. |
Country Status (9)
Country | Link |
---|---|
US (1) | US4877608A (de) |
EP (1) | EP0315968B2 (de) |
JP (1) | JPH0676338B2 (de) |
AT (1) | ATE76304T1 (de) |
AU (1) | AU609899B2 (de) |
CA (1) | CA1329542C (de) |
DE (1) | DE3871334D1 (de) |
ES (1) | ES2042693T5 (de) |
GR (2) | GR3004891T3 (de) |
Families Citing this family (88)
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 |
JPH03215430A (ja) * | 1990-01-19 | 1991-09-20 | Kita Kiyoshi | 関節腔抗凝固剤 |
US5945098A (en) * | 1990-02-01 | 1999-08-31 | Baxter International Inc. | Stable intravenously-administrable immune globulin preparation |
DE4111393A1 (de) * | 1991-04-09 | 1992-10-15 | Behringwerke Ag | Stabilisierte faktor viii-praeparationen |
ES2233924T3 (es) * | 1991-06-20 | 2005-06-16 | Aventis Behring L.L.C. | Un procedimiento para preparar fragmentos terapeuticos de factor von willebrand. |
US5847086A (en) * | 1991-06-20 | 1998-12-08 | Centeon L.L.C. | Therapeutic fragments of von Willebrand factor |
EP1652534A3 (de) * | 1992-10-02 | 2007-05-02 | Genetics Institute, LLC | Zusammensetzung, welche den Koagulationsfaktor VIII beinhalted; Verfahren zu deren Herstellung und die Benutzung eines oberflächenaktiven Stoffes als Stabilisator |
US5395923A (en) * | 1993-02-23 | 1995-03-07 | Haemacure-Biotech, Inc. | Process for the obtention of a biological adhesive made of concentrated coagulation factors by "salting-out" |
JP3711561B2 (ja) * | 1993-04-05 | 2005-11-02 | 三菱ウェルファーマ株式会社 | アンチトロンビン−▲iii▼液状製剤およびその安定化方法 |
SE9301581D0 (sv) * | 1993-05-07 | 1993-05-07 | Kabi Pharmacia Ab | Protein formulation |
US5861163A (en) * | 1993-06-07 | 1999-01-19 | Cheil Jedang Corporation | Process for preparing a vaccine against pseudomonas aeruginosa using attenuated strains |
US6288030B1 (en) * | 1993-12-22 | 2001-09-11 | Amgen Inc. | Stem cell factor formulations and methods |
US6372716B1 (en) | 1994-04-26 | 2002-04-16 | Genetics Institute, Inc. | Formulations for factor IX |
SE9403915D0 (sv) * | 1994-11-14 | 1994-11-14 | Annelie Almstedt | Process A |
US7253262B2 (en) | 1995-01-19 | 2007-08-07 | Quandrant Drug Delivery Limited | Dried blood factor composition comprising trehalose |
GB9501040D0 (en) * | 1995-01-19 | 1995-03-08 | Quadrant Holdings Cambridge | Dried composition |
US7244824B2 (en) | 1995-01-19 | 2007-07-17 | Quadrant Drug Delivery Limited | Dried blood factor composition comprising trehalose |
US6685940B2 (en) | 1995-07-27 | 2004-02-03 | Genentech, Inc. | Protein formulation |
US6267958B1 (en) | 1995-07-27 | 2001-07-31 | Genentech, Inc. | Protein formulation |
TW518219B (en) * | 1996-04-26 | 2003-01-21 | Chugai Pharmaceutical Co Ltd | Erythropoietin solution preparation |
US5763401A (en) * | 1996-07-12 | 1998-06-09 | Bayer Corporation | Stabilized albumin-free recombinant factor VIII preparation having a low sugar content |
US6630137B1 (en) | 1997-04-28 | 2003-10-07 | Eli Lilly And Company | Activated protein C formulations |
PE84799A1 (es) * | 1997-04-28 | 1999-09-16 | Lilly Co Eli | Metodos mejorados para el procesamiento de proteina c activada |
EP1561469A1 (de) * | 1997-04-28 | 2005-08-10 | Eli Lilly & Company | Aktiviertes Protein C Formulierungen |
US6171586B1 (en) | 1997-06-13 | 2001-01-09 | Genentech, Inc. | Antibody formulation |
US6991790B1 (en) * | 1997-06-13 | 2006-01-31 | Genentech, Inc. | Antibody formulation |
PT917879E (pt) | 1997-11-22 | 2002-12-31 | Roche Diagnostics Gmbh | Processo melhorado para estabilizacao de proteinas |
PT2193809E (pt) * | 1999-02-22 | 2015-08-24 | Baxter Int | Formulações de fator viii livres de albumina |
US6586574B1 (en) * | 1999-08-17 | 2003-07-01 | Nn A/S | Stabilization of freeze-dried cake |
US7204981B2 (en) * | 2000-03-28 | 2007-04-17 | Eli Lilly And Company | Methods of treating diseases with activated protein C |
JP2004511428A (ja) | 2000-05-24 | 2004-04-15 | イーライ・リリー・アンド・カンパニー | 凝固亢進状態を処置するための製剤および方法 |
AU1344102A (en) * | 2000-10-12 | 2002-04-22 | Genentech Inc | Reduced-viscosity concentrated protein formulations |
US8703126B2 (en) | 2000-10-12 | 2014-04-22 | Genentech, Inc. | Reduced-viscosity concentrated protein formulations |
WO2003075834A2 (en) * | 2002-03-08 | 2003-09-18 | Eli Lilly And Company | Activated protein c formulations |
US20040033228A1 (en) | 2002-08-16 | 2004-02-19 | Hans-Juergen Krause | Formulation of human antibodies for treating TNF-alpha associated disorders |
JP4869064B2 (ja) | 2003-04-04 | 2012-02-01 | ジェネンテック, インコーポレイテッド | 高濃度抗体及びタンパク質製剤 |
US20050158303A1 (en) * | 2003-04-04 | 2005-07-21 | Genentech, Inc. | Methods of treating IgE-mediated disorders comprising the administration of high concentration anti-IgE antibody formulations |
CA2531988C (en) | 2003-08-05 | 2016-06-28 | Novo Nordisk A/S | Novel insulin derivatives |
US8541002B2 (en) | 2003-09-12 | 2013-09-24 | Agenus Inc. | Vaccine for treatment and prevention of herpes simplex virus infection |
PT1835938E (pt) * | 2004-12-27 | 2013-11-06 | Baxter Int | Conjugados de polímero-factor de von willebrand |
PT1969004E (pt) | 2005-12-28 | 2011-11-25 | Novo Nordisk As | Composições que compreendem uma insulina acilada e zinco e método para criar tais composições |
EP2010222A1 (de) * | 2006-03-31 | 2009-01-07 | Baxter International Inc. | Pegylierter faktor viii |
US7645860B2 (en) | 2006-03-31 | 2010-01-12 | Baxter Healthcare S.A. | Factor VIII polymer conjugates |
RU2476442C2 (ru) * | 2007-03-29 | 2013-02-27 | Эббот Лэборетриз | Кристаллические антитела против il-12 человека |
RU2469739C2 (ru) * | 2007-04-26 | 2012-12-20 | БАЙЕР ХЕЛСКЕА ЛЛСи | Стабилизация жидких растворов рекомбинантного белка для хранения в замороженном состоянии |
US9034818B2 (en) | 2007-06-13 | 2015-05-19 | Novo Nordisk A/S | Pharmaceutical formulations comprising an insulin derivative |
KR20190045414A (ko) * | 2007-11-30 | 2019-05-02 | 애브비 바이오테크놀로지 리미티드 | 단백질 제형 및 이의 제조방법 |
US8883146B2 (en) | 2007-11-30 | 2014-11-11 | Abbvie Inc. | Protein formulations and methods of making same |
AU2009240026B2 (en) * | 2008-04-21 | 2014-05-29 | Novo Nordisk Health Care Ag | Dry transglutaminase composition |
AU2009284113B2 (en) | 2008-08-21 | 2015-05-14 | Octapharma Ag | Recombinantly produced human factor VIII and IX |
EP2337580B1 (de) * | 2008-09-03 | 2012-03-28 | Octapharma AG | Stabilisierte zusammensetzungen für rekombinant hergestellten faktor viii |
JP5775820B2 (ja) * | 2008-10-21 | 2015-09-09 | バクスター・インターナショナル・インコーポレイテッドBaxter International Incorp0Rated | 遊離可能peg試薬を有するプロドラッグpegタンパク質結合体において活性成分(インビトロ脱ペグ化)を決定する方法 |
AU2009309623B9 (en) | 2008-10-30 | 2014-10-02 | Novo Nordisk A/S | Treating diabetes melitus using insulin injections with less than daily injection frequency |
BRPI0921429B1 (pt) * | 2008-11-07 | 2022-07-12 | Takeda Pharmaceutical Company Limited | Formulação farmacêutica liofilizada estável, e, método para preparar um fator liofilizado estável |
RU2011140498A (ru) * | 2009-03-06 | 2013-04-20 | Дженентек, Инк. | Препарат антител |
SI3345615T1 (sl) | 2010-03-01 | 2020-03-31 | Bayer Healthcare Llc | Optimizirana monoklonska protitelesa proti zaviralcu poti tkivnega faktorja (TFPI) |
CN102869679B (zh) | 2010-04-27 | 2015-11-25 | Scil技术股份有限公司 | 稳定的水性mia/cd-rap制剂 |
JP6049625B2 (ja) | 2010-10-27 | 2016-12-21 | ノヴォ ノルディスク アー/エス | 様々な注射間隔を用いて施されるインスリン注射を使用する、真性糖尿病の治療 |
EP2702077A2 (de) | 2011-04-27 | 2014-03-05 | AbbVie Inc. | Verfahren zur steuerung des galactosylierungsprofil von rekombinant exprimierten proteinen |
PE20191242A1 (es) | 2011-10-25 | 2019-09-16 | Prothena Biosciences Ltd | Formulaciones de anticuerpo y metodos |
CN102580062B (zh) * | 2012-03-09 | 2017-03-08 | 中国医学科学院输血研究所 | 人凝血因子VIII与vWF复合物或人凝血因子VIII制剂的干热处理稳定剂 |
WO2013158279A1 (en) | 2012-04-20 | 2013-10-24 | Abbvie Inc. | Protein purification methods to reduce acidic species |
WO2013158273A1 (en) | 2012-04-20 | 2013-10-24 | Abbvie Inc. | Methods to modulate c-terminal lysine variant distribution |
US9067990B2 (en) | 2013-03-14 | 2015-06-30 | Abbvie, Inc. | Protein purification using displacement chromatography |
WO2013176754A1 (en) | 2012-05-24 | 2013-11-28 | Abbvie Inc. | Novel purification of antibodies using hydrophobic interaction chromatography |
US9592297B2 (en) | 2012-08-31 | 2017-03-14 | Bayer Healthcare Llc | Antibody and protein formulations |
US8613919B1 (en) | 2012-08-31 | 2013-12-24 | Bayer Healthcare, Llc | High concentration antibody and protein formulations |
AU2013309506A1 (en) | 2012-09-02 | 2015-03-12 | Abbvie Inc. | Methods to control protein heterogeneity |
US9512214B2 (en) | 2012-09-02 | 2016-12-06 | Abbvie, Inc. | Methods to control protein heterogeneity |
US9212357B2 (en) | 2012-12-03 | 2015-12-15 | Omrix Biopharmaceuticals Ltd. | Thrombin solution and methods of use thereof |
SG11201507230PA (en) | 2013-03-12 | 2015-10-29 | Abbvie Inc | Human antibodies that bind human tnf-alpha and methods of preparing the same |
WO2014151878A2 (en) | 2013-03-14 | 2014-09-25 | Abbvie Inc. | Methods for modulating protein glycosylation profiles of recombinant protein therapeutics using monosaccharides and oligosacharides |
WO2014159579A1 (en) | 2013-03-14 | 2014-10-02 | Abbvie Inc. | MUTATED ANTI-TNFα ANTIBODIES AND METHODS OF THEIR USE |
US9017687B1 (en) | 2013-10-18 | 2015-04-28 | Abbvie, Inc. | Low acidic species compositions and methods for producing and using the same using displacement chromatography |
EP2991672A1 (de) | 2013-04-30 | 2016-03-09 | Novo Nordisk A/S | Neuartiges verabreichungsschema |
EP3052640A2 (de) | 2013-10-04 | 2016-08-10 | AbbVie Inc. | Verwendung von metallionen zur modulation von proteinglykosylierungsprofilen rekombinanter proteine |
US8946395B1 (en) | 2013-10-18 | 2015-02-03 | Abbvie Inc. | Purification of proteins using hydrophobic interaction chromatography |
US9181337B2 (en) | 2013-10-18 | 2015-11-10 | Abbvie, Inc. | Modulated lysine variant species compositions and methods for producing and using the same |
US9085618B2 (en) | 2013-10-18 | 2015-07-21 | Abbvie, Inc. | Low acidic species compositions and methods for producing and using the same |
WO2015073884A2 (en) | 2013-11-15 | 2015-05-21 | Abbvie, Inc. | Glycoengineered binding protein compositions |
AU2015299224B2 (en) | 2014-08-04 | 2019-06-20 | Csl Limited | Factor VIII formulation |
AU2016260540B2 (en) | 2015-05-13 | 2021-01-07 | Agenus Inc. | Vaccines for treatment and prevention of cancer |
CA3078625C (en) | 2017-10-09 | 2023-01-17 | Terumo Bct Biotechnologies, Llc | Lyophilization container and method of using same |
US11065317B2 (en) | 2018-04-26 | 2021-07-20 | Agenus Inc. | Heat shock protein-binding peptide compositions and methods of use thereof |
US10335464B1 (en) | 2018-06-26 | 2019-07-02 | Novo Nordisk A/S | Device for titrating basal insulin |
EP3938741B1 (de) | 2019-03-14 | 2024-05-01 | Terumo BCT Biotechnologies, LLC | Lyophilisierungsbehälterfüllvorrichtung, system und verfahren zur verwendung |
EP3994162A1 (de) | 2019-07-04 | 2022-05-11 | CSL Behring Lengnau AG | Gestutzter von-willebrand-faktor (vwf) zur erhöhung der in-vitro-stabilität des koagulationsfaktors viii |
EP4240757A2 (de) | 2020-11-09 | 2023-09-13 | Takeda Pharmaceutical Company Limited | Reinigung von fviii aus plasma mittels siliciumoxidadsorption |
Family Cites Families (8)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US32011A (en) * | 1861-04-09 | Coffee-pot | ||
US4188318A (en) * | 1975-06-16 | 1980-02-12 | Edward Shanbrom | Simplified method for preparation of high yield, high purity Factor VIII concentrate |
US4089944A (en) * | 1975-12-22 | 1978-05-16 | Baxter Travenol Laboratories, Inc. | Rapidly solubilized AHF composition and process for preparing same |
US4104266A (en) * | 1977-04-14 | 1978-08-01 | American National Red Cross | Method for preparation of antihemophilic factor |
JPS597693B2 (ja) * | 1978-01-07 | 1984-02-20 | 株式会社ミドリ十字 | 抗トロンビン製剤及びその製法 |
US4321192A (en) * | 1980-01-10 | 1982-03-23 | Ionics Incorporated | Fractionation of protein mixtures by salt addition followed by dialysis treatment |
USRE32011E (en) | 1981-12-14 | 1985-10-22 | Scripps Clinic And Research Foundation | Ultrapurification of factor VIII using monoclonal antibodies |
US4597966A (en) * | 1985-01-09 | 1986-07-01 | Ortho Diagnostic Systems, Inc. | Histidine stabilized immunoglobulin and method of preparation |
-
1987
- 1987-11-09 US US07/118,670 patent/US4877608A/en not_active Expired - Lifetime
-
1988
- 1988-11-01 CA CA000581910A patent/CA1329542C/en not_active Expired - Fee Related
- 1988-11-07 AU AU24788/88A patent/AU609899B2/en not_active Ceased
- 1988-11-08 JP JP63280549A patent/JPH0676338B2/ja not_active Expired - Fee Related
- 1988-11-09 ES ES88118649T patent/ES2042693T5/es not_active Expired - Lifetime
- 1988-11-09 DE DE8888118649T patent/DE3871334D1/de not_active Expired - Lifetime
- 1988-11-09 AT AT88118649T patent/ATE76304T1/de not_active IP Right Cessation
- 1988-11-09 EP EP88118649A patent/EP0315968B2/de not_active Expired - Lifetime
-
1992
- 1992-06-11 GR GR920401235T patent/GR3004891T3/el unknown
-
1997
- 1997-05-02 GR GR970400988T patent/GR3023329T3/el unknown
Also Published As
Publication number | Publication date |
---|---|
JPH0676338B2 (ja) | 1994-09-28 |
AU609899B2 (en) | 1991-05-09 |
EP0315968A1 (de) | 1989-05-17 |
EP0315968B2 (de) | 1997-04-09 |
JPH01157917A (ja) | 1989-06-21 |
US4877608A (en) | 1989-10-31 |
ATE76304T1 (de) | 1992-06-15 |
GR3023329T3 (en) | 1997-08-29 |
ES2042693T5 (es) | 1997-06-16 |
CA1329542C (en) | 1994-05-17 |
GR3004891T3 (en) | 1993-04-28 |
EP0315968B1 (de) | 1992-05-20 |
AU2478888A (en) | 1989-05-11 |
ES2042693T3 (es) | 1993-12-16 |
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Legal Events
Date | Code | Title | Description |
---|---|---|---|
8380 | Miscellaneous part iii |
Free format text: DER PATENTINHABER LAUTET RICHTIG: RHONE-POULENC RORER INTERNATIONAL (HOLDINGS) INC., LEWES, DEL., US |
|
8363 | Opposition against the patent | ||
8366 | Restricted maintained after opposition proceedings | ||
8339 | Ceased/non-payment of the annual fee |