DE69733664D1 - Verfahren zur INaktivierung von Viren und Lyophilisierung von Blutproteinen - Google Patents

Verfahren zur INaktivierung von Viren und Lyophilisierung von Blutproteinen

Info

Publication number
DE69733664D1
DE69733664D1 DE69733664T DE69733664T DE69733664D1 DE 69733664 D1 DE69733664 D1 DE 69733664D1 DE 69733664 T DE69733664 T DE 69733664T DE 69733664 T DE69733664 T DE 69733664T DE 69733664 D1 DE69733664 D1 DE 69733664D1
Authority
DE
Germany
Prior art keywords
factor viii
blood proteins
cyclodextrin
inactivating viruses
lyophilized
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
Application number
DE69733664T
Other languages
English (en)
Other versions
DE69733664T2 (de
DE69733664T3 (de
Inventor
Prabir Bhattacharya
Toshiharu Motokubota
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Grifols Shared Services North America Inc
Original Assignee
Alpha Therapeutic Corp
Priority date (The priority date 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 date listed.)
Filing date
Publication date
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=24545689&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=DE69733664(D1) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Alpha Therapeutic Corp filed Critical Alpha Therapeutic Corp
Publication of DE69733664D1 publication Critical patent/DE69733664D1/de
Publication of DE69733664T2 publication Critical patent/DE69733664T2/de
Application granted granted Critical
Publication of DE69733664T3 publication Critical patent/DE69733664T3/de
Anticipated expiration legal-status Critical
Expired - Lifetime legal-status Critical Current

Links

Classifications

    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K14/00Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • C07K14/435Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • C07K14/745Blood coagulation or fibrinolysis factors
    • C07K14/755Factors VIII, e.g. factor VIII C (AHF), factor VIII Ag (VWF)
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2/00Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor
    • A61L2/0005Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor for pharmaceuticals, biologicals or living parts
    • A61L2/0011Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor for pharmaceuticals, biologicals or living parts using physical methods
    • A61L2/0023Heat
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K1/00General methods for the preparation of peptides, i.e. processes for the organic chemical preparation of peptides or proteins of any length
    • C07K1/14Extraction; Separation; Purification
    • C07K1/30Extraction; Separation; Purification by precipitation
    • C07K1/32Extraction; Separation; Purification by precipitation as complexes
DE69733664T 1996-04-19 1997-04-17 Verfahren zur INaktivierung von Viren und Lyophilisierung von Blutproteinen Expired - Lifetime DE69733664T3 (de)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US63492196A 1996-04-19 1996-04-19
US634921 1996-04-19
PCT/US1997/006585 WO1997039761A1 (en) 1996-04-19 1997-04-17 A process for viral inactivation of lyophilized blood proteins

Publications (3)

Publication Number Publication Date
DE69733664D1 true DE69733664D1 (de) 2005-08-04
DE69733664T2 DE69733664T2 (de) 2005-12-15
DE69733664T3 DE69733664T3 (de) 2011-04-14

Family

ID=24545689

Family Applications (1)

Application Number Title Priority Date Filing Date
DE69733664T Expired - Lifetime DE69733664T3 (de) 1996-04-19 1997-04-17 Verfahren zur INaktivierung von Viren und Lyophilisierung von Blutproteinen

Country Status (8)

Country Link
US (1) US6566504B2 (de)
EP (1) EP0954326B2 (de)
JP (1) JP2000509374A (de)
AT (1) ATE298582T1 (de)
CA (1) CA2252374C (de)
DE (1) DE69733664T3 (de)
ES (1) ES2243994T5 (de)
WO (1) WO1997039761A1 (de)

Families Citing this family (11)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US8735374B2 (en) * 2009-07-31 2014-05-27 Intelgenx Corp. Oral mucoadhesive dosage form
US10610528B2 (en) 2009-12-08 2020-04-07 Intelgenx Corp. Solid oral film dosage forms and methods for making same
US20110136815A1 (en) * 2009-12-08 2011-06-09 Horst Zerbe Solid oral film dosage forms and methods for making same
US7989593B1 (en) 2010-05-27 2011-08-02 Bing Lou Wong Method for the preparation of a high-temperature stable oxygen-carrier-containing pharmaceutical composition and the use thereof
US7932356B1 (en) 2010-06-23 2011-04-26 Bing Lou Wong Method for the preparation of a heat stable oxygen carrier-containing pharmaceutical composition
US8048856B1 (en) 2010-06-23 2011-11-01 Billion King, Ltd. Treatment methods using a heat stable oxygen carrier-containing pharmaceutical composition
US8084581B1 (en) 2011-04-29 2011-12-27 Bing Lou Wong Method for removing unmodified hemoglobin from cross-linked hemoglobin solutions including polymeric hemoglobin with a high temperature short time heat treatment apparatus
US20130052232A1 (en) 2011-08-31 2013-02-28 Bing Lou Wong Method for the preparation of a heat stable oxygen carrier-containing composition facilating beta-beta cross-linking
AR107262A1 (es) * 2016-01-27 2018-04-11 Lilly Co Eli Inactivación de patógenos por delipidación
JP7110360B2 (ja) 2017-10-09 2022-08-01 テルモ ビーシーティー バイオテクノロジーズ,エルエルシー 凍結乾燥方法
JP2022525742A (ja) 2019-03-14 2022-05-19 テルモ ビーシーティー バイオテクノロジーズ,エルエルシー 凍結乾燥用ローディングトレイ組立体及びシステム

Family Cites Families (64)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE1073306B (de) 1958-05-07 1960-01-14 General Aniline ß. Film Corporation, New York, N Y. (V St A) Bildempfangsmaterial zur Verwendung im photographischen Silbersalzdiffusions-Ubertragungsverfahren und Verfahren zu dessen Herstellung
US3459731A (en) 1966-12-16 1969-08-05 Corn Products Co Cyclodextrin polyethers and their production
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
US4178454A (en) 1978-10-11 1979-12-11 Toray Industries, Inc. Stabilized prostaglandin E composition
DE2916711A1 (de) 1979-04-25 1980-11-06 Behringwerke Ag Blutgerinnungsfaktoren und verfahren zu ihrer herstellung
US4369184A (en) 1980-01-24 1983-01-18 Janssen Pharmaceutica N.V. 1-(Cyclohexyl)-4-aryl-4-piperidinecarboxylic acid derivatives
HU181703B (en) 1980-05-09 1983-11-28 Chinoin Gyogyszer Es Vegyeszet Process for producing aqueus solutuins of water insoluble or hardly soluble vitamines, steroides, localanesthetics, prostanoides and non-steroid and antiphlogistic agents
US4371673A (en) 1980-07-21 1983-02-01 The United States Of America As Represented By The Secretary Of The Department Of Health And Human Services Water soluble forms of retinoids
US4359463A (en) 1980-11-26 1982-11-16 Rock Gail A Stabilization of Factor VIII activity in whole blood or blood plasma
US4495278A (en) * 1981-04-27 1985-01-22 Baxter Travenol Laboratories, Inc. Process for making novel blood clotting enzyme compositions
DE3203775A1 (de) 1982-02-04 1983-08-11 Behringwerke Ag, 3550 Marburg Fibrinogenzubereitung, verfahen zu ihrer herstellungund ihre verwendung
US4659696A (en) 1982-04-30 1987-04-21 Takeda Chemical Industries, Ltd. Pharmaceutical composition and its nasal or vaginal use
US4511651A (en) 1982-07-30 1985-04-16 American Monitor Corporation Reagent composition and assay for the determination of γ-glutamyltransferase activity
JPS59104556A (ja) 1982-12-07 1984-06-16 Sekisui Chem Co Ltd 蛋白質安定化剤
US4751095A (en) 1983-07-28 1988-06-14 Karl Curtis L Aspartame stabilization with cyclodextrin
DE3346123A1 (de) 1983-12-21 1985-06-27 Janssen Pharmaceutica, N.V., Beerse Pharmazeutische praeparate von in wasser schwerloeslichen oder instabilen arzneistoffen und verfahren zu ihrer herstellung
US5281579A (en) * 1984-03-23 1994-01-25 Baxter International Inc. Purified virus-free hemoglobin solutions and method for making same
US4596795A (en) 1984-04-25 1986-06-24 The United States Of America As Represented By The Secretary, Dept. Of Health & Human Services Administration of sex hormones in the form of hydrophilic cyclodextrin derivatives
US4727064A (en) 1984-04-25 1988-02-23 The United States Of America As Represented By The Department Of Health And Human Services Pharmaceutical preparations containing cyclodextrin derivatives
JPS61165322A (ja) 1985-01-14 1986-07-26 Microbial Chem Res Found スパガリン類の注射用凍結乾燥製剤
JPS61194034A (ja) 1985-02-25 1986-08-28 Teijin Ltd 経鼻投与用粉末状組成物
GB8506792D0 (en) 1985-03-15 1985-04-17 Janssen Pharmaceutica Nv Derivatives of y-cyclodextrin
US4870060A (en) 1985-03-15 1989-09-26 Janssen Pharmaceutica Derivatives of γ-cylodextrin
US4925678A (en) 1987-04-01 1990-05-15 Ranney David F Endothelial envelopment drug carriers
US4956274A (en) 1987-04-06 1990-09-11 Microgenics Corporation Reagent stabilization in enzyme-donor and acceptor assay
NZ225045A (en) 1987-07-01 1990-06-26 Janssen Pharmaceutica Nv Antiviral pharmaceutical compositions containing cyclodextrin and an antiviral agent
US4877778A (en) 1987-07-01 1989-10-31 The Children's Medical Center Corporation Method of enhancing lipophile transport using cyclodextrin derivatives
US5221695A (en) 1987-12-22 1993-06-22 Glaxo Group Limited Aqueous formulation containing a piperidinylcyclopentylheptenoic acid derivative and beta-cyclodextrin
US5002935A (en) 1987-12-30 1991-03-26 University Of Florida Improvements in redox systems for brain-targeted drug delivery
US5183809A (en) 1990-02-15 1993-02-02 The Trustees Of The University Of Pennsylvania/Childrens Hospital Corporation Cyclodextrin polymers and cyclodextrins immobilized on a solid surface
CA1321192C (en) 1988-04-20 1993-08-10 Abdul Majid Inclusion complexes of cyclodextrins by agglomeration
US5997856A (en) * 1988-10-05 1999-12-07 Chiron Corporation Method and compositions for solubilization and stabilization of polypeptides, especially proteins
IT1227626B (it) 1988-11-28 1991-04-23 Vectorpharma Int Farmaci supportati aventi velocita' di dissoluzione aumentata e procedimento per la loro preparazione
US4971797A (en) 1988-12-22 1990-11-20 Warner-Lambert Company Stabilized sucralose complex
US5068227A (en) 1989-01-18 1991-11-26 Cyclex, Inc. Cyclodextrins as carriers
US5096893A (en) 1989-04-03 1992-03-17 The United States Of America As Represented By The Department Of Health And Human Services Regioselective substitutions in cyclodextrins
US5173481A (en) 1989-04-03 1992-12-22 The United States Of America As Represented By The Department Of Health And Human Services Preparation of specifically substituted cyclodextrins
USH1509H (en) * 1989-06-09 1995-12-05 Eran; Harutyun Heparin enhanced process for separating antihemophilic factor (Factor VIII) and fibronectin from cryoprecipitate
US5087461A (en) 1989-10-02 1992-02-11 Nabisco Brands, Inc. Double-encapsulated compositions containing volatile and/or labile components, and processes for preparation and use thereof
KR0166088B1 (ko) 1990-01-23 1999-01-15 . 수용해도가 증가된 시클로덱스트린 유도체 및 이의 용도
US5376645A (en) 1990-01-23 1994-12-27 University Of Kansas Derivatives of cyclodextrins exhibiting enhanced aqueous solubility and the use thereof
GB9001987D0 (en) 1990-01-29 1990-03-28 Janssen Pharmaceutica Nv Improved cyclodextrin based erythropietin formulation
FR2657545B1 (fr) * 1990-01-29 1992-08-14 Roquette Freres Procede de raffinage de melanges issus de traitements de milieux gras a l'aide de cyclodextrine et comprenant des complexes de cyclodextrine avec des composes lipophiles.
US5120720A (en) 1990-09-20 1992-06-09 The United States Of America As Represented By The Secretary Of The Department Of Health & Human Services Preparation of lipophile:hydroxypropylcyclodextrin complexes by a method using co-solubilizers
IL100856A (en) 1991-02-15 1998-03-10 Janssen Pharmaceutica Nv History of carboxyl (alkyloxyalkyl of cyclodextrins, their preparation and pharmaceutical preparations containing them
JPH04264020A (ja) 1991-02-18 1992-09-18 Yamanouchi Pharmaceut Co Ltd 安定な凍結乾燥製剤
JP2696613B2 (ja) 1991-03-08 1998-01-14 美穂 田中 養魚用飼料とその製造法
US5147756A (en) 1991-04-11 1992-09-15 E. I. Du Pont De Nemours And Company Stabilized, aqueous hydrazide solutions for photographic elements
US5221669A (en) 1991-04-19 1993-06-22 The United States Of America As Represented By The Department Of Health And Human Services Antiviral compositions containing α-cyclodextrin sulfates alone and in combination with other known antiviral agents and glucocorticoids and methods of treating viral infections
IT1255981B (it) 1991-04-30 1995-11-17 Ministero Dell Uni E Della Composizione adesiva a piu' componenti
AU678760B2 (en) * 1991-11-11 1997-06-12 Trustees Of The University Of Pennsylvania, The Methods of inhibiting restenosis
US5192743A (en) 1992-01-16 1993-03-09 Genentech, Inc. Reconstitutable lyophilized protein formulation
DE4204315A1 (de) 1992-02-13 1993-08-19 Consortium Elektrochem Ind Cyclodextringlycoside und verfahren zu ihrer herstellung
US5300280A (en) 1992-02-14 1994-04-05 Mallinckrodt Medical, Inc. Stabilized radiopharmaceutical kits
RU2127733C1 (ru) 1992-03-18 1999-03-20 Жансен Фармасетика Н.В. Стереоизомеры итраконазола или саперконазола, способ их получения, их комплексы и фармацевтическая композиция на их основе
US5348941A (en) 1992-04-01 1994-09-20 Merck & Co., Inc. Stabilizers for fibroblast growth factors
AU670793B2 (en) * 1992-04-30 1996-08-01 Alpha Therapeutic Corporation Improved solubilization and stabilization of factor VIII complex
US5324718A (en) 1992-07-14 1994-06-28 Thorsteinn Loftsson Cyclodextrin/drug complexation
US5298410A (en) * 1993-02-25 1994-03-29 Sterling Winthrop Inc. Lyophilized formulation of polyethylene oxide modified proteins with increased shelf-life
JPH0769887A (ja) 1993-07-09 1995-03-14 Takeda Chem Ind Ltd ペネム化合物含有固形組成物、その製造法および剤
PH31594A (en) 1993-09-30 1998-11-03 Janssen Pharmaceutica Nv Oral formulations on an antifungal.
IL113010A (en) * 1994-03-31 1999-10-28 Pharmacia & Upjohn Ab Pharmaceutical formulation comprising factor viii with an activity of at least 500iu/ml and an enhancer for improved subcutaneous intramuscular or intradermal administration
US5659017A (en) * 1995-11-07 1997-08-19 Alpha Therapeutic Corporation Anion exchange process for the purification of Factor VIII

Also Published As

Publication number Publication date
CA2252374A1 (en) 1997-10-30
WO1997039761A1 (en) 1997-10-30
ES2243994T3 (es) 2005-12-01
CA2252374C (en) 2007-08-07
DE69733664T2 (de) 2005-12-15
JP2000509374A (ja) 2000-07-25
EP0954326B1 (de) 2005-06-29
EP0954326B2 (de) 2009-07-22
DE69733664T3 (de) 2011-04-14
ATE298582T1 (de) 2005-07-15
EP0954326A4 (de) 2002-11-20
EP0954326A1 (de) 1999-11-10
US6566504B2 (en) 2003-05-20
ES2243994T5 (es) 2009-10-29
US20010047085A1 (en) 2001-11-29

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Legal Events

Date Code Title Description
8363 Opposition against the patent
8366 Restricted maintained after opposition proceedings
8327 Change in the person/name/address of the patent owner

Owner name: GRIFOLS INC., LOS ANGELES, CA, US

8327 Change in the person/name/address of the patent owner

Owner name: GRIFOLS INC. (N.D. GES.D.STAATES DELAWARE), LO, US