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AR034226A2 - Procedimiento perfeccionado para estabilizar proteinas. - Google Patents

Procedimiento perfeccionado para estabilizar proteinas.

Info

Publication number
AR034226A2
AR034226A2 ARP020101691A ARP020101691A AR034226A2 AR 034226 A2 AR034226 A2 AR 034226A2 AR P020101691 A ARP020101691 A AR P020101691A AR P020101691 A ARP020101691 A AR P020101691A AR 034226 A2 AR034226 A2 AR 034226A2
Authority
AR
Argentina
Prior art keywords
protein
compartments
solution
stabilize proteins
buffered
Prior art date
Application number
ARP020101691A
Other languages
English (en)
Original Assignee
Boehringer Mannheim Gmbh
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=26145913&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=AR034226(A2) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Boehringer Mannheim Gmbh filed Critical Boehringer Mannheim Gmbh
Publication of AR034226A2 publication Critical patent/AR034226A2/es

Links

Classifications

    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12N—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
    • C12N9/00—Enzymes; Proenzymes; Compositions thereof; Processes for preparing, activating, inhibiting, separating or purifying enzymes
    • C12N9/96—Stabilising an enzyme by forming an adduct or a composition; Forming enzyme conjugates
    • 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
    • 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
    • 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
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/19—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles lyophilised, i.e. freeze-dried, solutions or dispersions
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10S—TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10S435/00—Chemistry: molecular biology and microbiology
    • Y10S435/963—Methods of stopping an enzyme reaction or stabilizing the test materials

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Epidemiology (AREA)
  • Organic Chemistry (AREA)
  • Genetics & Genomics (AREA)
  • Zoology (AREA)
  • Wood Science & Technology (AREA)
  • Microbiology (AREA)
  • Molecular Biology (AREA)
  • Biochemistry (AREA)
  • Biomedical Technology (AREA)
  • Biotechnology (AREA)
  • Inorganic Chemistry (AREA)
  • General Engineering & Computer Science (AREA)
  • Dermatology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Immunology (AREA)
  • Mycology (AREA)
  • Medicinal Preparation (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Peptides Or Proteins (AREA)
  • Agricultural Chemicals And Associated Chemicals (AREA)

Abstract

Un procedimiento perfeccionado para prevenir la formación de agregados de proteína de un liofilizado reconstituido de una composición farmacéutica de una proteína, en el cual una solución acuosa tamponada de la proteína se congela, se descongela, se divide en compartimientos de cantidades inyectables y dichos compartimientos se liofilizan, y el cual se caracteriza porque la solución acuosa tamponada de la proteína contiene tampón de fosfato de potasio como sustancia tampón y la relación de iones potasio a iones sodio en la solución es como mínimo de 10:1, puede emplearse ventajosamente para producir liofilizados estables de composiciones farmacéuticas.
ARP020101691A 1997-11-22 2002-05-09 Procedimiento perfeccionado para estabilizar proteinas. AR034226A2 (es)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
EP97120528 1997-11-22
EP98102846 1998-02-19

Publications (1)

Publication Number Publication Date
AR034226A2 true AR034226A2 (es) 2004-02-04

Family

ID=26145913

Family Applications (2)

Application Number Title Priority Date Filing Date
ARP980105921A AR018020A1 (es) 1997-11-22 1998-11-20 Procedimiento perfeccionado para estabilizar proteinas particularmente anticuerpos, su almacenamiento y reconstitucion
ARP020101691A AR034226A2 (es) 1997-11-22 2002-05-09 Procedimiento perfeccionado para estabilizar proteinas.

Family Applications Before (1)

Application Number Title Priority Date Filing Date
ARP980105921A AR018020A1 (es) 1997-11-22 1998-11-20 Procedimiento perfeccionado para estabilizar proteinas particularmente anticuerpos, su almacenamiento y reconstitucion

Country Status (16)

Country Link
US (1) US6238664B1 (es)
EP (1) EP0917879B1 (es)
JP (1) JP3105494B2 (es)
KR (1) KR100315908B1 (es)
CN (1) CN1220270A (es)
AR (2) AR018020A1 (es)
AT (1) ATE220558T1 (es)
AU (1) AU714264B2 (es)
BR (1) BRPI9805021B8 (es)
CA (1) CA2254145C (es)
DE (1) DE59804785D1 (es)
DK (1) DK0917879T3 (es)
ES (1) ES2179414T3 (es)
PT (1) PT917879E (es)
TR (1) TR199802394A2 (es)
ZA (1) ZA9810650B (es)

Families Citing this family (22)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
TW570805B (en) 1998-09-01 2004-01-11 Hoffmann La Roche Water-soluble pharmaceutical composition in an ionic complex
US7780967B2 (en) * 2000-02-08 2010-08-24 Allergan, Inc. Reduced toxicity Clostridial toxin pharmaceutical compositions
EP1253932B1 (en) * 2000-02-08 2005-04-27 Allergan, Inc. Botulinum toxin pharmaceutical compositions
US20060269575A1 (en) * 2000-02-08 2006-11-30 Allergan, Inc. Botulinum toxin pharmaceutical compositions formulated with recombinant albumin
US20030118598A1 (en) * 2000-02-08 2003-06-26 Allergan, Inc. Clostridial toxin pharmaceutical compositions
US8632785B2 (en) * 2000-02-08 2014-01-21 Allergan, Inc. Clostridial toxin pharmaceutical composition containing a gelatin fragment
DE10149030A1 (de) * 2001-10-05 2003-04-10 Viscum Ag Stabile galenische gefriergetrocknete Arzneimittelzubereitung von rViscumin
US20040185040A1 (en) * 2001-11-21 2004-09-23 Celltech R & D Limited Modulating immune responses
US20030175827A1 (en) * 2002-03-14 2003-09-18 Stillman Brett A. Stable thin film dried protein composition or device and related methods
US20040033228A1 (en) 2002-08-16 2004-02-19 Hans-Juergen Krause Formulation of human antibodies for treating TNF-alpha associated disorders
JP4607010B2 (ja) * 2003-02-28 2011-01-05 中外製薬株式会社 タンパク質含有安定化製剤
EP1909838A2 (en) * 2005-07-29 2008-04-16 Amgen Inc. Formulations that inhibit protein aggregation
KR20090069330A (ko) * 2006-10-12 2009-06-30 와이어쓰 유백광/응집체를 감소시키기 위한 항체 용액 중의 이온 강도의 변화
KR20120027031A (ko) * 2009-06-18 2012-03-20 와이어쓰 엘엘씨 소형 모듈 면역제약용 동결건조 제제
PE20150964A1 (es) 2012-09-07 2015-07-25 Coherus Biosciences Inc Formulaciones acuosas estables de adalimumab
JP2017531446A (ja) * 2014-09-29 2017-10-26 クック・ジェネラル・バイオテクノロジー・エルエルシー 細胞懸濁液中のトレハロースの使用
US11229702B1 (en) 2015-10-28 2022-01-25 Coherus Biosciences, Inc. High concentration formulations of adalimumab
US11071782B2 (en) 2016-04-20 2021-07-27 Coherus Biosciences, Inc. Method of filling a container with no headspace
EP3558363A1 (en) 2016-12-21 2019-10-30 Amgen Inc. Anti-tnf alpha antibody formulations
US11110063B2 (en) 2017-08-25 2021-09-07 MAIA Pharmaceuticals, Inc. Storage stable sincalide formulations
AU2021267900A1 (en) 2020-05-08 2023-01-19 Gallant Pet Inc. Uterine-derived regenerative cell compositions and uses thereof
CN111781345A (zh) * 2020-06-30 2020-10-16 上海透景生命科技股份有限公司 化学发光标记物标记抗原稳定剂及其应用

Family Cites Families (14)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE2652636A1 (de) 1976-11-19 1978-05-24 Hans Uwe Dr Rer Nat Wolf Verfahren zur stabilisierung von proteinen und verwandten verbindungen waehrend ihrer reinigung, isolierung und lagerung
US4783441A (en) 1979-04-30 1988-11-08 Hoechst Aktiengesellschaft Aqueous protein solutions stable to denaturation
EP0018609B1 (de) 1979-04-30 1983-09-21 Hoechst Aktiengesellschaft Gegen Denaturierung beständige, wässrige Protein-Lösungen, Verfahren zu ihrer Herstellung und ihre Verwendung
US4362661A (en) 1979-08-09 1982-12-07 Teijin Limited Immunoglobulin composition having a high monomer content, and process for production thereof
CA1329760C (en) 1987-10-29 1994-05-24 Ted C. K. Lee Plasma and recombinant protein formulations in high ionic strength media
GB8726136D0 (en) * 1987-11-07 1987-12-09 Wellcome Found Therapeutic nucleosides
US4877608A (en) 1987-11-09 1989-10-31 Rorer Pharmaceutical Corporation Pharmaceutical plasma protein formulations in low ionic strength media
EP0318081B1 (en) 1987-11-27 1991-07-24 Akzo N.V. Stabilization of antibodies
GB8920534D0 (en) * 1989-09-11 1989-10-25 Wellcome Found Antiviral compounds
US5164296A (en) * 1990-08-31 1992-11-17 University Of Maryland At Baltimore Assay methods involving ouabain
DE4126983A1 (de) * 1991-08-15 1993-02-18 Boehringer Mannheim Gmbh Verfahren zur herstellung von humanprotein-enthaltenden, konservierten arzneimitteln fuer infusions- oder injektionszwecke
GB9401447D0 (en) 1994-01-26 1994-03-23 Ciba Geigy Ag Pharmaceutical compositions
RU2109290C1 (ru) * 1996-04-09 1998-04-20 Государственный научный центр вирусологии и биотехнологии "Вектор" Стабилизирующий состав для получения лиофилизированных препаратов на основе конъюгата антииммуноглобулина g и пероксидазы хрена
EP0852951A1 (de) * 1996-11-19 1998-07-15 Roche Diagnostics GmbH Stabile lyophilisierte pharmazeutische Zubereitungen von mono- oder polyklonalen Antikörpern

Also Published As

Publication number Publication date
CN1220270A (zh) 1999-06-23
BRPI9805021A (pt) 2000-03-21
TR199802394A3 (tr) 1999-06-21
EP0917879B1 (de) 2002-07-17
PT917879E (pt) 2002-12-31
CA2254145C (en) 2002-10-08
ATE220558T1 (de) 2002-08-15
DK0917879T3 (da) 2002-11-04
AR018020A1 (es) 2001-10-31
BRPI9805021B8 (pt) 2021-07-06
EP0917879A3 (de) 1999-06-09
KR100315908B1 (ko) 2002-04-24
CA2254145A1 (en) 1999-05-22
BRPI9805021B1 (pt) 2011-05-31
AU714264B2 (en) 1999-12-23
EP0917879A2 (de) 1999-05-26
JPH11240895A (ja) 1999-09-07
AU9406098A (en) 1999-06-10
JP3105494B2 (ja) 2000-10-30
KR19990045460A (ko) 1999-06-25
DE59804785D1 (de) 2002-08-22
US6238664B1 (en) 2001-05-29
TR199802394A2 (xx) 1999-06-21
ZA9810650B (en) 1999-05-24
ES2179414T3 (es) 2003-01-16

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