BRPI9805021A - processo para estabilizar proteínas em um processo de congelamento e liofilização ou durante armazenagem em baixas temperaturas, forma de armazenagem e composição farmacêutica. - Google Patents

processo para estabilizar proteínas em um processo de congelamento e liofilização ou durante armazenagem em baixas temperaturas, forma de armazenagem e composição farmacêutica.

Info

Publication number
BRPI9805021A
BRPI9805021A BRPI9805021A BRPI9805021A BRPI9805021A BR PI9805021 A BRPI9805021 A BR PI9805021A BR PI9805021 A BRPI9805021 A BR PI9805021A BR PI9805021 A BRPI9805021 A BR PI9805021A BR PI9805021 A BRPI9805021 A BR PI9805021A
Authority
BR
Brazil
Prior art keywords
pharmaceutical composition
freeze
stabilizing proteins
low temperatures
storage
Prior art date
Application number
BRPI9805021A
Other languages
English (en)
Inventor
Klaus Hellerbrand
Apollon Papadimitriou
Gerhard Winter
Original Assignee
Roche Diagnostics 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=BRPI9805021(A) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Roche Diagnostics Gmbh filed Critical Roche Diagnostics Gmbh
Publication of BRPI9805021A publication Critical patent/BRPI9805021A/pt
Publication of BRPI9805021B1 publication Critical patent/BRPI9805021B1/pt
Publication of BRPI9805021B8 publication Critical patent/BRPI9805021B8/pt

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
    • 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
    • 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
    • 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
    • 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
    • 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)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Epidemiology (AREA)
  • Organic Chemistry (AREA)
  • Genetics & Genomics (AREA)
  • Zoology (AREA)
  • Wood Science & Technology (AREA)
  • Microbiology (AREA)
  • Molecular Biology (AREA)
  • General Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Biotechnology (AREA)
  • Biochemistry (AREA)
  • Inorganic Chemistry (AREA)
  • Dermatology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (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

patente de invenção: <b>"processo aperfeiçoado para estabilizar proteínas em um processo de congelamento ou liofilização ou durante armazenagem em baixas temperaturas"<d>. um processo aperfeiçoado para prevenir a formação de agregados de proteína em um liofilizado reconstrituído de uma composição farmacêutica de uma proteína, em que uma solução tamponada aquosa de proteína é congelada, descongelada, dividida em compartimentos de quantidades injetáveis, e estes compartimentos são liofilizados, que é caracterizado em que a solução tamponada aquosa de proteína contém tampão de fosfato de potássio como uma substância tampão e a razão de íons de potássio em relação a íons de sódio na solução é pelo menos 10:1, pode vantajosamente ser usada para produzir liofilizados estáveis de composições farmacêuticas.
BRPI9805021-4 1997-11-22 1998-11-23 processo para estabilizar proteìnas em um processo de congelamento e liofilização ou durante armazenagem em baixas temperaturas, forma de armazenagem e composição farmacêutica. BRPI9805021B8 (pt)

Applications Claiming Priority (2)

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

Publications (3)

Publication Number Publication Date
BRPI9805021A true BRPI9805021A (pt) 2000-03-21
BRPI9805021B1 BRPI9805021B1 (pt) 2011-05-31
BRPI9805021B8 BRPI9805021B8 (pt) 2021-07-06

Family

ID=26145913

Family Applications (1)

Application Number Title Priority Date Filing Date
BRPI9805021-4 BRPI9805021B8 (pt) 1997-11-22 1998-11-23 processo para estabilizar proteìnas em um processo de congelamento e liofilização ou durante armazenagem em baixas temperaturas, forma de armazenagem e composição farmacêutica.

Country Status (16)

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

Families Citing this family (20)

* 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
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
US7780967B2 (en) * 2000-02-08 2010-08-24 Allergan, Inc. Reduced toxicity Clostridial toxin pharmaceutical compositions
US8632785B2 (en) * 2000-02-08 2014-01-21 Allergan, Inc. Clostridial toxin pharmaceutical composition containing a gelatin fragment
ES2237551T3 (es) * 2000-02-08 2005-08-01 Allergan, Inc. Composiciones farmaceuticas que contienen toxina botulinica.
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
CA2517310C (en) 2003-02-28 2015-11-24 Chugai Seiyaku Kabushiki Kaisha Stabilized protein-containing formulations comprising a poloxamer
CA2615731A1 (en) * 2005-07-29 2007-02-08 Amgen Inc. Formulations that inhibit protein aggregation
MX2009003542A (es) * 2006-10-12 2009-04-15 Wyeth Corp Metodos y composiciones con opalescencia reducida.
WO2010148337A1 (en) * 2009-06-18 2010-12-23 Wyeth Llc Lyophilized formulations for small modular immunopharmaceuticals
PE20191815A1 (es) 2012-09-07 2019-12-27 Coherus Biosciences Inc Formulaciones acuosas estables de adalimumab
EP3201319A4 (en) * 2014-09-29 2018-05-16 Cook General Biotechnology LLC Uses of trehalose in cell suspensions
US11229702B1 (en) 2015-10-28 2022-01-25 Coherus Biosciences, Inc. High concentration formulations of adalimumab
WO2017184880A1 (en) 2016-04-20 2017-10-26 Coherus Biosciences, Inc. A method of filling a container with no headspace
US11110063B2 (en) 2017-08-25 2021-09-07 MAIA Pharmaceuticals, Inc. Storage stable sincalide formulations
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 (12)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4783441A (en) 1979-04-30 1988-11-08 Hoechst Aktiengesellschaft Aqueous protein solutions stable to denaturation
DE3064888D1 (en) 1979-04-30 1983-10-27 Hoechst Ag Aqueous solutions of proteins stable against denaturization, process for their manufacture, and their utilization
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
ATE65410T1 (de) 1987-11-27 1991-08-15 Akzo Nv Stabilisierung von antikoerpern.
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
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
ZA9810650B (en) 1999-05-24
JP3105494B2 (ja) 2000-10-30
TR199802394A3 (tr) 1999-06-21
CA2254145A1 (en) 1999-05-22
CA2254145C (en) 2002-10-08
EP0917879A2 (de) 1999-05-26
KR19990045460A (ko) 1999-06-25
AU9406098A (en) 1999-06-10
EP0917879B1 (de) 2002-07-17
DE59804785D1 (de) 2002-08-22
AU714264B2 (en) 1999-12-23
AR034226A2 (es) 2004-02-04
EP0917879A3 (de) 1999-06-09
KR100315908B1 (ko) 2002-04-24
ATE220558T1 (de) 2002-08-15
TR199802394A2 (xx) 1999-06-21
US6238664B1 (en) 2001-05-29
AR018020A1 (es) 2001-10-31
JPH11240895A (ja) 1999-09-07
CN1220270A (zh) 1999-06-23
BRPI9805021B8 (pt) 2021-07-06
PT917879E (pt) 2002-12-31
ES2179414T3 (es) 2003-01-16
DK0917879T3 (da) 2002-11-04
BRPI9805021B1 (pt) 2011-05-31

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Legal Events

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B16A Patent or certificate of addition of invention granted [chapter 16.1 patent gazette]

Free format text: PRAZO DE VALIDADE: 10 (DEZ) ANOS CONTADOS A PARTIR DE 31/05/2011, OBSERVADAS AS CONDICOES LEGAIS.

B21A Patent or certificate of addition expired [chapter 21.1 patent gazette]

Free format text: PATENTE EXTINTA EM 31.05.2021

B16C Correction of notification of the grant [chapter 16.3 patent gazette]

Free format text: PRAZO DE VALIDADE: 20 (VINTE) ANOS CONTADOS A PARTIR DE 23/11/98, OBSERVADAS AS CONDICOES LEGAIS. PATENTE CONCEDIDA CONFORME ADI 5.529/DF, QUE DETERMINA A ALTERACAO DO PRAZO DE CONCESSAO