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
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)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- Animal Behavior & Ethology (AREA)
- Pharmacology & Pharmacy (AREA)
- Epidemiology (AREA)
- Organic Chemistry (AREA)
- Genetics & Genomics (AREA)
- Wood Science & Technology (AREA)
- Zoology (AREA)
- Microbiology (AREA)
- Biotechnology (AREA)
- General Engineering & Computer Science (AREA)
- Biochemistry (AREA)
- Biomedical Technology (AREA)
- Molecular Biology (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
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.
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 (20)
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 |
US8632785B2 (en) * | 2000-02-08 | 2014-01-21 | Allergan, Inc. | Clostridial toxin pharmaceutical composition containing a gelatin fragment |
US20030118598A1 (en) * | 2000-02-08 | 2003-06-26 | Allergan, Inc. | Clostridial toxin pharmaceutical compositions |
DE60125986T3 (de) * | 2000-02-08 | 2011-07-28 | Allergan, Inc., 92612, Calif. | Pharmazeutische Zusammensetzungen mit Botulinum Toxin |
US7780967B2 (en) | 2000-02-08 | 2010-08-24 | Allergan, Inc. | Reduced toxicity Clostridial toxin pharmaceutical compositions |
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 |
US8765124B2 (en) * | 2003-02-28 | 2014-07-01 | Chugai Seiyaku Kabushiki Kaisha | Stabilized preparation containing protein |
US20070190047A1 (en) * | 2005-07-29 | 2007-08-16 | Amgen, Inc. | Formulations that inhibit protein aggregation |
CN101522219A (zh) * | 2006-10-12 | 2009-09-02 | 惠氏公司 | 改变抗体溶液中离子强度以减少乳光/聚集物 |
KR20120027031A (ko) * | 2009-06-18 | 2012-03-20 | 와이어쓰 엘엘씨 | 소형 모듈 면역제약용 동결건조 제제 |
RS60226B1 (sr) | 2012-09-07 | 2020-06-30 | Coherus Biosciences Inc | Stabilne vodene formulacije adalimumaba |
AU2015339886B2 (en) * | 2014-09-29 | 2019-05-09 | 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 |
US11071782B2 (en) | 2016-04-20 | 2021-07-27 | Coherus Biosciences, Inc. | 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)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
DE3064888D1 (en) | 1979-04-30 | 1983-10-27 | Hoechst Ag | Aqueous solutions of proteins stable against denaturization, process for their manufacture, and their utilization |
US4783441A (en) | 1979-04-30 | 1988-11-08 | Hoechst Aktiengesellschaft | Aqueous protein solutions stable to denaturation |
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 |
DE3863908D1 (de) | 1987-11-27 | 1991-08-29 | 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 |
-
1998
- 1998-11-13 PT PT98121684T patent/PT917879E/pt unknown
- 1998-11-13 EP EP98121684A patent/EP0917879B1/de not_active Revoked
- 1998-11-13 AT AT98121684T patent/ATE220558T1/de not_active IP Right Cessation
- 1998-11-13 DE DE59804785T patent/DE59804785D1/de not_active Revoked
- 1998-11-13 ES ES98121684T patent/ES2179414T3/es not_active Expired - Lifetime
- 1998-11-13 DK DK98121684T patent/DK0917879T3/da active
- 1998-11-19 US US09/196,090 patent/US6238664B1/en not_active Expired - Lifetime
- 1998-11-20 CA CA002254145A patent/CA2254145C/en not_active Expired - Lifetime
- 1998-11-20 ZA ZA9810650A patent/ZA9810650B/xx unknown
- 1998-11-20 AU AU94060/98A patent/AU714264B2/en not_active Expired
- 1998-11-20 KR KR1019980049921A patent/KR100315908B1/ko not_active IP Right Cessation
- 1998-11-20 AR ARP980105921A patent/AR018020A1/es unknown
- 1998-11-20 TR TR1998/02394A patent/TR199802394A2/xx unknown
- 1998-11-20 CN CN98122531A patent/CN1220270A/zh active Pending
- 1998-11-23 BR BRPI9805021-4 patent/BRPI9805021B8/pt not_active IP Right Cessation
- 1998-11-24 JP JP10332681A patent/JP3105494B2/ja not_active Expired - Lifetime
-
2002
- 2002-05-09 AR ARP020101691A patent/AR034226A2/es not_active Application Discontinuation
Also Published As
Publication number | Publication date |
---|---|
JPH11240895A (ja) | 1999-09-07 |
AR018020A1 (es) | 2001-10-31 |
KR19990045460A (ko) | 1999-06-25 |
TR199802394A3 (tr) | 1999-06-21 |
PT917879E (pt) | 2002-12-31 |
TR199802394A2 (xx) | 1999-06-21 |
EP0917879A3 (de) | 1999-06-09 |
BRPI9805021A (pt) | 2000-03-21 |
DE59804785D1 (de) | 2002-08-22 |
EP0917879B1 (de) | 2002-07-17 |
AU9406098A (en) | 1999-06-10 |
ES2179414T3 (es) | 2003-01-16 |
BRPI9805021B1 (pt) | 2011-05-31 |
CA2254145A1 (en) | 1999-05-22 |
CA2254145C (en) | 2002-10-08 |
DK0917879T3 (da) | 2002-11-04 |
CN1220270A (zh) | 1999-06-23 |
US6238664B1 (en) | 2001-05-29 |
ATE220558T1 (de) | 2002-08-15 |
ZA9810650B (en) | 1999-05-24 |
JP3105494B2 (ja) | 2000-10-30 |
KR100315908B1 (ko) | 2002-04-24 |
AU714264B2 (en) | 1999-12-23 |
EP0917879A2 (de) | 1999-05-26 |
BRPI9805021B8 (pt) | 2021-07-06 |
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Legal Events
Date | Code | Title | Description |
---|---|---|---|
FC | Refusal |