BR112014020602B1 - Método para a fabricação de uma composição de imunoglobulina igg enriquecida - Google Patents
Método para a fabricação de uma composição de imunoglobulina igg enriquecida Download PDFInfo
- Publication number
- BR112014020602B1 BR112014020602B1 BR112014020602-3A BR112014020602A BR112014020602B1 BR 112014020602 B1 BR112014020602 B1 BR 112014020602B1 BR 112014020602 A BR112014020602 A BR 112014020602A BR 112014020602 B1 BR112014020602 B1 BR 112014020602B1
- Authority
- BR
- Brazil
- Prior art keywords
- suspension
- igg
- precipitation
- precipitate
- cohn
- Prior art date
Links
Images
Classifications
-
- 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
- A61K39/39591—Stabilisation, fragmentation
-
- 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
- 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
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P27/00—Drugs for disorders of the senses
- A61P27/02—Ophthalmic agents
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P37/00—Drugs for immunological or allergic disorders
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P37/00—Drugs for immunological or allergic disorders
- A61P37/02—Immunomodulators
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K1/00—General methods for the preparation of peptides, i.e. processes for the organic chemical preparation of peptides or proteins of any length
- C07K1/14—Extraction; Separation; Purification
- C07K1/30—Extraction; Separation; Purification by precipitation
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
- C07K16/06—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies from serum
- C07K16/065—Purification, fragmentation
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K1/00—General methods for the preparation of peptides, i.e. processes for the organic chemical preparation of peptides or proteins of any length
- C07K1/14—Extraction; Separation; Purification
- C07K1/145—Extraction; Separation; Purification by extraction or solubilisation
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Medicinal Chemistry (AREA)
- General Health & Medical Sciences (AREA)
- Organic Chemistry (AREA)
- Immunology (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- Pharmacology & Pharmacy (AREA)
- Animal Behavior & Ethology (AREA)
- Engineering & Computer Science (AREA)
- Epidemiology (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Cell Biology (AREA)
- Biochemistry (AREA)
- Hematology (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Molecular Biology (AREA)
- Genetics & Genomics (AREA)
- Biophysics (AREA)
- Microbiology (AREA)
- Mycology (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Biomedical Technology (AREA)
- Zoology (AREA)
- Analytical Chemistry (AREA)
- Virology (AREA)
- Developmental Biology & Embryology (AREA)
- Biotechnology (AREA)
- Ophthalmology & Optometry (AREA)
- Communicable Diseases (AREA)
- Rheumatology (AREA)
- Pain & Pain Management (AREA)
- Oncology (AREA)
- Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
- Peptides Or Proteins (AREA)
- Medicines Containing Material From Animals Or Micro-Organisms (AREA)
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US201261602488P | 2012-02-23 | 2012-02-23 | |
| US61/602488 | 2012-02-23 | ||
| PCT/US2013/027681 WO2013126904A1 (en) | 2012-02-23 | 2013-02-25 | Fraction i-iv-1 precipitation of immunoglobins from plasma |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| BR112014020602A2 BR112014020602A2 (pt) | 2018-09-11 |
| BR112014020602B1 true BR112014020602B1 (pt) | 2022-12-20 |
Family
ID=47833446
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| BR112014020602-3A BR112014020602B1 (pt) | 2012-02-23 | 2013-02-25 | Método para a fabricação de uma composição de imunoglobulina igg enriquecida |
Country Status (25)
| Country | Link |
|---|---|
| US (1) | US9782477B2 (enExample) |
| EP (2) | EP2817334B1 (enExample) |
| JP (1) | JP6291423B2 (enExample) |
| KR (1) | KR101930582B1 (enExample) |
| CN (1) | CN104245730B (enExample) |
| AR (1) | AR090425A1 (enExample) |
| AU (1) | AU2013203112B2 (enExample) |
| BR (1) | BR112014020602B1 (enExample) |
| CA (1) | CA2864715A1 (enExample) |
| CL (1) | CL2014002225A1 (enExample) |
| CO (1) | CO7081143A2 (enExample) |
| DK (1) | DK2817334T3 (enExample) |
| EA (1) | EA032478B1 (enExample) |
| ES (1) | ES2928954T3 (enExample) |
| HU (1) | HUE060195T2 (enExample) |
| IL (1) | IL234103B (enExample) |
| MX (2) | MX365236B (enExample) |
| MY (1) | MY167235A (enExample) |
| NZ (1) | NZ628529A (enExample) |
| PL (1) | PL2817334T3 (enExample) |
| PT (1) | PT2817334T (enExample) |
| SG (1) | SG11201405149UA (enExample) |
| SI (1) | SI2817334T1 (enExample) |
| TW (1) | TWI629283B (enExample) |
| WO (1) | WO2013126904A1 (enExample) |
Families Citing this family (14)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| AU2013203043B2 (en) | 2013-03-15 | 2016-10-06 | Takeda Pharmaceutical Company Limited | Methods to produce a human plasma-derived igg preparation enriched in brain disease-related natural iggs |
| CN104004091B (zh) * | 2014-06-12 | 2016-08-17 | 新疆德源生物工程有限公司 | 一种人免疫球蛋白的制备工艺 |
| CN104004090A (zh) * | 2014-06-12 | 2014-08-27 | 新疆德源生物工程有限公司 | 一种人免疫球蛋白的制备方法 |
| GB201413227D0 (en) | 2014-07-25 | 2014-09-10 | Bioproducts Lab Ltd | Process |
| ES2887588T3 (es) | 2015-08-13 | 2021-12-23 | Kamada Ltd | Composiciones derivadas de pasta de fracción de Cohn y uso de las mismas |
| US11040068B2 (en) * | 2017-04-26 | 2021-06-22 | Alkahest, Inc. | Dosing regimen for treatment of cognitive and motor impairments with blood plasma and blood plasma products |
| SG11202003793WA (en) | 2017-10-30 | 2020-05-28 | Baxalta GmbH | Environmentally compatible detergents for inactivation of lipid-enveloped viruses |
| EP3794013B1 (en) * | 2018-05-17 | 2024-02-21 | CSL Behring AG | Method and system of protein extraction |
| JP2023502412A (ja) * | 2019-11-20 | 2023-01-24 | ツェー・エス・エル・ベーリング・アクチエンゲゼルシャフト | 沈殿物からタンパク質を抽出する方法および不純物を沈殿させる方法 |
| JP2023526738A (ja) * | 2020-04-10 | 2023-06-23 | プラズマ テクノロジーズ エルエルシー | タンパク質の単純化した高効率単離のための組成物および方法 |
| CN116322920A (zh) * | 2020-11-09 | 2023-06-23 | 武田药品工业株式会社 | 使用氧化硅吸附从血浆中纯化fviii |
| CN112250757A (zh) * | 2020-11-13 | 2021-01-22 | 广东深蓝生物科技有限公司 | 一种猪血浆中蛋白质的提取纯化方法 |
| EP4271706A4 (en) * | 2020-12-28 | 2025-01-15 | Plasma Technologies LLC | SYSTEMS AND METHODS FOR THE ISOLATION OF IMMUNGLOBULIN G ON A PROCESS SCALE |
| CN118580342B (zh) * | 2024-05-20 | 2025-02-07 | 广东丹霞生物制药有限公司 | 一种静脉注射用人免疫球蛋白制剂的制备工艺 |
Family Cites Families (29)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| SE348942B (enExample) | 1970-06-02 | 1972-09-18 | Statens Bakteriologiska Labor | |
| US3998946A (en) | 1975-04-23 | 1976-12-21 | The Regents Of The University Of Minnesota | Fibrinogen-free plasminogen-plasmin-free plasma and method of preparing and using same |
| US4136094A (en) | 1977-08-31 | 1979-01-23 | The Regents Of The University Of Minnesota | Preparation of intravenous human and animal gamma globulins and isolation of albumin |
| US4499073A (en) | 1981-08-24 | 1985-02-12 | Cutter Laboratories, Inc. | Intravenously injectable immune serum globulin |
| JPS5855432A (ja) * | 1981-09-29 | 1983-04-01 | Fujirebio Inc | 静脈注射用免疫グロブリンの製法 |
| DK166763C (da) | 1983-03-16 | 1993-07-12 | Immuno Ag | Immunoglobulin-g-holdig fraktion |
| US5177194A (en) | 1990-02-01 | 1993-01-05 | Baxter International, Inc. | Process for purifying immune serum globulins |
| FR2706466B1 (fr) | 1993-06-14 | 1995-08-25 | Aetsrn | Concentré d'immunoglobulines G à usage thérapeutique et procédé de production dudit concentré. |
| US6284874B1 (en) | 1994-06-17 | 2001-09-04 | Alpha Therapeutic Corporation | Process for separating α1-proteinase inhibitor from cohn fraction IV1 and IV4 paste |
| US5616693A (en) | 1996-07-01 | 1997-04-01 | Alpha Therapeutic Corporation | Process for seperating alpha-1-proteinase inhibitor from COHN IV1 +1V4 paste |
| TW491855B (en) | 1996-08-07 | 2002-06-21 | Csl Ltd | Purification of immunoglobulins |
| CA2232420A1 (en) | 1997-03-19 | 1998-09-19 | The Green Cross Corporation | Immunoglobulin preparation and preparation process thereof |
| GB9705810D0 (en) * | 1997-03-20 | 1997-05-07 | Common Services Agency | Intravenous immune globulin |
| US5886154A (en) | 1997-06-20 | 1999-03-23 | Lebing; Wytold R. | Chromatographic method for high yield purification and viral inactivation of antibodies |
| CN1520885A (zh) | 1997-10-23 | 2004-08-18 | ������ҩ��ʽ���� | 可室温贮存的免疫球蛋白静脉注射制剂 |
| SE0001128D0 (sv) | 2000-03-30 | 2000-03-30 | Amersham Pharm Biotech Ab | A method of producing IgG |
| FR2824568B1 (fr) | 2001-05-11 | 2004-04-09 | Lab Francais Du Fractionnement | Procede de preparation de concentres d'immunoglobulines humaines a usage therapeutique |
| JPWO2003004982A1 (ja) * | 2001-07-05 | 2004-10-28 | 浜松ホトニクス株式会社 | 分光装置 |
| US6893639B2 (en) * | 2001-10-19 | 2005-05-17 | Hemacare Corporation | Method for high yield purification of immune globulins from blood plasma and blood plasma intermediates |
| SI1664123T2 (sl) | 2003-09-22 | 2012-03-30 | Kamada Ltd | Priprava inhibitorja alfa proteinaze v velikem merilu in njegova uporaba |
| JP2008500959A (ja) | 2004-01-30 | 2008-01-17 | スオメン プナイネン リスティ ヴェリパルヴェル | ウイルスについて安全な免疫グロブリンの製造方法 |
| EP1718675B2 (en) | 2004-02-27 | 2017-01-25 | Octapharma AG | A method of providing a purified, virus safe antibody preparation |
| US7807435B2 (en) | 2005-08-11 | 2010-10-05 | Baxter International Inc. | Method for the purification of alpha-1 proteinase inhibitor (a1PI) |
| EP2129686B1 (en) | 2007-03-20 | 2016-07-13 | CSL Behring GmbH | Methods for industrial scale production of therapeutic complement factor h preparations from human plasma |
| JP5341252B2 (ja) * | 2009-05-27 | 2013-11-13 | バクスター・インターナショナル・インコーポレイテッド | 皮下使用の高濃度免疫グロブリン製剤を生成する方法 |
| AT514675B1 (de) * | 2009-07-23 | 2019-05-15 | Baxalta Inc | Herstellung von faktor h (fh) und fh-derivaten aus plasma |
| WO2011150284A2 (en) * | 2010-05-26 | 2011-12-01 | Baxter International Inc. | Removal of serine proteases by treatment with finely divided silicon dioxide |
| AU2010202125B1 (en) * | 2010-05-26 | 2010-09-02 | Takeda Pharmaceutical Company Limited | A method to produce an immunoglobulin preparation with improved yield |
| BR112013001753A2 (pt) | 2010-07-23 | 2016-05-31 | Baxter Healthcare Sa | método para preparar uma composição d einter-alfa-inibidor (iaip) eriquecida de plasma, solução aquosa de iaip, e, método para tratar uma doença ou distúrbio associado com disfunção de iaip e associado com atividadede protease de serina no plasma aumentada. |
-
2013
- 2013-02-23 TW TW102106384A patent/TWI629283B/zh active
- 2013-02-25 WO PCT/US2013/027681 patent/WO2013126904A1/en not_active Ceased
- 2013-02-25 AU AU2013203112A patent/AU2013203112B2/en active Active
- 2013-02-25 EA EA201491564A patent/EA032478B1/ru not_active IP Right Cessation
- 2013-02-25 ES ES13708051T patent/ES2928954T3/es active Active
- 2013-02-25 EP EP13708051.1A patent/EP2817334B1/en active Active
- 2013-02-25 CN CN201380020621.XA patent/CN104245730B/zh active Active
- 2013-02-25 MY MYPI2014002439A patent/MY167235A/en unknown
- 2013-02-25 PL PL13708051.1T patent/PL2817334T3/pl unknown
- 2013-02-25 DK DK13708051.1T patent/DK2817334T3/da active
- 2013-02-25 US US13/776,448 patent/US9782477B2/en active Active
- 2013-02-25 MX MX2014010076A patent/MX365236B/es active IP Right Grant
- 2013-02-25 SI SI201332012T patent/SI2817334T1/sl unknown
- 2013-02-25 EP EP22191464.1A patent/EP4119574A1/en active Pending
- 2013-02-25 BR BR112014020602-3A patent/BR112014020602B1/pt active IP Right Grant
- 2013-02-25 SG SG11201405149UA patent/SG11201405149UA/en unknown
- 2013-02-25 CA CA2864715A patent/CA2864715A1/en not_active Abandoned
- 2013-02-25 KR KR1020147026210A patent/KR101930582B1/ko active Active
- 2013-02-25 NZ NZ628529A patent/NZ628529A/en unknown
- 2013-02-25 AR ARP130100566A patent/AR090425A1/es not_active Application Discontinuation
- 2013-02-25 HU HUE13708051A patent/HUE060195T2/hu unknown
- 2013-02-25 JP JP2014558931A patent/JP6291423B2/ja active Active
- 2013-02-25 PT PT137080511T patent/PT2817334T/pt unknown
-
2014
- 2014-08-13 IL IL23410314A patent/IL234103B/en active IP Right Grant
- 2014-08-21 MX MX2019005999A patent/MX2019005999A/es unknown
- 2014-08-21 CL CL2014002225A patent/CL2014002225A1/es unknown
- 2014-09-23 CO CO14210313A patent/CO7081143A2/es unknown
Also Published As
Similar Documents
| Publication | Publication Date | Title |
|---|---|---|
| BR112014020602B1 (pt) | Método para a fabricação de uma composição de imunoglobulina igg enriquecida | |
| ES2536093T3 (es) | Procedimiento para preparar una composición de IgG enriquecida a partir de plasma | |
| JP2013535468A (ja) | 血漿由来インターα阻害タンパク質（ＩａＩｐ）の製造方法 | |
| ES2624485T3 (es) | Método para reducir el potencial tromboembólico de una composición de inmunoglobulinas derivada de plasma | |
| JP7717715B2 (ja) | Ｃ－１インヒビター欠乏血漿から免疫グロブリン製剤を生産する方法 | |
| HK40086420A (en) | Fraction i-iv-1 precipitation of immunoglobins from plasma | |
| HK1205520B (en) | Fraction i-iv-1 precipitation of immunoglobins from plasma |
Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| B06F | Objections, documents and/or translations needed after an examination request according [chapter 6.6 patent gazette] | ||
| B25A | Requested transfer of rights approved |
Owner name: BAXALTA GMBH (CH) ; BAXALTA INCORPORATED (US) |
|
| B08F | Application dismissed because of non-payment of annual fees [chapter 8.6 patent gazette] |
Free format text: REFERENTE A 6A ANUIDADE. |
|
| B08G | Application fees: restoration [chapter 8.7 patent gazette] | ||
| B07D | Technical examination (opinion) related to article 229 of industrial property law [chapter 7.4 patent gazette] |
Free format text: DE ACORDO COM O ARTIGO 229-C DA LEI NAO 10196/2001, QUE MODIFICOU A LEI NAO 9279/96, A CONCESSAO DA PATENTE ESTA CONDICIONADA A ANUAANCIA PRA VIA DA ANVISA. CONSIDERANDO A APROVAA AO DOS TERMOS DO PARECER NAO 337/PGF/EA/2010, BEM COMO A PORTARIA INTERMINISTERIAL NAO 1065 DE 24/05/2012, ENCAMINHA-SE O PRESENTE PEDIDO PARA AS PROVIDAANCIAS CABA-VEIS. |
|
| B07G | Grant request does not fulfill article 229-c lpi (prior consent of anvisa) [chapter 7.7 patent gazette] |
Free format text: NOTIFICACAO DE DEVOLUCAO DO PEDIDO EM FUNCAO DA REVOGACAO DO ART. 229-C DA LEI NO 9.279, DE 1996, POR FORCA DA LEI NO 14.195, DE 2021 |
|
| B06U | Preliminary requirement: requests with searches performed by other patent offices: procedure suspended [chapter 6.21 patent gazette] | ||
| B25A | Requested transfer of rights approved |
Owner name: TAKEDA PHARMACEUTICAL COMPANY LIMITED (JP) |
|
| B09A | Decision: intention to grant [chapter 9.1 patent gazette] | ||
| B16A | Patent or certificate of addition of invention granted [chapter 16.1 patent gazette] |
Free format text: PRAZO DE VALIDADE: 20 (VINTE) ANOS CONTADOS A PARTIR DE 25/02/2013, OBSERVADAS AS CONDICOES LEGAIS |