BR112014004828A2 - método para preparação de uma composição compreendendo anticorpos altamente concentrados por ultrafiltração - Google Patents
método para preparação de uma composição compreendendo anticorpos altamente concentrados por ultrafiltraçãoInfo
- Publication number
- BR112014004828A2 BR112014004828A2 BR112014004828A BR112014004828A BR112014004828A2 BR 112014004828 A2 BR112014004828 A2 BR 112014004828A2 BR 112014004828 A BR112014004828 A BR 112014004828A BR 112014004828 A BR112014004828 A BR 112014004828A BR 112014004828 A2 BR112014004828 A2 BR 112014004828A2
- Authority
- BR
- Brazil
- Prior art keywords
- preparing
- composition
- highly concentrated
- antibodies
- ultrafiltration
- Prior art date
Links
Classifications
-
- 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
- C07K1/34—Extraction; Separation; Purification by filtration, ultrafiltration or reverse osmosis
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
- B01D—SEPARATION
- B01D61/00—Processes of separation using semi-permeable membranes, e.g. dialysis, osmosis or ultrafiltration; Apparatus, accessories or auxiliary operations specially adapted therefor
- B01D61/14—Ultrafiltration; Microfiltration
- B01D61/145—Ultrafiltration
-
- 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
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
- B01D—SEPARATION
- B01D2311/00—Details relating to membrane separation process operations and control
- B01D2311/14—Pressure control
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
- B01D—SEPARATION
- B01D2311/00—Details relating to membrane separation process operations and control
- B01D2311/16—Flow or flux control
- B01D2311/165—Cross-flow velocity control
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
- B01D—SEPARATION
- B01D2315/00—Details relating to the membrane module operation
- B01D2315/14—Batch-systems
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
- B01D—SEPARATION
- B01D2321/00—Details relating to membrane cleaning, regeneration, sterilization or to the prevention of fouling
- B01D2321/02—Forward flushing
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
- B01D—SEPARATION
- B01D61/00—Processes of separation using semi-permeable membranes, e.g. dialysis, osmosis or ultrafiltration; Apparatus, accessories or auxiliary operations specially adapted therefor
- B01D61/14—Ultrafiltration; Microfiltration
- B01D61/22—Controlling or regulating
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
- C07K16/18—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
- C07K16/28—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
- C07K16/2866—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against receptors for cytokines, lymphokines, interferons
Landscapes
- Chemical & Material Sciences (AREA)
- Health & Medical Sciences (AREA)
- Engineering & Computer Science (AREA)
- Water Supply & Treatment (AREA)
- Organic Chemistry (AREA)
- Medicinal Chemistry (AREA)
- Life Sciences & Earth Sciences (AREA)
- General Health & Medical Sciences (AREA)
- Immunology (AREA)
- Genetics & Genomics (AREA)
- Molecular Biology (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Biophysics (AREA)
- Biochemistry (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Analytical Chemistry (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Microbiology (AREA)
- Mycology (AREA)
- Pharmacology & Pharmacy (AREA)
- Epidemiology (AREA)
- Animal Behavior & Ethology (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Peptides Or Proteins (AREA)
- Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
- Separation Using Semi-Permeable Membranes (AREA)
- Preparation Of Compounds By Using Micro-Organisms (AREA)
Abstract
resumo patente de invenção: "método para preparação de uma composição compreendendo anticorpos altamente concentrados por ultrafiltração". a presente invenção refere-se a um método para preparação de uma composição compreendendo anticorpos altamente concentrados pela ultrafiltração em modo de concentração em batelada tendo uma primeira taxa de alimentação constante e uma segunda taxa de alimentação controlada.
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US201161530158P | 2011-09-01 | 2011-09-01 | |
US61/530,158 | 2011-09-01 | ||
PCT/JP2012/005536 WO2013031237A1 (en) | 2011-09-01 | 2012-08-31 | Method for preparing a composition comprising highly concentrated antibodies by ultrafiltration |
Publications (3)
Publication Number | Publication Date |
---|---|
BR112014004828A2 true BR112014004828A2 (pt) | 2017-04-04 |
BR112014004828B1 BR112014004828B1 (pt) | 2021-03-09 |
BR112014004828B8 BR112014004828B8 (pt) | 2022-03-29 |
Family
ID=46982845
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
BR112014004828A BR112014004828B8 (pt) | 2011-09-01 | 2012-08-31 | Métodos para preparação de composições compreendendo anticorpos ou proteínas concentradas por ultrafiltração |
Country Status (15)
Country | Link |
---|---|
US (3) | US9630988B2 (pt) |
EP (2) | EP2750784A1 (pt) |
JP (2) | JP6363017B2 (pt) |
KR (1) | KR101993488B1 (pt) |
CN (1) | CN103889555B (pt) |
AU (2) | AU2012303372A1 (pt) |
BR (1) | BR112014004828B8 (pt) |
CA (1) | CA2847302C (pt) |
IL (1) | IL231128B (pt) |
MX (1) | MX359235B (pt) |
MY (1) | MY182178A (pt) |
RU (1) | RU2638859C9 (pt) |
SG (1) | SG11201400260TA (pt) |
WO (1) | WO2013031237A1 (pt) |
ZA (1) | ZA201401184B (pt) |
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EP2011514B1 (en) | 1997-03-21 | 2012-02-29 | Chugai Seiyaku Kabushiki Kaisha | A preventive or therapeutic agent for sensitized T cell-mediated diseases comprising IL-6 antagonist as an active ingredient |
UA80091C2 (en) | 2001-04-02 | 2007-08-27 | Chugai Pharmaceutical Co Ltd | Remedies for infant chronic arthritis-relating diseases and still's disease which contain an interleukin-6 (il-6) antagonist |
GB2401040A (en) | 2003-04-28 | 2004-11-03 | Chugai Pharmaceutical Co Ltd | Method for treating interleukin-6 related diseases |
PE20091174A1 (es) | 2007-12-27 | 2009-08-03 | Chugai Pharmaceutical Co Ltd | Formulacion liquida con contenido de alta concentracion de anticuerpo |
CN102596995B (zh) | 2009-10-26 | 2015-08-12 | 弗·哈夫曼-拉罗切有限公司 | 用于生产糖基化免疫球蛋白的方法 |
KR20190120439A (ko) | 2010-11-08 | 2019-10-23 | 제넨테크, 인크. | 피하 투여용 항―il―6 수용체 항체 |
JP6062433B2 (ja) * | 2011-08-03 | 2017-01-18 | プロラクタ バイオサイエンス,インコーポレイテッド | 細菌汚染を低減するためのヒト乳の精密濾過 |
KR102248581B1 (ko) | 2013-07-04 | 2021-05-06 | 에프. 호프만-라 로슈 아게 | 혈청 샘플 중 항-약물 항체를 검출하기 위한 간섭-억제된 면역분석 |
WO2016067177A1 (en) | 2014-10-27 | 2016-05-06 | Tmci Padovan S.P.A. | Improved filtration plant and relative method |
CN104673666A (zh) * | 2015-03-10 | 2015-06-03 | 华东理工大学 | 一种微型切向流过滤模拟装置 |
GB201600287D0 (en) * | 2016-01-07 | 2016-02-24 | Fujifilm Diosynth Biotechnologies Uk Ltd | Process |
IL264907B2 (en) | 2016-09-15 | 2023-03-01 | Evoqua Water Tech Llc | Method and system for treating ultra-purified water |
JP6399723B1 (ja) * | 2018-02-21 | 2018-10-03 | 株式会社グロータック | 自転車用変速操作装置 |
SG11202100391VA (en) | 2018-07-27 | 2021-02-25 | Arc Medical Devices Inc | Highly sulfated fucans for the treatment of fibrous adhesions |
KR20210044821A (ko) * | 2018-08-14 | 2021-04-23 | 브리스톨-마이어스 스큅 컴퍼니 | 개선된 단백질 회수 |
DE102019101745A1 (de) * | 2019-01-24 | 2020-07-30 | Putsch Gmbh & Co. Kg | Verfahren zum Betrieb einer Membranfilteranlage |
US20220226779A1 (en) * | 2019-03-05 | 2022-07-21 | Arc Medical Devices Inc. | Systems and methods for tangential flow filtration of viscous compositions |
CN111018968B (zh) * | 2019-12-16 | 2021-07-27 | 兴盟生物医药(苏州)有限公司 | 一种通过超滤浓缩制备高浓度抗体制剂的方法 |
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EP0408046B1 (en) | 1989-07-14 | 1995-10-25 | The Dow Chemical Company | Isotropic or anisotropic microporous syndiotactic polystyrene membranes and processes for preparation |
JPH0380921A (ja) * | 1989-08-24 | 1991-04-05 | Shinko Pantec Co Ltd | 膜濾過装置の運転方法 |
JPH0778025B2 (ja) | 1990-03-20 | 1995-08-23 | 日本赤十字社 | 免疫グロブリンgの製造方法 |
ES2134212T3 (es) | 1991-04-25 | 1999-10-01 | Chugai Pharmaceutical Co Ltd | Anticuerpo humano reconstituido contra el receptor de la interleuquina 6 humano. |
JP3091885B2 (ja) | 1991-07-05 | 2000-09-25 | 株式会社日立製作所 | 高温型二次電池及び電池モジュール |
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UA76934C2 (en) | 1996-10-04 | 2006-10-16 | Chugai Pharmaceutical Co Ltd | Reconstructed human anti-hm 1.24 antibody, coding dna, vector, host cell, method for production of reconstructed human antibody, pharmaceutical composition and drug for treating myeloma containing reconstructed human anti-hm 1.24 antibody |
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BR9909382A (pt) | 1998-04-03 | 2000-12-05 | Chugai Pharmaceutical Co Ltd | Anticorpo humanizado contra o fator tissular humano (tf) e processo de produção de anticorpo humanizado |
DE19827473C1 (de) * | 1998-06-19 | 1999-08-26 | Sartorius Gmbh | Verbesserte Crossflow-Filterkassetten |
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AU2003251592A1 (en) * | 2002-06-21 | 2004-01-06 | Biogen Idec Inc. | Buffered formulations for concentrating antibodies and methods of use thereof |
US20040167320A1 (en) | 2003-02-24 | 2004-08-26 | Couto Daniel E. | Methods of tangential flow filtration and an apparatus therefore |
AU2004256354B2 (en) | 2003-07-15 | 2011-07-07 | Chugai Seiyaku Kabushiki Kaisha | IgM production by transformed cells and methods for quantifying said IgM production |
ATE491350T1 (de) | 2004-02-18 | 2011-01-15 | Bucher Unipektin Ag | Verfahren zur diafiltration eines produktes und vorrichtung zur durchfuhrung des verfahrens |
US7410587B2 (en) * | 2004-08-03 | 2008-08-12 | Scilog, Inc. | Liquid handling for filtration and preparative chromatography |
US20060051347A1 (en) | 2004-09-09 | 2006-03-09 | Winter Charles M | Process for concentration of antibodies and therapeutic products thereof |
DOP2006000029A (es) * | 2005-02-07 | 2006-08-15 | Genentech Inc | Antibody variants and uses thereof. (variantes de un anticuerpo y usos de las mismas) |
US8741600B2 (en) | 2007-06-19 | 2014-06-03 | Asahi Kasei Kabushiki Kaisha | Method for separation of immunoglobulin monomers |
WO2008156124A1 (ja) | 2007-06-19 | 2008-12-24 | Asahi Kasei Kabushiki Kaisha | 免疫グロブリン1量体の分離方法 |
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-
2012
- 2012-08-31 CN CN201280053636.1A patent/CN103889555B/zh active Active
- 2012-08-31 RU RU2014112230A patent/RU2638859C9/ru active
- 2012-08-31 SG SG11201400260TA patent/SG11201400260TA/en unknown
- 2012-08-31 EP EP12769502.1A patent/EP2750784A1/en not_active Ceased
- 2012-08-31 KR KR1020147008464A patent/KR101993488B1/ko active IP Right Grant
- 2012-08-31 BR BR112014004828A patent/BR112014004828B8/pt active IP Right Grant
- 2012-08-31 WO PCT/JP2012/005536 patent/WO2013031237A1/en active Application Filing
- 2012-08-31 CA CA2847302A patent/CA2847302C/en active Active
- 2012-08-31 US US14/241,567 patent/US9630988B2/en active Active
- 2012-08-31 EP EP17170961.1A patent/EP3235557A1/en active Pending
- 2012-08-31 MX MX2014002253A patent/MX359235B/es active IP Right Grant
- 2012-08-31 MY MYPI2014700440A patent/MY182178A/en unknown
- 2012-08-31 JP JP2014510575A patent/JP6363017B2/ja active Active
- 2012-08-31 AU AU2012303372A patent/AU2012303372A1/en not_active Abandoned
-
2014
- 2014-02-17 ZA ZA2014/01184A patent/ZA201401184B/en unknown
- 2014-02-24 IL IL231128A patent/IL231128B/en active IP Right Grant
-
2017
- 2017-03-06 JP JP2017041820A patent/JP6363751B2/ja active Active
- 2017-03-17 US US15/461,874 patent/US10590164B2/en active Active
- 2017-06-28 AU AU2017204395A patent/AU2017204395B2/en active Active
-
2020
- 2020-02-05 US US16/782,493 patent/US20200172569A1/en active Pending
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Legal Events
Date | Code | Title | Description |
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B06F | Objections, documents and/or translations needed after an examination request according [chapter 6.6 patent gazette] | ||
B06U | Preliminary requirement: requests with searches performed by other patent offices: procedure suspended [chapter 6.21 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 NO 10196/2001, QUE MODIFICOU A LEI NO 9279/96, A CONCESSAO DA PATENTE ESTA CONDICIONADA A ANUENCIA PREVIA DA ANVISA. CONSIDERANDO A APROVACAO DOS TERMOS DO PARECER NO 337/PGF/EA/2010, BEM COMO A PORTARIA INTERMINISTERIAL NO 1065 DE 24/05/2012, ENCAMINHA-SE O PRESENTE PEDIDO PARA AS PROVIDENCIAS CABIVEIS. |
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B07E | Notification of approval relating to section 229 industrial property law [chapter 7.5 patent gazette] | ||
B07A | Application suspended after technical examination (opinion) [chapter 7.1 patent gazette] | ||
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 31/08/2012, OBSERVADAS AS CONDICOES LEGAIS. |
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B16C | Correction of notification of the grant [chapter 16.3 patent gazette] |
Free format text: REF. RPI 2618 DE 09/03/2021 QUANTO AO TITULO. |