BR112014004828B8 - Métodos para preparação de composições compreendendo anticorpos ou proteínas concentradas por ultrafiltração - Google Patents
Métodos para preparação de composições compreendendo anticorpos ou proteínas concentradas por ultrafiltraçãoInfo
- Publication number
- BR112014004828B8 BR112014004828B8 BR112014004828A BR112014004828A BR112014004828B8 BR 112014004828 B8 BR112014004828 B8 BR 112014004828B8 BR 112014004828 A BR112014004828 A BR 112014004828A BR 112014004828 A BR112014004828 A BR 112014004828A BR 112014004828 B8 BR112014004828 B8 BR 112014004828B8
- Authority
- BR
- Brazil
- Prior art keywords
- ultrafiltration
- antibodies
- methods
- preparing compositions
- proteins concentrated
- 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
-
- 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
- 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
-
- 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
-
- 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
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)
- Animal Behavior & Ethology (AREA)
- Microbiology (AREA)
- Mycology (AREA)
- Pharmacology & Pharmacy (AREA)
- Epidemiology (AREA)
- Bioinformatics & Cheminformatics (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
composições líquidas compreendendo anticorpos altamente concentrados por ultrafiltração e seu método de preparação. a presente invenção se referee 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. a invenção se refere, ainda, a composições obtidas pelo referido método.
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 BR112014004828A2 (pt) | 2017-04-04 |
| BR112014004828B1 BR112014004828B1 (pt) | 2021-03-09 |
| BR112014004828B8 true 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) | EP3235557A1 (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) |
Families Citing this family (18)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| ES2312184T3 (es) | 1997-03-21 | 2009-02-16 | Chugai Seiyaku Kabushiki Kaisha | Agentes preventivos terapeuticos para el tratamiento de esclerosis multiple, que contienen anticuerpos anti-receptores de il-6 antagonistas. |
| 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 |
| JP5711751B2 (ja) | 2009-10-26 | 2015-05-07 | エフ．ホフマン−ラ ロシュ アーゲーＦ． Ｈｏｆｆｍａｎｎ−Ｌａ Ｒｏｃｈｅ Ａｋｔｉｅｎｇｅｓｅｌｌｓｃｈａｆｔ | グリコシル化された免疫グロブリンの調製方法 |
| MX2013005024A (es) | 2010-11-08 | 2013-11-21 | Chugai Pharmaceutical Co Ltd | Anticuerpo anti-il-6 receptor administrado subcutaneamente. |
| EP2739157B1 (en) * | 2011-08-03 | 2017-10-04 | Prolacta Bioscience, Inc. | Microfiltration of human milk to reduce bacterial contamination |
| CA2913687C (en) | 2013-07-04 | 2022-12-13 | F. Hoffmann-La Roche Ag | Interference-suppressed immunoassay to detect anti-drug antibodies in serum samples |
| 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 |
| WO2018053253A1 (en) * | 2016-09-15 | 2018-03-22 | Evoqua Water Technologies Llc | Method and system for treating ultrapure 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 |
| WO2020019080A1 (en) | 2018-07-27 | 2020-01-30 | Arc Medical Devices Inc. | Highly purified and/or modified fucan compositions for the treatment of fibrous adhesions |
| US20210171573A1 (en) * | 2018-08-14 | 2021-06-10 | Bristol-Myers Squibb Company | Improved protein recovery |
| DE102019101745A1 (de) * | 2019-01-24 | 2020-07-30 | Putsch Gmbh & Co. Kg | Verfahren zum Betrieb einer Membranfilteranlage |
| MX2021000866A (es) * | 2019-03-05 | 2021-06-15 | Arc Medical Devices Inc | Sistemas y metodos para la filtracion de flujo tangencial de composiciones viscosas. |
| 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 |
Family Cites Families (34)
| Publication number | Priority date | Publication date | Assignee | Title |
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| JPS6443305A (en) * | 1987-08-10 | 1989-02-15 | Fuji Photo Film Co Ltd | Cross flow type filtration process |
| KR910002501A (ko) * | 1989-07-14 | 1991-02-25 | 리차드 지. 워터맨 | 동방성 또는 이방성 미소다공성 신디오택틱 폴리스티렌 막 및 이의 제조방법 |
| 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 |
| AU668349B2 (en) | 1991-04-25 | 1996-05-02 | Chugai Seiyaku Kabushiki Kaisha | Reconstituted human antibody against human interleukin 6 receptor |
| 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 |
| AU744146B2 (en) | 1996-09-26 | 2002-02-14 | Chugai Seiyaku Kabushiki Kaisha | Antibody against human parathormone related peptides |
| 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 |
| AU735695B2 (en) * | 1996-10-10 | 2001-07-12 | Neose Technologies, Inc. | Carbohydrate purification using ultrafiltration, reverse osmosis and nanofiltration |
| CH692479A5 (de) * | 1997-07-08 | 2002-07-15 | Bucher Guyer Ag | Querstrom-Filtrationsanlage sowie Verfahren zum Betrieb einer solchen Anlage. |
| US6096872A (en) * | 1997-10-14 | 2000-08-01 | Ortho Diagnostic Systems, Inc. | Viral clearance process |
| JP3998419B2 (ja) | 1998-04-03 | 2007-10-24 | 中外製薬株式会社 | ヒト組織因子（ｔｆ）に対するヒト型化抗体およびヒト型化抗体の作製方法 |
| DE19827473C1 (de) * | 1998-06-19 | 1999-08-26 | Sartorius Gmbh | Verbesserte Crossflow-Filterkassetten |
| TWI242043B (en) | 2000-03-10 | 2005-10-21 | Chugai Pharmaceutical Co Ltd | Polypeptide inducing apoptosis |
| US6350382B1 (en) * | 2000-06-23 | 2002-02-26 | Scilog, Inc. | Enhancing filtration yields in tangential flow filtration |
| ES2332402T5 (es) | 2000-10-12 | 2018-05-14 | Genentech, Inc. | Formulaciones de proteína concentradas de viscosidad reducida |
| AU2002210917B2 (en) | 2000-10-20 | 2006-05-18 | Chugai Seiyaku Kabushiki Kaisha | Degraded TPO agonist antibody |
| WO2002092802A1 (en) * | 2001-05-14 | 2002-11-21 | Diversa Corporation | Novel methods of enzyme purification |
| EP1551875A4 (en) * | 2002-06-21 | 2006-06-28 | Biogen Idec Inc | TAMPON PREPARATIONS FOR CONCENTRATING ANTIBODIES AND METHODS FOR USE THEREOF |
| JP2006515227A (ja) | 2003-02-24 | 2006-05-25 | ジーティーシー バイオセラピューティックス インコーポレイテッド | 十字流濾過の方法およびそのための装置 |
| JP5452835B2 (ja) | 2003-07-15 | 2014-03-26 | 中外製薬株式会社 | 形質転換細胞によるＩｇＭの産生とその定量方法 |
| WO2005077208A1 (de) | 2004-02-18 | 2005-08-25 | Bucher Guyer Ag | Verfahren zur diafiltration eines produktes und vorrichtung zur durchführung 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 |
| JP5099930B2 (ja) * | 2007-06-19 | 2012-12-19 | 旭化成株式会社 | 免疫グロブリン１量体の分離方法 |
| ES2834741T3 (es) | 2007-12-05 | 2021-06-18 | Chugai Pharmaceutical Co Ltd | Anticuerpo anti-NR10 y uso del mismo |
| PE20091174A1 (es) | 2007-12-27 | 2009-08-03 | Chugai Pharmaceutical Co Ltd | Formulacion liquida con contenido de alta concentracion de anticuerpo |
| NZ589297A (en) * | 2008-05-15 | 2011-12-22 | Health L P W | Process for producing milk fractions rich in secretory immunoglobulins |
| JP2010047527A (ja) * | 2008-08-22 | 2010-03-04 | Asahi Kasei Corp | 免疫グロブリン１量体の分離方法 |
| US9586180B2 (en) * | 2009-03-24 | 2017-03-07 | Wyeth Llc | Membrane evaporation for generating highly concentrated protein therapeutics |
| JP2010248092A (ja) * | 2009-04-13 | 2010-11-04 | Asahi Kasei Corp | 免疫グロブリン１量体の分離方法 |
| AR080428A1 (es) | 2010-01-20 | 2012-04-11 | Chugai Pharmaceutical Co Ltd | Formulaciones liquidas estabilizadas contentivas de anticuerpos |
-
2012
- 2012-08-31 KR KR1020147008464A patent/KR101993488B1/ko active IP Right Grant
- 2012-08-31 EP EP17170961.1A patent/EP3235557A1/en active Pending
- 2012-08-31 CA CA2847302A patent/CA2847302C/en active Active
- 2012-08-31 MY MYPI2014700440A patent/MY182178A/en unknown
- 2012-08-31 US US14/241,567 patent/US9630988B2/en active Active
- 2012-08-31 SG SG11201400260TA patent/SG11201400260TA/en unknown
- 2012-08-31 JP JP2014510575A patent/JP6363017B2/ja active Active
- 2012-08-31 CN CN201280053636.1A patent/CN103889555B/zh active Active
- 2012-08-31 AU AU2012303372A patent/AU2012303372A1/en not_active Abandoned
- 2012-08-31 BR BR112014004828A patent/BR112014004828B8/pt active IP Right Grant
- 2012-08-31 RU RU2014112230A patent/RU2638859C9/ru active
- 2012-08-31 WO PCT/JP2012/005536 patent/WO2013031237A1/en active Application Filing
- 2012-08-31 MX MX2014002253A patent/MX359235B/es active IP Right Grant
- 2012-08-31 EP EP12769502.1A patent/EP2750784A1/en not_active Ceased
-
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. |