PL3235557T3 - Sposób wytwarzania kompozycji zawierającej wysoko stężone przeciwciała za pomocą ultrafiltracji - Google Patents
Sposób wytwarzania kompozycji zawierającej wysoko stężone przeciwciała za pomocą ultrafiltracjiInfo
- Publication number
- PL3235557T3 PL3235557T3 PL17170961.1T PL17170961T PL3235557T3 PL 3235557 T3 PL3235557 T3 PL 3235557T3 PL 17170961 T PL17170961 T PL 17170961T PL 3235557 T3 PL3235557 T3 PL 3235557T3
- Authority
- PL
- Poland
- Prior art keywords
- ultrafiltration
- preparing
- composition
- highly concentrated
- concentrated antibodies
- Prior art date
Links
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
-
- 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
-
- 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
-
- 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
-
- 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
Landscapes
- Chemical & Material Sciences (AREA)
- Health & Medical Sciences (AREA)
- Engineering & Computer Science (AREA)
- Water Supply & Treatment (AREA)
- Organic Chemistry (AREA)
- Life Sciences & Earth Sciences (AREA)
- Medicinal Chemistry (AREA)
- Immunology (AREA)
- General Health & Medical Sciences (AREA)
- Genetics & Genomics (AREA)
- Biochemistry (AREA)
- Molecular Biology (AREA)
- Biophysics (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Analytical Chemistry (AREA)
- Microbiology (AREA)
- Epidemiology (AREA)
- Animal Behavior & Ethology (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Pharmacology & Pharmacy (AREA)
- Mycology (AREA)
- Bioinformatics & Cheminformatics (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)
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US201161530158P | 2011-09-01 | 2011-09-01 |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| PL3235557T3 true PL3235557T3 (pl) | 2025-09-01 |
Family
ID=46982845
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| PL17170961.1T PL3235557T3 (pl) | 2011-09-01 | 2012-08-31 | Sposób wytwarzania kompozycji zawierającej wysoko stężone przeciwciała za pomocą ultrafiltracji |
Country Status (19)
| Country | Link |
|---|---|
| US (3) | US9630988B2 (pl) |
| EP (2) | EP2750784A1 (pl) |
| JP (2) | JP6363017B2 (pl) |
| KR (1) | KR101993488B1 (pl) |
| CN (1) | CN103889555B (pl) |
| AU (2) | AU2012303372A1 (pl) |
| BR (1) | BR112014004828B8 (pl) |
| CA (1) | CA2847302C (pl) |
| ES (1) | ES3027863T3 (pl) |
| HR (1) | HRP20250713T8 (pl) |
| HU (1) | HUE072741T2 (pl) |
| IL (1) | IL231128B (pl) |
| MX (1) | MX359235B (pl) |
| MY (1) | MY182178A (pl) |
| PL (1) | PL3235557T3 (pl) |
| RU (1) | RU2638859C9 (pl) |
| SG (1) | SG11201400260TA (pl) |
| WO (1) | WO2013031237A1 (pl) |
| ZA (1) | ZA201401184B (pl) |
Families Citing this family (23)
| 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 |
| BR122022001178B1 (pt) | 2009-10-26 | 2022-10-04 | F. Hoffmann-La Roche Ag | Método para a produção de uma imunoglobulina glicosilada e seu uso |
| KR20130086628A (ko) | 2010-11-08 | 2013-08-02 | 제넨테크, 인크. | 피하 투여용 항―ｉｌ―6 수용체 항체 |
| DK2739157T3 (en) * | 2011-08-03 | 2018-01-08 | Prolacta Bioscience Inc | Microfiltration of human milk to reduce bacterial contamination |
| PL3235557T3 (pl) | 2011-09-01 | 2025-09-01 | Chugai Seiyaku Kabushiki Kaisha | Sposób wytwarzania kompozycji zawierającej wysoko stężone przeciwciała za pomocą ultrafiltracji |
| BR112015032960B1 (pt) | 2013-07-04 | 2021-01-05 | F. Hoffmann-La Roche Ag | imunoensaio suprimido por interferência para detectar anticorpos anti-fármaco em amostras de soro |
| 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 |
| CN112533989A (zh) | 2018-07-27 | 2021-03-19 | Arc医疗器械股份有限公司 | 用于治疗纤维性粘连的高度纯化和/或修饰的褐藻糖胶组合物 |
| US12186334B2 (en) | 2018-07-27 | 2025-01-07 | ARC Medical Inc. | High-molecular-weight fucans for treating fibrous adhesions and other diseases and conditions |
| PT3837273T (pt) * | 2018-08-14 | 2025-12-26 | Bristol Myers Squibb Co | Recuperação melhorada de proteínas |
| EP3852904A1 (en) * | 2018-09-21 | 2021-07-28 | Cytiva Sweden AB | Perfusion bioprocessing system and method of operating the same |
| 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 |
| CN115873064A (zh) * | 2022-09-27 | 2023-03-31 | 英脉生物医药(杭州)有限公司 | 高浓度蛋白样品的制备装置及方法 |
| WO2025054398A1 (en) * | 2023-09-08 | 2025-03-13 | Genentech, Inc. | High viscosity ultrafiltration/diafiltration and single-pass tangential flow filtration processes |
Family Cites Families (35)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JPS6443305A (en) | 1987-08-10 | 1989-02-15 | Fuji Photo Film Co Ltd | Cross flow type filtration process |
| JPH0368432A (ja) * | 1989-07-14 | 1991-03-25 | Dow Chem Co:The | 等方性又は異方性微孔性シンジオタクチックポリスチレン膜及びその製造法 |
| 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 |
| US5795965A (en) | 1991-04-25 | 1998-08-18 | Chugai Seiyaku Kabushiki Kaisha | Reshaped human to 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 |
| KR100847441B1 (ko) | 1996-09-26 | 2008-07-21 | 츄가이 세이야꾸 가부시키가이샤 | 인간의 부갑상선 호르몬 관련 펩티드에 대한 항체 |
| 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 |
| EP0931097B1 (en) | 1996-10-10 | 2005-09-14 | Neose Technologies, Inc. | Carbohydrate purification using 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 |
| DK1069185T3 (da) | 1998-04-03 | 2011-06-27 | Chugai Pharmaceutical Co Ltd | Humaniseret antistof mod human vævsfaktor (TF) og fremgangsmåde til at konstruere humaniseret antistof |
| DE19827473C1 (de) | 1998-06-19 | 1999-08-26 | Sartorius Gmbh | Verbesserte Crossflow-Filterkassetten |
| TWI241345B (en) | 2000-03-10 | 2005-10-11 | Chugai Pharmaceutical Co Ltd | Apoptosis inducing polypeptide |
| US6350382B1 (en) | 2000-06-23 | 2002-02-26 | Scilog, Inc. | Enhancing filtration yields in tangential flow filtration |
| AU1344102A (en) | 2000-10-12 | 2002-04-22 | Genentech Inc | Reduced-viscosity concentrated protein formulations |
| CA2424364A1 (en) | 2000-10-20 | 2003-04-01 | Chugai Seiyaku Kabushiki Kaisha | Degraded tpo agonist antibody |
| WO2002092802A1 (en) * | 2001-05-14 | 2002-11-21 | Diversa Corporation | Novel methods of enzyme purification |
| WO2004001007A2 (en) * | 2002-06-21 | 2003-12-31 | Idec Pharmaceuticals Corporation | Buffered formulations for concentrating antibodies and methods of use thereof |
| CN1759189A (zh) | 2003-02-24 | 2006-04-12 | Gtc生物治疗学公司 | 切向流过滤方法及其装置 |
| 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 |
| AU2005211855C1 (en) * | 2004-02-18 | 2010-07-15 | Bucher Guyer Ag | Method for the diafiltration of a product and device for carrying out said method |
| 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 |
| KR20160074019A (ko) | 2007-12-05 | 2016-06-27 | 추가이 세이야쿠 가부시키가이샤 | 항ｎｒ１０ 항체 및 그의 이용 |
| PE20091174A1 (es) | 2007-12-27 | 2009-08-03 | Chugai Pharmaceutical Co Ltd | Formulacion liquida con contenido de alta concentracion de anticuerpo |
| CN102124027B (zh) * | 2008-05-15 | 2015-01-21 | 温氏健康有限公司 | 产生富含分泌型免疫球蛋白的乳组分的方法 |
| 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 |
| EP2411125B1 (en) * | 2009-03-24 | 2019-05-08 | 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 |
| TWI505838B (zh) | 2010-01-20 | 2015-11-01 | Chugai Pharmaceutical Co Ltd | Stabilized antibody solution containing |
| PL3235557T3 (pl) | 2011-09-01 | 2025-09-01 | Chugai Seiyaku Kabushiki Kaisha | Sposób wytwarzania kompozycji zawierającej wysoko stężone przeciwciała za pomocą ultrafiltracji |
-
2012
- 2012-08-31 PL PL17170961.1T patent/PL3235557T3/pl unknown
- 2012-08-31 ES ES17170961T patent/ES3027863T3/es active Active
- 2012-08-31 HU HUE17170961A patent/HUE072741T2/hu unknown
- 2012-08-31 MX MX2014002253A patent/MX359235B/es active IP Right Grant
- 2012-08-31 JP JP2014510575A patent/JP6363017B2/ja active Active
- 2012-08-31 HR HRP20250713TT patent/HRP20250713T8/hr unknown
- 2012-08-31 AU AU2012303372A patent/AU2012303372A1/en not_active Abandoned
- 2012-08-31 CN CN201280053636.1A patent/CN103889555B/zh active Active
- 2012-08-31 SG SG11201400260TA patent/SG11201400260TA/en unknown
- 2012-08-31 RU RU2014112230A patent/RU2638859C9/ru active
- 2012-08-31 WO PCT/JP2012/005536 patent/WO2013031237A1/en not_active Ceased
- 2012-08-31 US US14/241,567 patent/US9630988B2/en active Active
- 2012-08-31 MY MYPI2014700440A patent/MY182178A/en unknown
- 2012-08-31 KR KR1020147008464A patent/KR101993488B1/ko active Active
- 2012-08-31 EP EP12769502.1A patent/EP2750784A1/en not_active Ceased
- 2012-08-31 BR BR112014004828A patent/BR112014004828B8/pt active IP Right Grant
- 2012-08-31 EP EP17170961.1A patent/EP3235557B1/en active Active
- 2012-08-31 CA CA2847302A patent/CA2847302C/en active Active
-
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/US12209109B2/en active Active
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