SG11201901220XA - Methods of processing a fluid including a recombinant therapeutic protein and use thereof - Google Patents
Methods of processing a fluid including a recombinant therapeutic protein and use thereofInfo
- Publication number
- SG11201901220XA SG11201901220XA SG11201901220XA SG11201901220XA SG11201901220XA SG 11201901220X A SG11201901220X A SG 11201901220XA SG 11201901220X A SG11201901220X A SG 11201901220XA SG 11201901220X A SG11201901220X A SG 11201901220XA SG 11201901220X A SG11201901220X A SG 11201901220XA
- Authority
- SG
- Singapore
- Prior art keywords
- international
- therapeutic protein
- rule
- processing
- methods
- Prior art date
Links
- 239000012530 fluid Substances 0.000 title abstract 4
- 238000000034 method Methods 0.000 title abstract 4
- 229960000160 recombinant therapeutic protein Drugs 0.000 title abstract 3
- 239000003795 chemical substances by application Substances 0.000 abstract 2
- 238000009295 crossflow filtration Methods 0.000 abstract 2
- 239000008186 active pharmaceutical agent Substances 0.000 abstract 1
- 238000010924 continuous production Methods 0.000 abstract 1
- 229940088679 drug related substance Drugs 0.000 abstract 1
- 238000004519 manufacturing process Methods 0.000 abstract 1
- 230000008520 organization Effects 0.000 abstract 1
- 102000004169 proteins and genes Human genes 0.000 abstract 1
- 108090000623 proteins and genes Proteins 0.000 abstract 1
- 230000001225 therapeutic effect Effects 0.000 abstract 1
- 238000011100 viral filtration Methods 0.000 abstract 1
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
- B01D15/00—Separating processes involving the treatment of liquids with solid sorbents; Apparatus therefor
- B01D15/08—Selective adsorption, e.g. chromatography
- B01D15/10—Selective adsorption, e.g. chromatography characterised by constructional or operational features
- B01D15/18—Selective adsorption, e.g. chromatography characterised by constructional or operational features relating to flow patterns
- B01D15/1864—Selective adsorption, e.g. chromatography characterised by constructional or operational features relating to flow patterns using two or more columns
-
- 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
- B01D61/145—Ultrafiltration
- B01D61/146—Ultrafiltration comprising multiple ultrafiltration steps
-
- 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
- B01D61/58—Multistep processes
-
- 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
- C07K1/16—Extraction; Separation; Purification by chromatography
-
- 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
- C07K1/36—Extraction; Separation; Purification by a combination of two or more processes of different types
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
-
- 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
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
- B01D—SEPARATION
- B01D2315/00—Details relating to the membrane module operation
- B01D2315/06—Submerged-type; Immersion type
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
- B01D—SEPARATION
- B01D2315/00—Details relating to the membrane module operation
- B01D2315/16—Diafiltration
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K2317/00—Immunoglobulins specific features
- C07K2317/20—Immunoglobulins specific features characterized by taxonomic origin
- C07K2317/21—Immunoglobulins specific features characterized by taxonomic origin from primates, e.g. man
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K2317/00—Immunoglobulins specific features
- C07K2317/30—Immunoglobulins specific features characterized by aspects of specificity or valency
- C07K2317/31—Immunoglobulins specific features characterized by aspects of specificity or valency multispecific
Landscapes
- Chemical & Material Sciences (AREA)
- Engineering & Computer Science (AREA)
- Water Supply & Treatment (AREA)
- Organic Chemistry (AREA)
- Health & Medical Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Biophysics (AREA)
- General Health & Medical Sciences (AREA)
- Genetics & Genomics (AREA)
- Medicinal Chemistry (AREA)
- Molecular Biology (AREA)
- Biochemistry (AREA)
- Life Sciences & Earth Sciences (AREA)
- Analytical Chemistry (AREA)
- Immunology (AREA)
- Peptides Or Proteins (AREA)
- Micro-Organisms Or Cultivation Processes Thereof (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Medicines Containing Material From Animals Or Micro-Organisms (AREA)
- Enzymes And Modification Thereof (AREA)
- Preparation Of Compounds By Using Micro-Organisms (AREA)
- Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
- Separation Using Semi-Permeable Membranes (AREA)
- Treatment Of Liquids With Adsorbents In General (AREA)
- External Artificial Organs (AREA)
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US201662375689P | 2016-08-16 | 2016-08-16 | |
| PCT/US2017/046930 WO2018035116A1 (en) | 2016-08-16 | 2017-08-15 | Methods of processing a fluid including a recombinant therapeutic protein and use thereof |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| SG11201901220XA true SG11201901220XA (en) | 2019-03-28 |
Family
ID=59799450
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| SG11201901220XA SG11201901220XA (en) | 2016-08-16 | 2017-08-15 | Methods of processing a fluid including a recombinant therapeutic protein and use thereof |
Country Status (13)
| Country | Link |
|---|---|
| US (2) | US10968252B2 (enExample) |
| EP (2) | EP3500589B1 (enExample) |
| JP (3) | JP7106523B2 (enExample) |
| KR (1) | KR102465761B1 (enExample) |
| CN (1) | CN109843906B (enExample) |
| AU (1) | AU2017313042A1 (enExample) |
| BR (1) | BR112019003013A2 (enExample) |
| CA (1) | CA3034092A1 (enExample) |
| MX (2) | MX2019001859A (enExample) |
| RU (2) | RU2021119421A (enExample) |
| SG (1) | SG11201901220XA (enExample) |
| TW (1) | TWI767930B (enExample) |
| WO (1) | WO2018035116A1 (enExample) |
Families Citing this family (14)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2018035116A1 (en) | 2016-08-16 | 2018-02-22 | Genzyme Corporation | Methods of processing a fluid including a recombinant therapeutic protein and use thereof |
| WO2019096622A1 (en) * | 2017-11-16 | 2019-05-23 | Chromacon Ag | Method for monitoring, evaluating, and controlling a cyclic chromatographic purification process |
| TWI898645B (zh) | 2018-05-04 | 2025-09-21 | 美商健臻公司 | 灌注式細胞培養裝置 |
| JP7702875B2 (ja) | 2019-03-11 | 2025-07-04 | ジェンザイム・コーポレーション | 接線方向ウイルス濾過 |
| KR20210148274A (ko) * | 2019-04-01 | 2021-12-07 | 베링거 인겔하임 인터내셔날 게엠베하 | 통합된 연속적인 재조합 단백질의 제조 |
| JP7568638B2 (ja) * | 2019-04-03 | 2024-10-16 | ジェンザイム・コーポレーション | 組換えタンパク質の連続的生産 |
| WO2020258515A1 (zh) * | 2019-06-28 | 2020-12-30 | 浙江大学 | 多柱连续流层析设计及分析的方法 |
| BR112022005211A2 (pt) * | 2019-09-23 | 2022-06-14 | Genzyme Corp | Medição de atributos de qualidade do produto |
| BR112022007525A2 (pt) | 2019-10-22 | 2022-07-12 | Genzyme Corp | Monitoramento de produto em linha na biofabricação contínua integrada |
| KR20240046650A (ko) * | 2020-09-14 | 2024-04-09 | 엔퀴스트 테크놀로지스 아이엔씨. | 생물학적 생성물의 제조 및 다운스트림 정제를 위한 공정 기술 |
| US12458908B2 (en) * | 2020-11-30 | 2025-11-04 | PAK Biosolutions Inc. | End-to-end continuous purification system |
| KR20240039642A (ko) * | 2022-09-19 | 2024-03-27 | 주식회사 녹십자 | 신규 헤파란-n-설파타아제의 정제 방법 |
| US12157873B2 (en) | 2022-09-28 | 2024-12-03 | Genzyme Corporation | Systems and devices for producing biological products and methods of using the same |
| EP4397323A1 (de) * | 2023-01-09 | 2024-07-10 | Sartorius Stedim Biotech GmbH | Verfahren zur inaktivierung von viren in einem fluid |
Family Cites Families (19)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CH692479A5 (de) * | 1997-07-08 | 2002-07-15 | Bucher Guyer Ag | Querstrom-Filtrationsanlage sowie Verfahren zum Betrieb einer solchen Anlage. |
| GB9821342D0 (en) | 1998-10-02 | 1998-11-25 | Common Services Agency | Device for treatment of biological fluids |
| US6214221B1 (en) * | 1999-02-22 | 2001-04-10 | Henry B. Kopf | Method and apparatus for purification of biological substances |
| US6296770B1 (en) * | 1999-12-09 | 2001-10-02 | Eastman Kodak Company | Constant concentration at the UF membrane wall UF process control and apparatus |
| US6365395B1 (en) * | 2000-11-03 | 2002-04-02 | Millipore Corporation | Process for removing protein aggregates and virus from a protein solution |
| CA2428332C (en) | 2000-11-13 | 2010-05-25 | Bayer Aktiengesellschaft | Method of inactivating microorganisms in a fluid using ultraviolet radiation |
| HUE025101T2 (en) * | 2002-04-26 | 2016-02-29 | Genentech Inc | Purification of proteins other than affinity purification |
| US20060051347A1 (en) * | 2004-09-09 | 2006-03-09 | Winter Charles M | Process for concentration of antibodies and therapeutic products thereof |
| US7384549B2 (en) * | 2005-12-29 | 2008-06-10 | Spf Innovations, Llc | Method and apparatus for the filtration of biological solutions |
| US20080017576A1 (en) * | 2006-06-15 | 2008-01-24 | Rensselaer Polytechnic Institute | Global model for optimizing crossflow microfiltration and ultrafiltration processes |
| WO2008073620A2 (en) * | 2006-11-02 | 2008-06-19 | Neose Technologies, Inc. | Manufacturing process for the production of polypeptides expressed in insect cell-lines |
| US7988859B2 (en) | 2009-02-05 | 2011-08-02 | Chromatan Inc. | Countercurrent tangential chromatography methods, systems, and apparatus |
| US20100237013A1 (en) * | 2009-02-13 | 2010-09-23 | Millipore Corporation | Autonomous filter element |
| US8728479B2 (en) | 2009-03-31 | 2014-05-20 | The Trustees Of The University Of Pennsylvania | Antigen-binding proteins comprising recombinant protein scaffolds |
| CA2782908C (en) | 2009-12-11 | 2016-02-09 | Edward Weisselberg | Apparatus and method for continuous lyophilization |
| BR112015009553A2 (pt) | 2012-10-30 | 2017-10-03 | Hoffmann La Roche | Método para separar uma proteína de interesse de uma solução de cultura de células |
| US10030063B2 (en) * | 2012-12-18 | 2018-07-24 | Novartis Ag | Production of therapeutic proteins in genetically modified mammalian cells |
| RU2768003C2 (ru) | 2013-03-08 | 2022-03-22 | Джензим Корпорейшн | Интегрированное непрерывное производство терапевтических белковых лекарственных веществ |
| WO2018035116A1 (en) | 2016-08-16 | 2018-02-22 | Genzyme Corporation | Methods of processing a fluid including a recombinant therapeutic protein and use thereof |
-
2017
- 2017-08-15 WO PCT/US2017/046930 patent/WO2018035116A1/en not_active Ceased
- 2017-08-15 EP EP17762255.2A patent/EP3500589B1/en active Active
- 2017-08-15 AU AU2017313042A patent/AU2017313042A1/en not_active Abandoned
- 2017-08-15 MX MX2019001859A patent/MX2019001859A/es unknown
- 2017-08-15 BR BR112019003013-1A patent/BR112019003013A2/pt not_active IP Right Cessation
- 2017-08-15 RU RU2021119421A patent/RU2021119421A/ru unknown
- 2017-08-15 KR KR1020197007518A patent/KR102465761B1/ko active Active
- 2017-08-15 JP JP2019508971A patent/JP7106523B2/ja active Active
- 2017-08-15 RU RU2019107142A patent/RU2751506C2/ru active
- 2017-08-15 CN CN201780063527.0A patent/CN109843906B/zh active Active
- 2017-08-15 CA CA3034092A patent/CA3034092A1/en active Pending
- 2017-08-15 SG SG11201901220XA patent/SG11201901220XA/en unknown
- 2017-08-15 TW TW106127646A patent/TWI767930B/zh not_active IP Right Cessation
- 2017-08-15 EP EP21193609.1A patent/EP3950702A1/en active Pending
- 2017-08-15 US US15/677,888 patent/US10968252B2/en active Active
-
2019
- 2019-02-14 MX MX2021015165A patent/MX2021015165A/es unknown
-
2021
- 2021-02-19 US US17/180,272 patent/US11884703B2/en active Active
-
2022
- 2022-05-20 JP JP2022082749A patent/JP2022110128A/ja active Pending
-
2024
- 2024-03-27 JP JP2024050645A patent/JP2024079790A/ja active Pending
Also Published As
| Publication number | Publication date |
|---|---|
| EP3500589A1 (en) | 2019-06-26 |
| TWI767930B (zh) | 2022-06-21 |
| RU2019107142A3 (enExample) | 2020-12-17 |
| JP2024079790A (ja) | 2024-06-11 |
| RU2751506C2 (ru) | 2021-07-14 |
| US20210171572A1 (en) | 2021-06-10 |
| MX2021015165A (es) | 2022-01-18 |
| US20180051054A1 (en) | 2018-02-22 |
| BR112019003013A2 (pt) | 2019-05-14 |
| MX2019001859A (es) | 2019-08-29 |
| RU2019107142A (ru) | 2020-09-18 |
| US10968252B2 (en) | 2021-04-06 |
| CA3034092A1 (en) | 2018-02-22 |
| EP3950702A1 (en) | 2022-02-09 |
| AU2017313042A1 (en) | 2019-04-04 |
| KR102465761B1 (ko) | 2022-11-09 |
| CN109843906B (zh) | 2023-09-01 |
| WO2018035116A1 (en) | 2018-02-22 |
| CN109843906A (zh) | 2019-06-04 |
| RU2021119421A (ru) | 2021-07-13 |
| JP2022110128A (ja) | 2022-07-28 |
| JP2019532916A (ja) | 2019-11-14 |
| JP7106523B2 (ja) | 2022-07-26 |
| EP3500589B1 (en) | 2022-05-04 |
| KR20190046872A (ko) | 2019-05-07 |
| TW201811816A (zh) | 2018-04-01 |
| US11884703B2 (en) | 2024-01-30 |
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