MX2019001859A - Metodos de procesamiento de un fluido que incluye una proteina terapeutica recombinante y uso de los mismos. - Google Patents
Metodos de procesamiento de un fluido que incluye una proteina terapeutica recombinante y uso de los mismos.Info
- Publication number
- MX2019001859A MX2019001859A MX2019001859A MX2019001859A MX2019001859A MX 2019001859 A MX2019001859 A MX 2019001859A MX 2019001859 A MX2019001859 A MX 2019001859A MX 2019001859 A MX2019001859 A MX 2019001859A MX 2019001859 A MX2019001859 A MX 2019001859A
- Authority
- MX
- Mexico
- Prior art keywords
- processing
- methods
- therapeutic protein
- recombinant therapeutic
- fluid including
- Prior art date
Links
- 239000012530 fluid Substances 0.000 title abstract 3
- 238000000034 method Methods 0.000 title abstract 3
- 229960000160 recombinant therapeutic protein Drugs 0.000 title 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
- 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)
- Organic Chemistry (AREA)
- Engineering & Computer Science (AREA)
- Water Supply & Treatment (AREA)
- Health & Medical Sciences (AREA)
- Molecular Biology (AREA)
- Life Sciences & Earth Sciences (AREA)
- Biochemistry (AREA)
- Biophysics (AREA)
- General Health & Medical Sciences (AREA)
- Genetics & Genomics (AREA)
- Medicinal Chemistry (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Analytical Chemistry (AREA)
- Chemical Kinetics & Catalysis (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)
Abstract
En la presente especificación se proporcionan métodos de procesamiento de un fluido que incluyen el uso de uno o ambos de un sistema de circuito que incluye una unidad de filtración de flujo tangencial (TFF) y un sistema de circuito que incluye una unidad de filtración de virus de flujo tangencial (TFVF). Asimismo, se proporcionan procedimientos integrados y continuos para fabricar un principio activo de proteína terapéutica que incluyen una etapa de procesamiento de un fluido que incluye la proteína terapéutica recombinante utilizando cualquiera de los métodos proporcionados en la presente especificación.
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 |
|---|---|
| MX2019001859A true MX2019001859A (es) | 2019-08-29 |
Family
ID=59799450
Family Applications (2)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| MX2019001859A MX2019001859A (es) | 2016-08-16 | 2017-08-15 | Metodos de procesamiento de un fluido que incluye una proteina terapeutica recombinante y uso de los mismos. |
| MX2021015165A MX2021015165A (es) | 2016-08-16 | 2019-02-14 | Metodos de procesamiento de un fluido que incluye una proteina terapeutica recombinante y uso de los mismos. |
Family Applications After (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| MX2021015165A MX2021015165A (es) | 2016-08-16 | 2019-02-14 | Metodos de procesamiento de un fluido que incluye una proteina terapeutica recombinante y uso de los mismos. |
Country Status (13)
| Country | Link |
|---|---|
| US (2) | US10968252B2 (es) |
| EP (2) | EP3500589B1 (es) |
| JP (3) | JP7106523B2 (es) |
| KR (1) | KR102465761B1 (es) |
| CN (1) | CN109843906B (es) |
| AU (1) | AU2017313042A1 (es) |
| BR (1) | BR112019003013A2 (es) |
| CA (1) | CA3034092A1 (es) |
| MX (2) | MX2019001859A (es) |
| RU (2) | RU2751506C2 (es) |
| SG (1) | SG11201901220XA (es) |
| TW (1) | TWI767930B (es) |
| WO (1) | WO2018035116A1 (es) |
Families Citing this family (7)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| MX2019001859A (es) | 2016-08-16 | 2019-08-29 | Genzyme Corp | Metodos de procesamiento de un fluido que incluye una proteina terapeutica recombinante y uso de los mismos. |
| SI3512616T2 (sl) * | 2017-11-16 | 2022-11-30 | Chromacon Ag | Postopek za spremljanje, ocenjevanje in krmiljenje procesa cikličnega kromatografskega čiščenja |
| US20190338238A1 (en) * | 2018-05-04 | 2019-11-07 | Genzyme Corporation | Perfusion Bioreactor With Filtration Systems |
| MX2021010891A (es) | 2019-03-11 | 2021-12-10 | Genzyme Corp | Filtracion tangencial de virus. |
| SG11202110909XA (en) | 2019-04-03 | 2021-10-28 | Genzyme Corp | Continuous production of recombinant proteins |
| CN114585723A (zh) | 2019-10-22 | 2022-06-03 | 建新公司 | 集成连续生物制造中的在线产物监测 |
| KR20240039642A (ko) * | 2022-09-19 | 2024-03-27 | 주식회사 녹십자 | 신규 헤파란-n-설파타아제의 정제 방법 |
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 |
| JP4116429B2 (ja) | 2000-11-13 | 2008-07-09 | バイエル アクチェンゲゼルシャフト | 紫外線放射を用いて流体中の微生物を不活性化する方法 |
| DK1501369T3 (en) * | 2002-04-26 | 2015-09-28 | Genentech Inc | Non-affinity purification of proteins |
| 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 |
| US20080207487A1 (en) * | 2006-11-02 | 2008-08-28 | 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 |
| WO2011071676A1 (en) | 2009-12-11 | 2011-06-16 | Wyssmont Company Inc. | Apparatus and method for continuous lyophilization |
| KR20150079830A (ko) | 2012-10-30 | 2015-07-08 | 에프. 호프만-라 로슈 아게 | 듀얼 스테이지 접선 유동 한외여과를 사용하는 폴리펩타이드의 정제 |
| JP6392245B2 (ja) * | 2012-12-18 | 2018-09-19 | ノバルティス アーゲー | 遺伝子改変哺乳動物細胞における治療用タンパク質の産生 |
| SG10201709131UA (en) * | 2013-03-08 | 2017-12-28 | Genzyme Corp | Continuous purification of therapeutic proteins |
| MX2019001859A (es) | 2016-08-16 | 2019-08-29 | Genzyme Corp | Metodos de procesamiento de un fluido que incluye una proteina terapeutica recombinante y uso de los mismos. |
-
2017
- 2017-08-15 MX MX2019001859A patent/MX2019001859A/es unknown
- 2017-08-15 US US15/677,888 patent/US10968252B2/en active Active
- 2017-08-15 AU AU2017313042A patent/AU2017313042A1/en active Pending
- 2017-08-15 EP EP17762255.2A patent/EP3500589B1/en active Active
- 2017-08-15 RU RU2019107142A patent/RU2751506C2/ru active
- 2017-08-15 JP JP2019508971A patent/JP7106523B2/ja active Active
- 2017-08-15 WO PCT/US2017/046930 patent/WO2018035116A1/en unknown
- 2017-08-15 RU RU2021119421A patent/RU2021119421A/ru unknown
- 2017-08-15 BR BR112019003013-1A patent/BR112019003013A2/pt unknown
- 2017-08-15 CN CN201780063527.0A patent/CN109843906B/zh active Active
- 2017-08-15 TW TW106127646A patent/TWI767930B/zh active
- 2017-08-15 CA CA3034092A patent/CA3034092A1/en active Pending
- 2017-08-15 SG SG11201901220XA patent/SG11201901220XA/en unknown
- 2017-08-15 KR KR1020197007518A patent/KR102465761B1/ko active IP Right Grant
- 2017-08-15 EP EP21193609.1A patent/EP3950702A1/en active Pending
-
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 |
|---|---|
| JP2019532916A (ja) | 2019-11-14 |
| US10968252B2 (en) | 2021-04-06 |
| RU2751506C2 (ru) | 2021-07-14 |
| JP7106523B2 (ja) | 2022-07-26 |
| WO2018035116A1 (en) | 2018-02-22 |
| AU2017313042A1 (en) | 2019-04-04 |
| EP3500589B1 (en) | 2022-05-04 |
| BR112019003013A2 (pt) | 2019-05-14 |
| JP2022110128A (ja) | 2022-07-28 |
| RU2019107142A (ru) | 2020-09-18 |
| MX2021015165A (es) | 2022-01-18 |
| US20180051054A1 (en) | 2018-02-22 |
| TWI767930B (zh) | 2022-06-21 |
| KR102465761B1 (ko) | 2022-11-09 |
| US20210171572A1 (en) | 2021-06-10 |
| SG11201901220XA (en) | 2019-03-28 |
| CN109843906A (zh) | 2019-06-04 |
| CN109843906B (zh) | 2023-09-01 |
| CA3034092A1 (en) | 2018-02-22 |
| RU2021119421A (ru) | 2021-07-13 |
| EP3500589A1 (en) | 2019-06-26 |
| KR20190046872A (ko) | 2019-05-07 |
| US11884703B2 (en) | 2024-01-30 |
| JP2024079790A (ja) | 2024-06-11 |
| TW201811816A (zh) | 2018-04-01 |
| EP3950702A1 (en) | 2022-02-09 |
| RU2019107142A3 (es) | 2020-12-17 |
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