BR112019003013A2 - métodos de processamento de um fluido incluindo uma proteína terapêutica recombinante e uso do mesmo - Google Patents

métodos de processamento de um fluido incluindo uma proteína terapêutica recombinante e uso do mesmo

Info

Publication number
BR112019003013A2
BR112019003013A2 BR112019003013-1A BR112019003013A BR112019003013A2 BR 112019003013 A2 BR112019003013 A2 BR 112019003013A2 BR 112019003013 A BR112019003013 A BR 112019003013A BR 112019003013 A2 BR112019003013 A2 BR 112019003013A2
Authority
BR
Brazil
Prior art keywords
therapeutic protein
methods
processing
recombinant therapeutic
fluid including
Prior art date
Application number
BR112019003013-1A
Other languages
English (en)
Portuguese (pt)
Inventor
Vetter Tarl
Coolbaugh Michael
Warikoo Veena
Konstantinov Konstantin
Original Assignee
Genzyme Corporation
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Genzyme Corporation filed Critical Genzyme Corporation
Publication of BR112019003013A2 publication Critical patent/BR112019003013A2/pt

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
    • 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)
  • Molecular Biology (AREA)
  • Biochemistry (AREA)
  • Biophysics (AREA)
  • General Health & Medical Sciences (AREA)
  • Genetics & Genomics (AREA)
  • Medicinal Chemistry (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Proteomics, Peptides & Aminoacids (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)
BR112019003013-1A 2016-08-16 2017-08-15 métodos de processamento de um fluido incluindo uma proteína terapêutica recombinante e uso do mesmo BR112019003013A2 (pt)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US201662375689P 2016-08-16 2016-08-16
US62/375,689 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
BR112019003013A2 true BR112019003013A2 (pt) 2019-05-14

Family

ID=59799450

Family Applications (1)

Application Number Title Priority Date Filing Date
BR112019003013-1A BR112019003013A2 (pt) 2016-08-16 2017-08-15 métodos de processamento de um fluido incluindo uma proteína terapêutica recombinante e uso do mesmo

Country Status (13)

Country Link
US (2) US10968252B2 (enExample)
EP (2) EP3950702A1 (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) RU2751506C2 (enExample)
SG (1) SG11201901220XA (enExample)
TW (1) TWI767930B (enExample)
WO (1) WO2018035116A1 (enExample)

Families Citing this family (14)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
TWI767930B (zh) 2016-08-16 2022-06-21 美商健臻公司 處理包括重組治療性蛋白之流體的方法及其用途
SG11202003440SA (en) * 2017-11-16 2020-05-28 Chromacon Ag Method for monitoring, evaluating, and controlling a cyclic chromatographic purification process
TWI846694B (zh) * 2018-05-04 2024-07-01 美商健臻公司 具有過濾系統的灌注式生物反應器
MX2021010891A (es) 2019-03-11 2021-12-10 Genzyme Corp Filtracion tangencial de virus.
KR20210148274A (ko) * 2019-04-01 2021-12-07 베링거 인겔하임 인터내셔날 게엠베하 통합된 연속적인 재조합 단백질의 제조
AU2020253381A1 (en) 2019-04-03 2021-12-02 Genzyme Corporation Continuous production of recombinant proteins
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
TW202532844A (zh) * 2019-09-23 2025-08-16 美商健臻公司 用於測量生物樣品的分析物的多個產品品質屬性的方法
AU2020372397A1 (en) 2019-10-22 2022-06-09 Genzyme Corporation In-line product monitoring in integrated continuous bio-manufacturing
AU2021340897B2 (en) * 2020-09-14 2023-05-25 Enquyst Technologies Inc. Process technology for biological product manufacturing and downstream purification
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
WO2024072963A1 (en) 2022-09-28 2024-04-04 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)

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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
AU2002229545B2 (en) 2000-11-13 2007-08-30 Bayer Aktiengesellschaft Method of inactivating microorganisms in a fluid using ultraviolet radiation
JP4319979B2 (ja) * 2002-04-26 2009-08-26 ジェネンテック・インコーポレーテッド タンパク質の非アフィニティ精製
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
EP2509873B1 (en) 2009-12-11 2019-03-20 Wyssmont Company Inc. Apparatus and method for continuous lyophilization
SI2914612T1 (sl) 2012-10-30 2019-03-29 F. Hoffmann-La Roche Ag Čiščenje polipeptidov z uporabo dvostopenjske tangencialne ultrafiltracije
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
HK1219964A1 (zh) * 2013-03-08 2017-04-21 Genzyme Corporation 治疗性蛋白药物物质的整合连续制造
TWI767930B (zh) 2016-08-16 2022-06-21 美商健臻公司 處理包括重組治療性蛋白之流體的方法及其用途

Also Published As

Publication number Publication date
RU2019107142A3 (enExample) 2020-12-17
EP3950702A1 (en) 2022-02-09
RU2021119421A (ru) 2021-07-13
MX2021015165A (es) 2022-01-18
EP3500589A1 (en) 2019-06-26
AU2017313042A1 (en) 2019-04-04
EP3500589B1 (en) 2022-05-04
TW201811816A (zh) 2018-04-01
RU2019107142A (ru) 2020-09-18
CN109843906B (zh) 2023-09-01
US10968252B2 (en) 2021-04-06
JP2019532916A (ja) 2019-11-14
US11884703B2 (en) 2024-01-30
WO2018035116A1 (en) 2018-02-22
TWI767930B (zh) 2022-06-21
RU2751506C2 (ru) 2021-07-14
SG11201901220XA (en) 2019-03-28
JP2024079790A (ja) 2024-06-11
KR102465761B1 (ko) 2022-11-09
CA3034092A1 (en) 2018-02-22
US20180051054A1 (en) 2018-02-22
JP7106523B2 (ja) 2022-07-26
CN109843906A (zh) 2019-06-04
MX2019001859A (es) 2019-08-29
US20210171572A1 (en) 2021-06-10
JP2022110128A (ja) 2022-07-28
KR20190046872A (ko) 2019-05-07

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Legal Events

Date Code Title Description
B350 Update of information on the portal [chapter 15.35 patent gazette]
B06W Patent application suspended after preliminary examination (for patents with searches from other patent authorities) chapter 6.23 patent gazette]
B08F Application dismissed because of non-payment of annual fees [chapter 8.6 patent gazette]

Free format text: REFERENTE A 8A ANUIDADE.

B08K Patent lapsed as no evidence of payment of the annual fee has been furnished to inpi [chapter 8.11 patent gazette]

Free format text: EM VIRTUDE DO ARQUIVAMENTO PUBLICADO NA RPI 2846 DE 22-07-2025 E CONSIDERANDO AUSENCIA DE MANIFESTACAO DENTRO DOS PRAZOS LEGAIS, INFORMO QUE CABE SER MANTIDO O ARQUIVAMENTO DO PEDIDO DE PATENTE, CONFORME O DISPOSTO NO ARTIGO 12, DA RESOLUCAO 113/2013.