BR112018003127A2 - purificação de fkpa e usos do mesmo para produzir polipeptídeos recombinantes - Google Patents

purificação de fkpa e usos do mesmo para produzir polipeptídeos recombinantes

Info

Publication number
BR112018003127A2
BR112018003127A2 BR112018003127A BR112018003127A BR112018003127A2 BR 112018003127 A2 BR112018003127 A2 BR 112018003127A2 BR 112018003127 A BR112018003127 A BR 112018003127A BR 112018003127 A BR112018003127 A BR 112018003127A BR 112018003127 A2 BR112018003127 A2 BR 112018003127A2
Authority
BR
Brazil
Prior art keywords
fkpa
methods
bacteria
purification
multispecific antibodies
Prior art date
Application number
BR112018003127A
Other languages
English (en)
Inventor
Ladiwala Asif
B Fong Chris
A Mckay Patrick
Original Assignee
Genentech Inc
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 Genentech Inc filed Critical Genentech Inc
Publication of BR112018003127A2 publication Critical patent/BR112018003127A2/pt

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Classifications

    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K1/00General methods for the preparation of peptides, i.e. processes for the organic chemical preparation of peptides or proteins of any length
    • C07K1/14Extraction; Separation; Purification
    • C07K1/16Extraction; Separation; Purification by chromatography
    • C07K1/165Extraction; Separation; Purification by chromatography mixed-mode chromatography
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K1/00General methods for the preparation of peptides, i.e. processes for the organic chemical preparation of peptides or proteins of any length
    • C07K1/14Extraction; Separation; Purification
    • C07K1/16Extraction; Separation; Purification by chromatography
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K1/00General methods for the preparation of peptides, i.e. processes for the organic chemical preparation of peptides or proteins of any length
    • C07K1/14Extraction; Separation; Purification
    • C07K1/16Extraction; Separation; Purification by chromatography
    • C07K1/18Ion-exchange chromatography
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K1/00General methods for the preparation of peptides, i.e. processes for the organic chemical preparation of peptides or proteins of any length
    • C07K1/14Extraction; Separation; Purification
    • C07K1/16Extraction; Separation; Purification by chromatography
    • C07K1/20Partition-, reverse-phase or hydrophobic interaction chromatography
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K1/00General methods for the preparation of peptides, i.e. processes for the organic chemical preparation of peptides or proteins of any length
    • C07K1/14Extraction; Separation; Purification
    • C07K1/16Extraction; Separation; Purification by chromatography
    • C07K1/22Affinity chromatography or related techniques based upon selective absorption processes
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K14/00Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • C07K14/195Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from bacteria
    • C07K14/24Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from bacteria from Enterobacteriaceae (F), e.g. Citrobacter, Serratia, Proteus, Providencia, Morganella, Yersinia
    • C07K14/245Escherichia (G)
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K16/00Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/06Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies from serum
    • C07K16/065Purification, fragmentation
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K16/00Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/12Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from bacteria
    • C07K16/1203Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from bacteria from Gram-negative bacteria
    • C07K16/1228Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from bacteria from Gram-negative bacteria from Enterobacteriaceae (F), e.g. Citrobacter, Serratia, Proteus, Providencia, Morganella, Yersinia
    • C07K16/1232Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from bacteria from Gram-negative bacteria from Enterobacteriaceae (F), e.g. Citrobacter, Serratia, Proteus, Providencia, Morganella, Yersinia from Escherichia (G)
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K16/00Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/18Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/24Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against cytokines, lymphokines or interferons
    • C07K16/244Interleukins [IL]
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K16/00Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/40Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against enzymes
    • CCHEMISTRY; METALLURGY
    • C12BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12NMICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
    • C12N9/00Enzymes; Proenzymes; Compositions thereof; Processes for preparing, activating, inhibiting, separating or purifying enzymes
    • C12N9/90Isomerases (5.)
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/53Immunoassay; Biospecific binding assay; Materials therefor
    • G01N33/563Immunoassay; Biospecific binding assay; Materials therefor involving antibody fragments
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/68Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving proteins, peptides or amino acids
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/30Immunoglobulins specific features characterized by aspects of specificity or valency
    • C07K2317/34Identification of a linear epitope shorter than 20 amino acid residues or of a conformational epitope defined by amino acid residues
    • CCHEMISTRY; METALLURGY
    • C12BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12YENZYMES
    • C12Y502/00Cis-trans-isomerases (5.2)
    • C12Y502/01Cis-trans-Isomerases (5.2.1)
    • C12Y502/01008Peptidylprolyl isomerase (5.2.1.8), i.e. cyclophilin
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N2333/00Assays involving biological materials from specific organisms or of a specific nature
    • G01N2333/90Enzymes; Proenzymes
    • G01N2333/99Isomerases (5.)

Abstract

a presente invenção proporciona métodos para a produção de polipeptídeo de peptidil-prolil cis-trans isomerase (fkpa) tipo fkbp com níveis muito elevados de pureza. também são fornecidos fkpa ultrapuros e métodos de uso dos mesmos, por exemplo, para uso em imunoensaios para mostrar a remoção de fkpa de produtos biológicos produzidos em bactérias. além disso, a presente invenção proporciona métodos para purificar polipeptídeos (por exemplo, anticorpos multiespecíficos) produzidos em bactérias que sobre-expressam uma ou mais chaperonas. os métodos incluem cromatografia de afinidade, cromatografia em modo misto e cromatografia de interação hidrofóbica. em alguns aspectos, a invenção proporciona composições de polipeptídeo (por exemplo, anticorpos multiespecíficos) que são essencialmente isentos de impurezas específicas do produto.
BR112018003127A 2015-08-20 2016-08-19 purificação de fkpa e usos do mesmo para produzir polipeptídeos recombinantes BR112018003127A2 (pt)

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
US201562207908P 2015-08-20 2015-08-20
US201562207910P 2015-08-20 2015-08-20
US201562210378P 2015-08-26 2015-08-26
PCT/US2016/047912 WO2017031476A2 (en) 2015-08-20 2016-08-19 Purification of fkpa and uses thereof for producing recombinant polypeptides

Publications (1)

Publication Number Publication Date
BR112018003127A2 true BR112018003127A2 (pt) 2018-09-25

Family

ID=58052052

Family Applications (1)

Application Number Title Priority Date Filing Date
BR112018003127A BR112018003127A2 (pt) 2015-08-20 2016-08-19 purificação de fkpa e usos do mesmo para produzir polipeptídeos recombinantes

Country Status (13)

Country Link
US (1) US20180327446A1 (pt)
EP (1) EP3337819B1 (pt)
JP (2) JP7091238B2 (pt)
KR (1) KR20180048731A (pt)
CN (1) CN108473558A (pt)
AU (1) AU2016308383A1 (pt)
BR (1) BR112018003127A2 (pt)
CA (1) CA2995385A1 (pt)
HK (1) HK1259368A1 (pt)
IL (2) IL257400A (pt)
MX (1) MX2018002068A (pt)
TW (1) TW201718623A (pt)
WO (1) WO2017031476A2 (pt)

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US9458450B2 (en) 2012-03-15 2016-10-04 Flodesign Sonics, Inc. Acoustophoretic separation technology using multi-dimensional standing waves
CN105939767B (zh) 2014-01-08 2018-04-06 弗洛设计声能学公司 具有双声电泳腔的声电泳装置
US11377651B2 (en) 2016-10-19 2022-07-05 Flodesign Sonics, Inc. Cell therapy processes utilizing acoustophoresis
US11708572B2 (en) 2015-04-29 2023-07-25 Flodesign Sonics, Inc. Acoustic cell separation techniques and processes
US11459540B2 (en) 2015-07-28 2022-10-04 Flodesign Sonics, Inc. Expanded bed affinity selection
US11474085B2 (en) 2015-07-28 2022-10-18 Flodesign Sonics, Inc. Expanded bed affinity selection
US11214789B2 (en) 2016-05-03 2022-01-04 Flodesign Sonics, Inc. Concentration and washing of particles with acoustics
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AU2018385759B2 (en) 2017-12-14 2021-10-21 Flodesign Sonics, Inc. Acoustic transducer driver and controller
WO2019129877A1 (en) * 2017-12-29 2019-07-04 F. Hoffmann-La Roche Ag Process for providing pegylated protein composition
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KR20210075101A (ko) * 2018-09-25 2021-06-22 아이크노스 사이언스 에스. 아. 생물학적 샘플에서의 항체 정량법
CN114409798A (zh) * 2019-02-14 2022-04-29 美勒斯公司 制备包含两种或更多种抗体的组合物
EP3942079A1 (en) 2019-03-18 2022-01-26 Bio-Rad ABD Serotec GmbH Protection of spytag-containing periplasmic fusion proteins from protease tsp and ompt degradation
CA3137116A1 (en) * 2019-05-03 2020-11-12 Genentech, Inc. Methods of reducing the enzymatic hydrolysis activity rate in a composition obtained from a purification platform
KR20220122678A (ko) * 2019-12-20 2022-09-02 머크 샤프 앤드 돔 엘엘씨 엔테로바이러스의 정제된 조성물 및 글루타티온 친화성 크로마토그래피를 이용한 정제 방법
US20230357315A1 (en) * 2020-03-11 2023-11-09 Dr. Reddy's Laboratories Limited METHOD OF PURIFYING AN Fc-FUSION PROTEIN

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Also Published As

Publication number Publication date
HK1259368A1 (zh) 2019-11-29
MX2018002068A (es) 2018-06-06
IL257400A (en) 2018-04-30
US20180327446A1 (en) 2018-11-15
TW201718623A (zh) 2017-06-01
KR20180048731A (ko) 2018-05-10
AU2016308383A1 (en) 2018-03-15
EP3337819A2 (en) 2018-06-27
CA2995385A1 (en) 2017-02-23
JP2022062046A (ja) 2022-04-19
JP7091238B2 (ja) 2022-06-27
IL288205A (en) 2022-01-01
WO2017031476A2 (en) 2017-02-23
JP2018533355A (ja) 2018-11-15
EP3337819B1 (en) 2024-02-21
EP3337819C0 (en) 2024-02-21
WO2017031476A3 (en) 2017-04-13
CN108473558A (zh) 2018-08-31

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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.

B07E Notification of approval relating to section 229 industrial property law [chapter 7.5 patent gazette]
B06U Preliminary requirement: requests with searches performed by other patent offices: procedure suspended [chapter 6.21 patent gazette]
B08F Application dismissed because of non-payment of annual fees [chapter 8.6 patent gazette]

Free format text: REFERENTE A 7A 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 2736 DE 13-06-2023 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.