BR112019010294A2 - método para a produção enzimática de um anticorpo, anticorpo e formulação farmacêutica - Google Patents

método para a produção enzimática de um anticorpo, anticorpo e formulação farmacêutica

Info

Publication number
BR112019010294A2
BR112019010294A2 BR112019010294A BR112019010294A BR112019010294A2 BR 112019010294 A2 BR112019010294 A2 BR 112019010294A2 BR 112019010294 A BR112019010294 A BR 112019010294A BR 112019010294 A BR112019010294 A BR 112019010294A BR 112019010294 A2 BR112019010294 A2 BR 112019010294A2
Authority
BR
Brazil
Prior art keywords
antibody
glycosylation
region
enzyme
modified
Prior art date
Application number
BR112019010294A
Other languages
English (en)
Inventor
Walch Heiko
Grunert Ingrid
Thomann Marco
Freiherr Von Roman Matthias
Falkenstein Roberto
Malik Sebastian
Dams Thomas
Original Assignee
Hoffmann La Roche
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 Hoffmann La Roche filed Critical Hoffmann La Roche
Publication of BR112019010294A2 publication Critical patent/BR112019010294A2/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
    • C07K1/18Ion-exchange chromatography
    • CCHEMISTRY; METALLURGY
    • C12BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12PFERMENTATION OR ENZYME-USING PROCESSES TO SYNTHESISE A DESIRED CHEMICAL COMPOUND OR COMPOSITION OR TO SEPARATE OPTICAL ISOMERS FROM A RACEMIC MIXTURE
    • C12P21/00Preparation of peptides or proteins
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K16/00Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • 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
    • 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
    • C12N9/10Transferases (2.)
    • C12N9/1048Glycosyltransferases (2.4)
    • C12N9/1051Hexosyltransferases (2.4.1)
    • 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
    • C12N9/10Transferases (2.)
    • C12N9/1048Glycosyltransferases (2.4)
    • C12N9/1081Glycosyltransferases (2.4) transferring other glycosyl groups (2.4.99)
    • CCHEMISTRY; METALLURGY
    • C12BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12PFERMENTATION OR ENZYME-USING PROCESSES TO SYNTHESISE A DESIRED CHEMICAL COMPOUND OR COMPOSITION OR TO SEPARATE OPTICAL ISOMERS FROM A RACEMIC MIXTURE
    • C12P21/00Preparation of peptides or proteins
    • C12P21/005Glycopeptides, glycoproteins
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K45/00Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
    • A61K45/06Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
    • CCHEMISTRY; METALLURGY
    • C12BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12YENZYMES
    • C12Y204/00Glycosyltransferases (2.4)
    • C12Y204/01Hexosyltransferases (2.4.1)
    • C12Y204/01038Beta-N-acetylglucosaminylglycopeptide beta-1,4-galactosyltransferase (2.4.1.38)
    • CCHEMISTRY; METALLURGY
    • C12BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12YENZYMES
    • C12Y204/00Glycosyltransferases (2.4)
    • C12Y204/99Glycosyltransferases (2.4) transferring other glycosyl groups (2.4.99)
    • C12Y204/99003Alpha-N-acetylgalactosaminide alpha-2,6-sialyltransferase (2.4.99.3)

Landscapes

  • Chemical & Material Sciences (AREA)
  • Organic Chemistry (AREA)
  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Genetics & Genomics (AREA)
  • Engineering & Computer Science (AREA)
  • Zoology (AREA)
  • Wood Science & Technology (AREA)
  • General Health & Medical Sciences (AREA)
  • Biochemistry (AREA)
  • Molecular Biology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Medicinal Chemistry (AREA)
  • General Engineering & Computer Science (AREA)
  • Microbiology (AREA)
  • Biotechnology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Biophysics (AREA)
  • General Chemical & Material Sciences (AREA)
  • Immunology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Biomedical Technology (AREA)
  • Analytical Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Preparation Of Compounds By Using Micro-Organisms (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Peptides Or Proteins (AREA)

Abstract

a presente invenção se refere a um método para a produção enzimática de um anticorpo com uma glicosilação modificada na região de fc que compreende as etapas de incubação do anticorpo monoclonal unido ao ligante de afinidade de ligação de cadeia leve de anticorpo com uma glicosilação na região de fc com uma primeira enzima para um tempo suficiente e sob condições adequadas para a modificação da glicosilação da região de fc, recuperando o anticorpo a partir do ligante de afinidade da cadeia leve do anticorpo, incubando o anticorpo recuperado em solução com uma segunda enzima durante um tempo suficiente e sob condições adequadas para a modificação da glicosilação da região de fc para uma forma definida, separando o anticorpo com a glicosilação modificada na região de fc da segunda enzima em uma cromatografia de troca catiônica e, por conseguinte, produzindo o anticorpo com uma glicosilação modificada na região de fc.
BR112019010294A 2016-12-21 2017-12-19 método para a produção enzimática de um anticorpo, anticorpo e formulação farmacêutica BR112019010294A2 (pt)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
EP16205585 2016-12-21
EP17157006 2017-02-20
PCT/EP2017/083431 WO2018114879A1 (en) 2016-12-21 2017-12-19 Method for in vitro glycoengineering of antibodies

Publications (1)

Publication Number Publication Date
BR112019010294A2 true BR112019010294A2 (pt) 2019-09-03

Family

ID=60942993

Family Applications (1)

Application Number Title Priority Date Filing Date
BR112019010294A BR112019010294A2 (pt) 2016-12-21 2017-12-19 método para a produção enzimática de um anticorpo, anticorpo e formulação farmacêutica

Country Status (12)

Country Link
US (1) US11767342B2 (pt)
EP (1) EP3559249A1 (pt)
JP (1) JP6952115B2 (pt)
KR (1) KR102293106B1 (pt)
CN (2) CN117887794A (pt)
AU (1) AU2017381657B2 (pt)
BR (1) BR112019010294A2 (pt)
CA (1) CA3045970A1 (pt)
IL (1) IL267352B2 (pt)
MX (1) MX2019006123A (pt)
TW (1) TWI781973B (pt)
WO (1) WO2018114879A1 (pt)

Families Citing this family (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
MA53123A (fr) 2018-07-13 2021-05-19 Genmab As Thérapie à médiation par trogocytose utilisant des anticorps cd38
SG11202012993SA (en) 2018-07-13 2021-02-25 Genmab As Variants of cd38 antibody and uses thereof
CN114980927A (zh) 2020-01-16 2022-08-30 健玛保 Cd38抗体的配制剂及其用途
KR20240051280A (ko) 2021-09-06 2024-04-19 젠맵 에이/에스 Cd27과 결합할 수 있는 항체, 그의 변이체 및 그의 용도

Family Cites Families (73)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4816567A (en) 1983-04-08 1989-03-28 Genentech, Inc. Recombinant immunoglobin preparations
US4676980A (en) 1985-09-23 1987-06-30 The United States Of America As Represented By The Secretary Of The Department Of Health And Human Services Target specific cross-linked heteroantibodies
US6548640B1 (en) 1986-03-27 2003-04-15 Btg International Limited Altered antibodies
WO1988007089A1 (en) 1987-03-18 1988-09-22 Medical Research Council Altered antibodies
US5202238A (en) 1987-10-27 1993-04-13 Oncogen Production of chimeric antibodies by homologous recombination
US5204244A (en) 1987-10-27 1993-04-20 Oncogen Production of chimeric antibodies by homologous recombination
US5959177A (en) 1989-10-27 1999-09-28 The Scripps Research Institute Transgenic plants expressing assembled secretory antibodies
US6150584A (en) 1990-01-12 2000-11-21 Abgenix, Inc. Human antibodies derived from immunized xenomice
US6075181A (en) 1990-01-12 2000-06-13 Abgenix, Inc. Human antibodies derived from immunized xenomice
US5770429A (en) 1990-08-29 1998-06-23 Genpharm International, Inc. Transgenic non-human animals capable of producing heterologous antibodies
CA2405246A1 (en) 1990-12-03 1992-06-11 Genentech, Inc. Enrichment method for variant proteins with alterred binding properties
AU668505B2 (en) 1991-03-18 1996-05-09 Scripps Research Institute, The Oligosaccharide enzyme substrates and inhibitors: methods and compositions
CA2103059C (en) 1991-06-14 2005-03-22 Paul J. Carter Method for making humanized antibodies
CA2116774C (en) 1991-09-19 2003-11-11 Paul J. Carter Expression in e. coli antibody fragments having at least a cysteine present as a free thiol. use for the production of bifunctional f(ab') 2 antibodies
WO1993008829A1 (en) 1991-11-04 1993-05-13 The Regents Of The University Of California Compositions that mediate killing of hiv-infected cells
US5789199A (en) 1994-11-03 1998-08-04 Genentech, Inc. Process for bacterial production of polypeptides
US5840523A (en) 1995-03-01 1998-11-24 Genetech, Inc. Methods and compositions for secretion of heterologous polypeptides
US5731168A (en) 1995-03-01 1998-03-24 Genentech, Inc. Method for making heteromultimeric polypeptides
US6267958B1 (en) 1995-07-27 2001-07-31 Genentech, Inc. Protein formulation
AU5874798A (en) 1997-01-31 1998-08-25 Biovation Limited Vaccination methods and molecules
JP2002512624A (ja) 1997-05-21 2002-04-23 バイオベーション リミテッド 非免疫原性タンパク質の製造方法
US6171586B1 (en) 1997-06-13 2001-01-09 Genentech, Inc. Antibody formulation
US6040498A (en) 1998-08-11 2000-03-21 North Caroline State University Genetically engineered duckweed
US6610833B1 (en) 1997-11-24 2003-08-26 The Institute For Human Genetics And Biochemistry Monoclonal human natural antibodies
DK1034298T3 (da) 1997-12-05 2012-01-30 Scripps Research Inst Humanisering af murint antistof
EP1051432B1 (en) 1998-12-08 2007-01-24 Biovation Limited Method for reducing immunogenicity of proteins
DE60022369T2 (de) 1999-10-04 2006-05-18 Medicago Inc., Sainte Foy Verfahren zur regulation der transkription von fremden genen in gegenwart von stickstoff
US7125978B1 (en) 1999-10-04 2006-10-24 Medicago Inc. Promoter for regulating expression of foreign genes
US20030180714A1 (en) 1999-12-15 2003-09-25 Genentech, Inc. Shotgun scanning
AU2001247616B2 (en) 2000-04-11 2007-06-14 Genentech, Inc. Multivalent antibodies and uses therefor
US6596541B2 (en) 2000-10-31 2003-07-22 Regeneron Pharmaceuticals, Inc. Methods of modifying eukaryotic cells
US7041870B2 (en) 2000-11-30 2006-05-09 Medarex, Inc. Transgenic transchromosomal rodents for making human antibodies
EP1513879B1 (en) 2002-06-03 2018-08-22 Genentech, Inc. Synthetic antibody phage libraries
US20050079574A1 (en) 2003-01-16 2005-04-14 Genentech, Inc. Synthetic antibody phage libraries
US7871607B2 (en) 2003-03-05 2011-01-18 Halozyme, Inc. Soluble glycosaminoglycanases and methods of preparing and using soluble glycosaminoglycanases
US20060104968A1 (en) 2003-03-05 2006-05-18 Halozyme, Inc. Soluble glycosaminoglycanases and methods of preparing and using soluble glycosaminogly ycanases
EP1460425A1 (en) 2003-03-17 2004-09-22 Boehringer Mannheim Gmbh Deglycosylated enzymes for conjugates
DE602004015620D1 (de) 2003-07-28 2008-09-18 Janssen Pharmaceutica Nv Benzimidazol-, benzothiazol- und benzoxazolderivate und deren verwendung als lta4h-modulatoren
AU2005230848B9 (en) 2004-03-31 2011-06-02 Genentech, Inc. Humanized anti-TGF-beta antibodies
US7785903B2 (en) 2004-04-09 2010-08-31 Genentech, Inc. Variable domain library and uses
US20060127950A1 (en) 2004-04-15 2006-06-15 Massachusetts Institute Of Technology Methods and products related to the improved analysis of carbohydrates
US20060057638A1 (en) 2004-04-15 2006-03-16 Massachusetts Institute Of Technology Methods and products related to the improved analysis of carbohydrates
TWI380996B (zh) 2004-09-17 2013-01-01 Hoffmann La Roche 抗ox40l抗體
JO3000B1 (ar) 2004-10-20 2016-09-05 Genentech Inc مركبات أجسام مضادة .
AU2006265676B2 (en) 2005-06-30 2013-01-24 Centocor, Inc. Methods and compositions with enhanced therapeutic activity
EP2465870A1 (en) 2005-11-07 2012-06-20 Genentech, Inc. Binding polypeptides with diversified and consensus VH/VL hypervariable sequences
US20070237764A1 (en) 2005-12-02 2007-10-11 Genentech, Inc. Binding polypeptides with restricted diversity sequences
CA2651567A1 (en) 2006-05-09 2007-11-22 Genentech, Inc. Binding polypeptides with optimized scaffolds
TW200813086A (en) 2006-05-11 2008-03-16 Hoffmann La Roche Immunereconstituted mouse
CN101516388B (zh) * 2006-07-21 2012-10-31 诺和诺德公司 通过o-联糖基化序列的肽的糖基化
US10118970B2 (en) 2006-08-30 2018-11-06 Genentech, Inc. Multispecific antibodies
CN100592373C (zh) 2007-05-25 2010-02-24 群康科技(深圳)有限公司 液晶显示面板驱动装置及其驱动方法
EP2188382A1 (en) 2007-08-31 2010-05-26 F. Hoffmann-Roche AG Glycosylation profile analysis
US20090162359A1 (en) 2007-12-21 2009-06-25 Christian Klein Bivalent, bispecific antibodies
US8242247B2 (en) 2007-12-21 2012-08-14 Hoffmann-La Roche Inc. Bivalent, bispecific antibodies
US9266967B2 (en) 2007-12-21 2016-02-23 Hoffmann-La Roche, Inc. Bivalent, bispecific antibodies
US8227577B2 (en) 2007-12-21 2012-07-24 Hoffman-La Roche Inc. Bivalent, bispecific antibodies
DK2235064T3 (en) 2008-01-07 2016-01-11 Amgen Inc A process for the preparation of heterodimeric Fc molecules using electrostatic control effects
JP5647899B2 (ja) 2008-01-08 2015-01-07 ラツィオファルム ゲーエムベーハーratiopharm GmbH オリゴサッカリルトランスフェラーゼを使用するポリペプチドの複合糖質化
MX2011010159A (es) 2009-04-02 2011-10-17 Roche Glycart Ag Anticuerpos multiespecificos que comprenden anticuerpos de longitud completa y fragmentos fab de cadena sencilla.
JP5616428B2 (ja) 2009-04-07 2014-10-29 ロシュ グリクアート アクチェンゲゼルシャフト 三価の二重特異性抗体
EP2435473B1 (en) 2009-05-27 2013-10-02 F.Hoffmann-La Roche Ag Tri- or tetraspecific antibodies
US9676845B2 (en) 2009-06-16 2017-06-13 Hoffmann-La Roche, Inc. Bispecific antigen binding proteins
US8703132B2 (en) 2009-06-18 2014-04-22 Hoffmann-La Roche, Inc. Bispecific, tetravalent antigen binding proteins
CA2766839A1 (en) 2009-07-30 2011-02-03 F. Hoffmann-La Roche Ag Enzymatic antibody processing
ES2534936T3 (es) 2010-08-02 2015-04-30 Ratiopharm Gmbh Método para producir y purificar una sialiltransferasa soluble activa
AU2012351751B2 (en) 2011-10-19 2017-09-07 Novimmune S.A. Methods of purifying antibodies
CA2862925C (en) 2012-02-10 2020-01-21 University Of Maryland, Baltimore Chemoenzymatic glycoengineering of antibodies and fc fragments thereof
US9334319B2 (en) * 2012-04-20 2016-05-10 Abbvie Inc. Low acidic species compositions
WO2015123754A1 (en) * 2014-02-18 2015-08-27 The University Of Manitoba Methods to produce single glycoform antibodies
CN114181312A (zh) * 2014-09-10 2022-03-15 豪夫迈·罗氏有限公司 半乳糖改造的免疫球蛋白1抗体
UA124303C2 (uk) 2015-10-27 2021-08-25 Ф. Хоффманн-Ля Рош Аг Пептидні макроцикли проти acinetobacter baumannii
KR102317884B1 (ko) * 2016-12-21 2021-10-26 에프. 호프만-라 로슈 아게 항체의 시험관 내 당조작

Also Published As

Publication number Publication date
CN117887794A (zh) 2024-04-16
US11767342B2 (en) 2023-09-26
US20200165296A1 (en) 2020-05-28
JP6952115B2 (ja) 2021-10-20
CN110088292A (zh) 2019-08-02
IL267352B1 (en) 2023-06-01
CA3045970A1 (en) 2018-06-28
JP2020501581A (ja) 2020-01-23
KR102293106B1 (ko) 2021-08-24
IL267352B2 (en) 2023-10-01
KR20190082943A (ko) 2019-07-10
AU2017381657B2 (en) 2020-07-23
MX2019006123A (es) 2019-08-12
WO2018114879A1 (en) 2018-06-28
IL267352A (en) 2019-08-29
AU2017381657A1 (en) 2019-05-30
TW201837177A (zh) 2018-10-16
TWI781973B (zh) 2022-11-01
EP3559249A1 (en) 2019-10-30

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B07A Application suspended after technical examination (opinion) [chapter 7.1 patent gazette]