CN112770775A - 色氨酸衍生物和l-蛋氨酸用于蛋白制剂的用途 - Google Patents

色氨酸衍生物和l-蛋氨酸用于蛋白制剂的用途 Download PDF

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Publication number
CN112770775A
CN112770775A CN201980064230.5A CN201980064230A CN112770775A CN 112770775 A CN112770775 A CN 112770775A CN 201980064230 A CN201980064230 A CN 201980064230A CN 112770775 A CN112770775 A CN 112770775A
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China
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antibody
formulation
methionine
nat
polypeptide
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Pending
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CN201980064230.5A
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English (en)
Chinese (zh)
Inventor
C·索尔兹伯里
V·夏尔马
S·阿拉瓦塔姆
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F Hoffmann La Roche AG
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F Hoffmann La Roche AG
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Publication of CN112770775A publication Critical patent/CN112770775A/zh
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K39/395—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • A61K39/39591—Stabilisation, fragmentation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/20—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing sulfur, e.g. dimethyl sulfoxide [DMSO], docusate, sodium lauryl sulfate or aminosulfonic acids
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/22—Heterocyclic compounds, e.g. ascorbic acid, tocopherol or pyrrolidones
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/08—Solutions
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
    • C07K16/42—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against immunoglobulins
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/20—Immunoglobulins specific features characterized by taxonomic origin
    • C07K2317/24—Immunoglobulins specific features characterized by taxonomic origin containing regions, domains or residues from different species, e.g. chimeric, humanized or veneered
    • 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
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/50—Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/52—Constant or Fc region; Isotype
    • C07K2317/524—CH2 domain
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/50—Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/52—Constant or Fc region; Isotype
    • C07K2317/526—CH3 domain
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/50—Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/56—Immunoglobulins specific features characterized by immunoglobulin fragments variable (Fv) region, i.e. VH and/or VL
    • C07K2317/565—Complementarity determining region [CDR]

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Immunology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Organic Chemistry (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Microbiology (AREA)
  • Mycology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Molecular Biology (AREA)
  • Genetics & Genomics (AREA)
  • Biophysics (AREA)
  • Biochemistry (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Medicinal Preparation (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Peptides Or Proteins (AREA)
CN201980064230.5A 2018-08-08 2019-08-07 色氨酸衍生物和l-蛋氨酸用于蛋白制剂的用途 Pending CN112770775A (zh)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US201862716239P 2018-08-08 2018-08-08
US62/716,239 2018-08-08
PCT/US2019/045420 WO2020033485A1 (en) 2018-08-08 2019-08-07 Use of tryptophan derivatives and l-methionine for protein formulation

Publications (1)

Publication Number Publication Date
CN112770775A true CN112770775A (zh) 2021-05-07

Family

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Family Applications (1)

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CN201980064230.5A Pending CN112770775A (zh) 2018-08-08 2019-08-07 色氨酸衍生物和l-蛋氨酸用于蛋白制剂的用途

Country Status (14)

Country Link
US (1) US20210155715A1 (https=)
EP (1) EP3833389A1 (https=)
JP (1) JP7542521B2 (https=)
KR (1) KR102898177B1 (https=)
CN (1) CN112770775A (https=)
AR (1) AR115925A1 (https=)
AU (1) AU2019319822B2 (https=)
BR (1) BR112021002130A2 (https=)
CA (1) CA3106537A1 (https=)
IL (1) IL280525B2 (https=)
MX (1) MX2021001453A (https=)
SG (1) SG11202100601TA (https=)
TW (1) TW202019478A (https=)
WO (1) WO2020033485A1 (https=)

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN103599541A (zh) * 2008-09-10 2014-02-26 弗·哈夫曼-拉罗切有限公司 用于防止蛋白质氧化降解的组合物和方法
CN104968362A (zh) * 2013-03-13 2015-10-07 霍夫曼-拉罗奇有限公司 氧化降低的配制剂
WO2017117304A1 (en) * 2015-12-30 2017-07-06 Genentech, Inc. Use of tryptophan derivatives for protein formulations

Family Cites Families (73)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
USRE30985E (en) 1978-01-01 1982-06-29 Serum-free cell culture media
FR2413974A1 (fr) 1978-01-06 1979-08-03 David Bernard Sechoir pour feuilles imprimees par serigraphie
US4419446A (en) 1980-12-31 1983-12-06 The United States Of America As Represented By The Department Of Health And Human Services Recombinant DNA process utilizing a papilloma virus DNA as a vector
NZ201705A (en) 1981-08-31 1986-03-14 Genentech Inc Recombinant dna method for production of hepatitis b surface antigen in yeast
US4601978A (en) 1982-11-24 1986-07-22 The Regents Of The University Of California Mammalian metallothionein promoter system
US4560655A (en) 1982-12-16 1985-12-24 Immunex Corporation Serum-free cell culture medium and process for making same
US4657866A (en) 1982-12-21 1987-04-14 Sudhir Kumar Serum-free, synthetic, completely chemically defined tissue culture media
US4816567A (en) 1983-04-08 1989-03-28 Genentech, Inc. Recombinant immunoglobin preparations
DD266710A3 (de) 1983-06-06 1989-04-12 Ve Forschungszentrum Biotechnologie Verfahren zur biotechnischen Herstellung van alkalischer Phosphatase
US4767704A (en) 1983-10-07 1988-08-30 Columbia University In The City Of New York Protein-free culture medium
US4965199A (en) 1984-04-20 1990-10-23 Genentech, Inc. Preparation of functional human factor VIII in mammalian cells using methotrexate based selection
US4879231A (en) 1984-10-30 1989-11-07 Phillips Petroleum Company Transformation of yeasts of the genus pichia
GB8516415D0 (en) 1985-06-28 1985-07-31 Celltech Ltd Culture of animal cells
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
US4927762A (en) 1986-04-01 1990-05-22 Cell Enterprises, Inc. Cell culture medium with antioxidant
GB8610600D0 (en) 1986-04-30 1986-06-04 Novo Industri As Transformation of trichoderma
AU632065B2 (en) 1988-09-23 1992-12-17 Novartis Vaccines And Diagnostics, Inc. Cell culture medium for enhanced cell growth, culture longevity and product expression
GB8823869D0 (en) 1988-10-12 1988-11-16 Medical Res Council Production of antibodies
EP0368684B2 (en) 1988-11-11 2004-09-29 Medical Research Council Cloning immunoglobulin variable domain sequences.
FR2646437B1 (fr) 1989-04-28 1991-08-30 Transgene Sa Nouvelles sequences d'adn, leur application en tant que sequence codant pour un peptide signal pour la secretion de proteines matures par des levures recombinantes, cassettes d'expression, levures transformees et procede de preparation de proteines correspondant
EP0402226A1 (en) 1989-06-06 1990-12-12 Institut National De La Recherche Agronomique Transformation vectors for yeast yarrowia
DE3920358A1 (de) 1989-06-22 1991-01-17 Behringwerke Ag Bispezifische und oligospezifische, mono- und oligovalente antikoerperkonstrukte, ihre herstellung und verwendung
ES2096590T3 (es) 1989-06-29 1997-03-16 Medarex Inc Reactivos biespecificos para la terapia del sida.
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
EP1690934A3 (en) 1990-01-12 2008-07-30 Abgenix, Inc. Generation of xenogeneic antibodies
US6075181A (en) 1990-01-12 2000-06-13 Abgenix, Inc. Human antibodies derived from immunized xenomice
US5661016A (en) 1990-08-29 1997-08-26 Genpharm International Inc. Transgenic non-human animals capable of producing heterologous antibodies of various isotypes
US5633425A (en) 1990-08-29 1997-05-27 Genpharm International, Inc. Transgenic non-human animals capable of producing heterologous antibodies
ATE300615T1 (de) 1990-08-29 2005-08-15 Genpharm Int Transgene mäuse fähig zur produktion heterologer antikörper
US5625126A (en) 1990-08-29 1997-04-29 Genpharm International, Inc. Transgenic non-human animals for producing heterologous antibodies
US5545806A (en) 1990-08-29 1996-08-13 Genpharm International, Inc. Ransgenic non-human animals for producing heterologous antibodies
US5122469A (en) 1990-10-03 1992-06-16 Genentech, Inc. Method for culturing Chinese hamster ovary cells to improve production of recombinant proteins
CA2405246A1 (en) 1990-12-03 1992-06-11 Genentech, Inc. Enrichment method for variant proteins with alterred binding properties
US5571894A (en) 1991-02-05 1996-11-05 Ciba-Geigy Corporation Recombinant antibodies specific for a growth factor receptor
EP0586505A1 (en) 1991-05-14 1994-03-16 Repligen Corporation Heteroconjugate antibodies for treatment of hiv infection
GB9114948D0 (en) 1991-07-11 1991-08-28 Pfizer Ltd Process for preparing sertraline intermediates
WO1993006217A1 (en) 1991-09-19 1993-04-01 Genentech, Inc. EXPRESSION IN E. COLI OF ANTIBODY FRAGMENTS HAVING AT LEAST A CYSTEINE PRESENT AS A FREE THIOL, USE FOR THE PRODUCTION OF BIFUNCTIONAL F(ab')2 ANTIBODIES
AU665025B2 (en) 1991-09-23 1995-12-14 Cambridge Antibody Technology Limited Production of chimeric antibodies - a combinatorial approach
FI941572L (fi) 1991-10-07 1994-05-27 Oncologix Inc Anti-erbB-2-monoklonaalisten vasta-aineiden yhdistelmä ja käyttömenetelmä
WO1993008829A1 (en) 1991-11-04 1993-05-13 The Regents Of The University Of California Compositions that mediate killing of hiv-infected cells
US5667988A (en) 1992-01-27 1997-09-16 The Scripps Research Institute Methods for producing antibody libraries using universal or randomized immunoglobulin light chains
AU675929B2 (en) 1992-02-06 1997-02-27 Curis, Inc. Biosynthetic binding protein for cancer marker
EP0656064B1 (en) 1992-08-17 1997-03-05 Genentech, Inc. Bispecific immunoadhesins
MD1367C2 (ro) 1992-11-13 2000-11-30 Idec Pharmaceuticals Corporation Metode de tratament al limfomului celulelor B, anticorpi anti-CD20, hibridom.
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
US5641870A (en) 1995-04-20 1997-06-24 Genentech, Inc. Low pH hydrophobic interaction chromatography for antibody purification
US5869046A (en) 1995-04-14 1999-02-09 Genentech, Inc. Altered polypeptides with increased half-life
CA2219361C (en) 1995-04-27 2012-02-28 Abgenix, Inc. Human antibodies derived from immunized xenomice
EP0823941A4 (en) 1995-04-28 2001-09-19 Abgenix Inc HUMAN ANTIBODIES DERIVED FROM IMMUNIZED XENO MOUSES
ATE441476T1 (de) 1996-08-30 2009-09-15 Upfront Chromatography As Isolierung von immunoglobulinen
EP1500329B1 (en) 1996-12-03 2012-03-21 Amgen Fremont Inc. Human antibodies that specifically bind human TNF alpha
US20080318254A9 (en) 1997-03-10 2008-12-25 The Regents Of The University Of California PSCA antibodies and hybridomas producing them
JP4213224B2 (ja) 1997-05-02 2009-01-21 ジェネンテック，インコーポレーテッド ヘテロマルチマー及び共通成分を有する多重特異性抗体の製造方法
US20020173629A1 (en) 1997-05-05 2002-11-21 Aya Jakobovits Human monoclonal antibodies to epidermal growth factor receptor
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
ES2375931T3 (es) 1997-12-05 2012-03-07 The Scripps Research Institute Humanización de anticuerpo murino.
DK1167537T3 (da) 1999-03-30 2008-11-10 Japan Tobacco Inc Fremgangsmåde til fremstilling af et monoklonalt antistof
CN100427603C (zh) 1999-10-04 2008-10-22 麦迪卡格公司 调控外源基因转录的方法
US7125978B1 (en) 1999-10-04 2006-10-24 Medicago Inc. Promoter for regulating expression of foreign genes
WO2002092017A2 (en) 2001-05-16 2002-11-21 Albert Einstein College Of Medicine Of Yeshiva University Human antipneumococcal antibodies from non-human animals
IL160358A0 (en) 2001-08-23 2004-07-25 Genmab As Human antibodies specific for interleukin 15 (il-15)
AU2004205898B2 (en) 2003-01-17 2009-11-19 The Research Foundation Of State University Of New York Pancreatic cancer associated antigen, antibody thereto, and diagnostic and treatment methods
US20060104968A1 (en) 2003-03-05 2006-05-18 Halozyme, Inc. Soluble glycosaminoglycanases and methods of preparing and using soluble glycosaminogly ycanases
US7871607B2 (en) 2003-03-05 2011-01-18 Halozyme, Inc. Soluble glycosaminoglycanases and methods of preparing and using soluble glycosaminoglycanases
JP4999158B2 (ja) 2003-05-21 2012-08-15 メダレツクス・インコーポレーテツド 炭疽菌（ｂａｃｈｉｌｌｕｓａｎｔｈｒａｃｉｓ）の感染防御抗原に対するヒトモノクローナル抗体
CN102946906B (zh) 2010-04-23 2015-07-15 弗·哈夫曼-拉罗切有限公司 生产异源多聚体蛋白质
PL2968467T3 (pl) * 2013-03-13 2020-10-19 F. Hoffmann-La Roche Ag Preparaty o zmniejszonym utlenianiu
AR095398A1 (es) * 2013-03-13 2015-10-14 Genentech Inc Formulaciones con oxidación reducida

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN103599541A (zh) * 2008-09-10 2014-02-26 弗·哈夫曼-拉罗切有限公司 用于防止蛋白质氧化降解的组合物和方法
CN104968362A (zh) * 2013-03-13 2015-10-07 霍夫曼-拉罗奇有限公司 氧化降低的配制剂
WO2017117304A1 (en) * 2015-12-30 2017-07-06 Genentech, Inc. Use of tryptophan derivatives for protein formulations
US20170239355A1 (en) * 2015-12-30 2017-08-24 Genentech, Inc. Use of tryptophan derivatives for protein formulations

Non-Patent Citations (4)

* Cited by examiner, † Cited by third party
Title
ALEXANDER JARASCH: "Developability Assessment During the Selection of Novel Therapeutic Antibodies", 《JOURNAL OF PHARMACEUTICAL SCIENCES》, vol. 104, no. 6, pages 1 - 6 *
GEORGEEN GAZA-BULSECO: "Effect of methionine oxidation of a recombinant monoclonal antibody on the binding affinity to protein A and protein G", 《JOURNAL OF CHROMATOGRAPHY B》, vol. 870, no. 2008, pages 55 - 62, XP022796992, DOI: 10.1016/j.jchromb.2008.05.045 *
JAN STRACKE: "A novel approach to investigate the effect of methionine oxidation on pharmacokinetic properties of therapeutic antibodies", 《MABS》, vol. 6, no. 5, pages 1229 - 1242, XP055266985, DOI: 10.4161/mabs.29601 *
XANTHE M.LAM: "Antioxidants for prevention of methionine oxidation in recombinant monoclonal antibody", 《JOURNAL OF PHARMACEUTICAL SCIENCE》, vol. 86, no. 11, pages 1250 - 1255, XP008038003, DOI: 10.1021/js970143s *

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CA3106537A1 (en) 2020-02-13
MX2021001453A (es) 2021-04-12
US20210155715A1 (en) 2021-05-27
KR20210042936A (ko) 2021-04-20
WO2020033485A1 (en) 2020-02-13
IL280525B2 (en) 2024-11-01
IL280525A (en) 2021-03-01
JP7542521B2 (ja) 2024-08-30
BR112021002130A2 (pt) 2021-05-04
AR115925A1 (es) 2021-03-10
EP3833389A1 (en) 2021-06-16
SG11202100601TA (en) 2021-02-25
KR102898177B1 (ko) 2025-12-10
AU2019319822A1 (en) 2021-03-18
AU2019319822B2 (en) 2026-04-16
TW202019478A (zh) 2020-06-01
JP2021533149A (ja) 2021-12-02
IL280525B1 (en) 2024-07-01

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