AU2016380988B2 - Formulations with reduced degradation of polysorbate - Google Patents

Formulations with reduced degradation of polysorbate Download PDF

Info

Publication number
AU2016380988B2
AU2016380988B2 AU2016380988A AU2016380988A AU2016380988B2 AU 2016380988 B2 AU2016380988 B2 AU 2016380988B2 AU 2016380988 A AU2016380988 A AU 2016380988A AU 2016380988 A AU2016380988 A AU 2016380988A AU 2016380988 B2 AU2016380988 B2 AU 2016380988B2
Authority
AU
Australia
Prior art keywords
formulation
polysorbate
antibody
months
cyclodextrin
Prior art date
Legal status (The legal status 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 status listed.)
Active
Application number
AU2016380988A
Other languages
English (en)
Other versions
AU2016380988A1 (en
Inventor
Brian Connolly
Lydia HAMBURG
Emily HOLZ
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Genentech Inc
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 AU2016380988A1 publication Critical patent/AU2016380988A1/en
Application granted granted Critical
Publication of AU2016380988B2 publication Critical patent/AU2016380988B2/en
Priority to AU2022256163A priority Critical patent/AU2022256163A1/en
Active legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Classifications

    • 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
    • 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
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
    • A61K47/40—Cyclodextrins; Derivatives thereof
    • 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
    • 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
    • A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • 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
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/42—Proteins; Polypeptides; Degradation products thereof; Derivatives thereof, e.g. albumin, gelatin or zein
    • 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
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • 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
    • A61K9/10—Dispersions; Emulsions
    • 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
    • C07K2317/55—Fab or Fab'

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Epidemiology (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Engineering & Computer Science (AREA)
  • Mycology (AREA)
  • Immunology (AREA)
  • Microbiology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Inorganic Chemistry (AREA)
  • General Chemical & Material Sciences (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Molecular Biology (AREA)
  • Biochemistry (AREA)
  • Dermatology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Dispersion Chemistry (AREA)
  • Medicinal Preparation (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
AU2016380988A 2015-12-30 2016-12-28 Formulations with reduced degradation of polysorbate Active AU2016380988B2 (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
AU2022256163A AU2022256163A1 (en) 2015-12-30 2022-10-20 Formulations with reduced degradation of polysorbate

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US201562272965P 2015-12-30 2015-12-30
US62/272,965 2015-12-30
PCT/US2016/069046 WO2017117311A1 (en) 2015-12-30 2016-12-28 Formulations with reduced degradation of polysorbate

Related Child Applications (1)

Application Number Title Priority Date Filing Date
AU2022256163A Division AU2022256163A1 (en) 2015-12-30 2022-10-20 Formulations with reduced degradation of polysorbate

Publications (2)

Publication Number Publication Date
AU2016380988A1 AU2016380988A1 (en) 2018-07-05
AU2016380988B2 true AU2016380988B2 (en) 2022-07-21

Family

ID=57868354

Family Applications (2)

Application Number Title Priority Date Filing Date
AU2016380988A Active AU2016380988B2 (en) 2015-12-30 2016-12-28 Formulations with reduced degradation of polysorbate
AU2022256163A Abandoned AU2022256163A1 (en) 2015-12-30 2022-10-20 Formulations with reduced degradation of polysorbate

Family Applications After (1)

Application Number Title Priority Date Filing Date
AU2022256163A Abandoned AU2022256163A1 (en) 2015-12-30 2022-10-20 Formulations with reduced degradation of polysorbate

Country Status (15)

Country Link
US (3) US10525137B2 (enExample)
EP (1) EP3397287B8 (enExample)
JP (2) JP7008023B2 (enExample)
KR (2) KR20250052501A (enExample)
CN (2) CN108472379B (enExample)
AU (2) AU2016380988B2 (enExample)
BR (1) BR112018010945A2 (enExample)
CA (1) CA3007419A1 (enExample)
ES (1) ES3038408T3 (enExample)
HR (1) HRP20250951T1 (enExample)
HU (1) HUE072357T2 (enExample)
IL (2) IL299759A (enExample)
PL (1) PL3397287T3 (enExample)
SG (1) SG11201804961UA (enExample)
WO (1) WO2017117311A1 (enExample)

Families Citing this family (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
AU2016380988B2 (en) 2015-12-30 2022-07-21 Genentech, Inc. Formulations with reduced degradation of polysorbate
IL277215B2 (en) 2018-03-14 2025-10-01 Boehringer Ingelheim Int Use of anti-IL-36R antibodies for the treatment of generalized pustular psoriasis
EP3560945A1 (en) 2018-04-27 2019-10-30 F. Hoffmann-La Roche AG Methods for purification of polypeptides using polysorbates
EP3934620A1 (en) 2019-03-05 2022-01-12 Regeneron Pharmaceuticals, Inc. Human serum albumin in formulations
EP3962924A1 (en) * 2019-05-03 2022-03-09 Genentech, Inc. Methods of reducing the enzymatic hydrolysis activity rate in a composition obtained from a purification platform
BR112021025558A2 (pt) 2019-06-17 2022-03-03 Intas Pharmaceuticals Ltd Formulação estável de cetrorelix e processo para a preparação de uma formulação estável
KR20220027940A (ko) * 2019-06-28 2022-03-08 제넨테크, 인크. 액체 단백질 제제의 안정화를 위한 조성물 및 방법
KR20220157386A (ko) * 2020-03-20 2022-11-29 글락소스미스클라인 인털렉츄얼 프로퍼티 디벨로프먼트 리미티드 폴리소르베이트의 검출 방법
AU2022420630A1 (en) 2021-12-20 2024-05-02 Boehringer Ingelheim International Gmbh Method for determining the degree of oxidative degradation of polysorbate 20 in aqueous formulations

Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2013164837A1 (en) * 2012-03-07 2013-11-07 Cadila Healthcare Limited Pharmaceutical formulations of tnf-alpha antibodies

Family Cites Families (129)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE266710C (enExample)
IL47062A (en) 1975-04-10 1979-07-25 Yeda Res & Dev Process for diminishing antigenicity of tissues to be usedas transplants by treatment with glutaraldehyde
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
US4665077A (en) 1979-03-19 1987-05-12 The Upjohn Company Method for treating rejection of organ or skin grafts with 6-aryl pyrimidine compounds
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
IL85035A0 (en) 1987-01-08 1988-06-30 Int Genetic Eng Polynucleotide molecule,a chimeric antibody with specificity for human b cell surface antigen,a process for the preparation and methods utilizing the same
DE3850542T2 (de) 1987-09-23 1994-11-24 Bristol Myers Squibb Co Antikörper-Heterokonjugate zur Töting von HIV-infizierten Zellen.
IL85746A (en) 1988-03-15 1994-05-30 Yeda Res & Dev Preparations comprising t-lymphocyte cells treated with 8-methoxypsoralen or cell membranes separated therefrom for preventing or treating autoimmune diseases
FI891226L (fi) 1988-04-28 1989-10-29 Univ Leland Stanford Junior Reseptordeterminanter i anti-t-celler foer behandling av autoimmunsjukdom.
EP0435911B1 (en) 1988-09-23 1996-03-13 Cetus Oncology Corporation Cell culture medium for enhanced cell growth, culture longevity and product expression
US5997856A (en) 1988-10-05 1999-12-07 Chiron Corporation Method and compositions for solubilization and stabilization of polypeptides, especially proteins
GB8823869D0 (en) 1988-10-12 1988-11-16 Medical Res Council Production of antibodies
WO1990005144A1 (en) 1988-11-11 1990-05-17 Medical Research Council Single domain ligands, receptors comprising said ligands, methods for their production, and use of said ligands and receptors
US5175384A (en) 1988-12-05 1992-12-29 Genpharm International Transgenic mice depleted in mature t-cells and methods for making transgenic mice
WO1990008187A1 (en) 1989-01-19 1990-07-26 Dana Farber Cancer Institute Soluble two domain cd2 protein
ES2062519T5 (es) 1989-03-21 2003-07-16 Immune Response Corp Inc Vacunacion y metodos contra enfermedades originadas a partir de respuestas patogenicas mediante poblaciones especificas de linfocitos t.
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
AU641673B2 (en) 1989-06-29 1993-09-30 Medarex, Inc. Bispecific reagents for aids therapy
EP0552142B2 (en) 1989-07-19 2003-12-17 Corporation Connetics T cell receptor peptides as therapeutics for autoimmune and malignant disease
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
ATE356869T1 (de) 1990-01-12 2007-04-15 Amgen Fremont Inc Bildung von xenogenen antikörpern
US6075181A (en) 1990-01-12 2000-06-13 Abgenix, Inc. Human antibodies derived from immunized xenomice
US5229275A (en) 1990-04-26 1993-07-20 Akzo N.V. In-vitro method for producing antigen-specific human monoclonal antibodies
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
US5633425A (en) 1990-08-29 1997-05-27 Genpharm International, Inc. Transgenic non-human animals capable of producing heterologous antibodies
CA2089661C (en) 1990-08-29 2007-04-03 Nils Lonberg Transgenic non-human animals capable of producing heterologous antibodies
US5661016A (en) 1990-08-29 1997-08-26 Genpharm International Inc. Transgenic non-human animals capable of producing heterologous antibodies of various isotypes
US5122469A (en) 1990-10-03 1992-06-16 Genentech, Inc. Method for culturing Chinese hamster ovary cells to improve production of recombinant proteins
WO1992009690A2 (en) 1990-12-03 1992-06-11 Genentech, Inc. Enrichment method for variant proteins with altered binding properties
US5571894A (en) 1991-02-05 1996-11-05 Ciba-Geigy Corporation Recombinant antibodies specific for a growth factor receptor
JPH06507398A (ja) 1991-05-14 1994-08-25 リプリジェン　コーポレーション Ｈｉｖ感染治療のための異種複合抗体
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
US5565332A (en) 1991-09-23 1996-10-15 Medical Research Council Production of chimeric antibodies - a combinatorial approach
FI941572A7 (fi) 1991-10-07 1994-05-27 Oncologix Inc Anti-erbB-2-monoklonaalisten vasta-aineiden yhdistelmä ja käyttömenete lmä
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
JPH08500962A (ja) 1992-02-06 1996-02-06 クリエイティブ バイオモレキュルズ，インコーポレイテッド 癌マーカー用生物合成結合蛋白質
ATE149570T1 (de) 1992-08-17 1997-03-15 Genentech Inc Bispezifische immunoadhesine
US5736137A (en) 1992-11-13 1998-04-07 Idec Pharmaceuticals Corporation Therapeutic application of chimeric and radiolabeled antibodies to human B lymphocyte restricted differentiation antigen for treatment of B cell lymphoma
EP1005870B1 (en) 1992-11-13 2009-01-21 Biogen Idec Inc. Therapeutic application of chimeric antibodies to human B lymphocyte restricted differentiation antigen for treatment of B cell lymphoma
DK0695169T3 (da) 1993-04-22 2003-03-17 Skyepharma Inc Multivesikulære liposomer med indkapslet cyclodextrin og farmakologisk aktive forbindelser samt fremgangsmåder til anvendelse af disse
US5595721A (en) 1993-09-16 1997-01-21 Coulter Pharmaceutical, Inc. Radioimmunotherapy of lymphoma using anti-CD20
JP3597239B2 (ja) * 1994-03-31 2004-12-02 ライオン株式会社 安定な点眼剤
US5789199A (en) 1994-11-03 1998-08-04 Genentech, Inc. Process for bacterial production of polypeptides
US5731168A (en) 1995-03-01 1998-03-24 Genentech, Inc. Method for making heteromultimeric polypeptides
US5840523A (en) 1995-03-01 1998-11-24 Genetech, Inc. Methods and compositions for secretion of heterologous 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
ATE390933T1 (de) 1995-04-27 2008-04-15 Amgen Fremont Inc Aus immunisierten xenomäusen stammende menschliche antikörper gegen il-8
AU2466895A (en) 1995-04-28 1996-11-18 Abgenix, Inc. Human antibodies derived from immunized xenomice
EP1666591B1 (en) 1995-06-29 2011-03-23 Immunex Corporation Cytokine that induces apoptosis
DE19544393A1 (de) 1995-11-15 1997-05-22 Hoechst Schering Agrevo Gmbh Synergistische herbizide Mischungen
US6030945A (en) 1996-01-09 2000-02-29 Genentech, Inc. Apo-2 ligand
JP4425994B2 (ja) 1996-08-30 2010-03-03 ウプフロント クロマトグラフィー アクティーゼルスカブ 免疫グロブリンの単離
EP2314625B1 (en) 1996-12-03 2014-05-07 Amgen Fremont Inc. Transgenic mammals having human Ig loci including plural VH and Vkappa regions and antibodies produced therefrom
US20080318254A9 (en) 1997-03-10 2008-12-25 The Regents Of The University Of California PSCA antibodies and hybridomas producing them
AU751659B2 (en) 1997-05-02 2002-08-22 Genentech Inc. A method for making multispecific antibodies having heteromultimeric and common components
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.
PT2180007E (pt) 1998-04-20 2013-11-25 Roche Glycart Ag Engenharia de glicosilação de anticorpos para melhorar a citotoxicidade celular dependente de anticorpos
JP2000226336A (ja) 1998-11-30 2000-08-15 Sankyo Co Ltd 免疫グロブリン製剤
WO2000058499A1 (fr) 1999-03-30 2000-10-05 Japan Tobacco Inc. Procede pour la production d'anticorps monoclonal
CN1245216C (zh) 1999-10-04 2006-03-15 希龙公司 稳定化的含多肽的液体药物组合物
ES2248127T3 (es) 1999-10-04 2006-03-16 Medicago Inc. Metodo para regular la transcripcion de genes foraneos en presencia de nigtrogeno.
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
US7321026B2 (en) 2001-06-27 2008-01-22 Skytech Technology Limited Framework-patched immunoglobulins
WO2003002152A2 (en) 2001-06-29 2003-01-09 Maxygen Aps Stabilized formulations of interferons with sulfoalkyl ether cyclodextrins
NZ603111A (en) 2001-08-03 2014-05-30 Roche Glycart Ag Antibody glycosylation variants having increased antibody-dependent cellular cytotoxicity
NZ531211A (en) 2001-08-23 2007-04-27 Genmad As Human antibodies specific for interleukin 15 (IL-15)
ES2326964T3 (es) 2001-10-25 2009-10-22 Genentech, Inc. Composiciones de glicoproteina.
US20040093621A1 (en) 2001-12-25 2004-05-13 Kyowa Hakko Kogyo Co., Ltd Antibody composition which specifically binds to CD20
CN100522999C (zh) 2002-02-14 2009-08-05 免疫医疗公司 抗cd20抗体及其融合蛋白和使用方法
JPWO2003085118A1 (ja) 2002-04-09 2005-08-11 協和醗酵工業株式会社 抗体組成物の製造方法
BR0309145A (pt) 2002-04-09 2005-02-01 Kyowa Hakko Kogyo Kk Células das quais o genoma é modificado
DE10228049A1 (de) 2002-06-24 2004-01-15 Merck Patent Gmbh Flüssige Zubereitung enthaltend Oligopeptide
ES2744275T3 (es) 2002-10-17 2020-02-24 Genmab As Anticuerpos monoclonales humanos contra CD20 para su uso en el tratamiento de esclerosis múltiple
DE60332957D1 (de) 2002-12-16 2010-07-22 Genentech Inc Immunoglobulinvarianten und deren verwendungen
AU2004206842A1 (en) 2003-01-14 2004-08-05 Teva Pharmaceutical Industries, Ltd. Parenteral formulations of peptides for the treatment of systemic lupus erythematosus
US20060258841A1 (en) 2003-01-17 2006-11-16 Josef Michl Pancreatic cancer associated antigen, antibody thereto, and diagnostic and treatment methods
US20050158303A1 (en) 2003-04-04 2005-07-21 Genentech, Inc. Methods of treating IgE-mediated disorders comprising the administration of high concentration anti-IgE antibody formulations
EP2335725B1 (en) 2003-04-04 2016-10-12 Genentech, Inc. High concentration antibody and protein formulations
NZ587776A (en) 2003-04-09 2012-03-30 Genentech Inc Therapy of autoimmune disease in a patient with an inadequate response to a TNF-alpha inhibitor using anti-CD20 antibody
AR044388A1 (es) 2003-05-20 2005-09-07 Applied Molecular Evolution Moleculas de union a cd20
CA2526398C (en) 2003-05-21 2014-07-15 Medarex, Inc. Human monoclonal antibodies against bacillus anthracis protective antigen
DE10361599A1 (de) * 2003-12-24 2005-07-28 Boehringer Ingelheim Pharma Gmbh & Co. Kg Flüssigformulierung von Antikörperkonjugaten
BRPI0511196A (pt) 2004-05-19 2007-12-04 Maxygen Inc polipeptìdeo isolado ou recombinante, conjugado, composição, célula hospedeira, vetor, métodos para preparar um polipeptìdeo, para preparar um conjugado, para reduzir o número de cópias de um vìrus em células infectadas com o vìrus, para reduzir o nìvel de rna hcv, dna hbv e rna hiv no soro de um paciente infectado com hcv, hbv e hiv, e, uso do polipeptìdeo, do conjugado ou da composição
ITMI20041245A1 (it) 2004-06-22 2004-09-22 Ibsa Inst Biochimique Sa Composizioni farmaceutiche iniettabnili comprendenti diclofenac sodico e b-ciclodestrina
US20060128654A1 (en) 2004-12-10 2006-06-15 Chunlin Tang Pharmaceutical formulation of cytidine analogs and derivatives
DOP2006000029A (es) 2005-02-07 2006-08-15 Genentech Inc Antibody variants and uses thereof. (variantes de un anticuerpo y usos de las mismas)
US20090208500A1 (en) 2005-06-03 2009-08-20 Genentech, Inc. Method of producing antibodies with improved function
AU2006278573A1 (en) 2005-08-03 2007-02-15 Immunogen, Inc. Immunoconjugate formulations
EP1988878A2 (en) 2006-02-15 2008-11-12 Tika Läkemedel AB Sterilization of corticosteroids with reduced mass loss
TW200831133A (en) 2006-12-11 2008-08-01 Hoffmann La Roche Mab Abeta lyophylized formulation
TW200902725A (en) 2007-04-02 2009-01-16 Genentech Inc Biological markers predictive of rheumatoid arthritis response to B-cell antagonists
ES2750254T3 (es) 2007-09-27 2020-03-25 Amgen Inc Formulaciones farmacéuticas
RU2563823C2 (ru) 2008-11-17 2015-09-20 Дженентек, Инк. Способ и композиция для уменьшения агрегации макромолекул при физиологических условиях
CN101757611A (zh) * 2008-12-23 2010-06-30 天津瑞普生物技术股份有限公司 一种鸡用γ-干扰素干粉吸入剂及其制备方法
US20120294866A1 (en) * 2010-01-19 2012-11-22 F. Hoffmann-La Roche Ag Pharmaceutical formulation for proteins
EP2377830B1 (de) 2010-04-16 2016-04-13 Ivoclar Vivadent AG Lithiumsilikat-Glaskeramik und -Glas mit Übergangsmetalloxid
KR101860963B1 (ko) 2010-04-23 2018-05-24 제넨테크, 인크. 이종다량체 단백질의 생산
US10040855B2 (en) * 2011-05-02 2018-08-07 Millennium Pharmaceuticals, Inc. Formulation for anti-α4β7 antibody
AR095398A1 (es) 2013-03-13 2015-10-14 Genentech Inc Formulaciones con oxidación reducida
AR095399A1 (es) 2013-03-13 2015-10-14 Genentech Inc Formulaciones con oxidación reducida, método
TW201501724A (zh) * 2013-03-15 2015-01-16 Glaxosmithkline Ip No 2 Ltd 低濃度抗體調配物
AU2016380988B2 (en) 2015-12-30 2022-07-21 Genentech, Inc. Formulations with reduced degradation of polysorbate

Patent Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2013164837A1 (en) * 2012-03-07 2013-11-07 Cadila Healthcare Limited Pharmaceutical formulations of tnf-alpha antibodies

Also Published As

Publication number Publication date
HRP20250951T1 (hr) 2025-10-10
US20170189536A1 (en) 2017-07-06
IL259646A (en) 2018-07-31
CN108472379A (zh) 2018-08-31
SG11201804961UA (en) 2018-07-30
AU2016380988A1 (en) 2018-07-05
AU2022256163A1 (en) 2022-11-24
HUE072357T2 (hu) 2025-11-28
CN108472379B (zh) 2022-06-21
PL3397287T3 (pl) 2025-09-22
CN115400220A (zh) 2022-11-29
US10933141B2 (en) 2021-03-02
EP3397287A1 (en) 2018-11-07
US20220040312A1 (en) 2022-02-10
KR102796135B1 (ko) 2025-04-16
JP2022036977A (ja) 2022-03-08
US10525137B2 (en) 2020-01-07
EP3397287B8 (en) 2025-07-23
EP3397287C0 (en) 2025-06-18
IL259646B2 (en) 2023-06-01
KR20250052501A (ko) 2025-04-18
CA3007419A1 (en) 2017-07-06
WO2017117311A1 (en) 2017-07-06
IL299759A (en) 2023-03-01
JP7008023B2 (ja) 2022-01-25
ES3038408T3 (en) 2025-10-13
EP3397287B1 (en) 2025-06-18
KR20180098625A (ko) 2018-09-04
US20200215195A1 (en) 2020-07-09
BR112018010945A2 (pt) 2018-12-04
JP2019504056A (ja) 2019-02-14

Similar Documents

Publication Publication Date Title
US10933141B2 (en) Formulations with reduced degradation of polysorbate
US8318161B2 (en) Anti-oxidized LDL antibody formulation
US20230181533A1 (en) Formulations with reduced oxidation
US20200246465A1 (en) Use of tryptophan derivatives for protein formulations
AU2019202464B2 (en) Formulations with reduced oxidation
US10653779B2 (en) Formulations with reduced oxidation
CA2904169A1 (en) Formulations with reduced oxidation
HK40080539A (en) Formulations to reduce degradation of polysorbate
HK1260077A1 (en) Formulations with reduced degradation of polysorbate
HK1260077B (en) Formulations with reduced degradation of polysorbate

Legal Events

Date Code Title Description
FGA Letters patent sealed or granted (standard patent)