JP7084308B2 - 抗体安定性を増大させるための緩衝液製剤 - Google Patents

抗体安定性を増大させるための緩衝液製剤 Download PDF

Info

Publication number
JP7084308B2
JP7084308B2 JP2018540113A JP2018540113A JP7084308B2 JP 7084308 B2 JP7084308 B2 JP 7084308B2 JP 2018540113 A JP2018540113 A JP 2018540113A JP 2018540113 A JP2018540113 A JP 2018540113A JP 7084308 B2 JP7084308 B2 JP 7084308B2
Authority
JP
Japan
Prior art keywords
antibody
buffer
histidine
acetate
antibody preparation
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
JP2018540113A
Other languages
English (en)
Japanese (ja)
Other versions
JP2019504086A (ja
JP2019504086A5 (enExample
Inventor
グトカ ハイテン
タッデイ マリア
チュン ジェシカ
Original Assignee
アウトルック セラピューティクス，インコーポレイティド
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 アウトルック セラピューティクス，インコーポレイティド filed Critical アウトルック セラピューティクス，インコーポレイティド
Publication of JP2019504086A publication Critical patent/JP2019504086A/ja
Publication of JP2019504086A5 publication Critical patent/JP2019504086A5/ja
Application granted granted Critical
Publication of JP7084308B2 publication Critical patent/JP7084308B2/ja
Active legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Images

Classifications

    • 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
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/12—Carboxylic acids; Salts or anhydrides thereof
    • 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
    • A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • A61K47/183—Amino acids, e.g. glycine, EDTA or aspartame
    • 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
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/04—Drugs for disorders of the alimentary tract or the digestive system for ulcers, gastritis or reflux esophagitis, e.g. antacids, inhibitors of acid secretion, mucosal protectants
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P17/00—Drugs for dermatological disorders
    • A61P17/06—Antipsoriatics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P19/00—Drugs for skeletal disorders
    • A61P19/02—Drugs for skeletal disorders for joint disorders, e.g. arthritis, arthrosis
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P19/00—Drugs for skeletal disorders
    • A61P19/08—Drugs for skeletal disorders for bone diseases, e.g. rachitism, Paget's disease
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00—Drugs for immunological or allergic disorders
    • A61P37/02—Immunomodulators
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/18—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/24—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against cytokines, lymphokines or interferons
    • C07K16/241—Tumor Necrosis Factors
    • 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
    • A61K2039/54—Medicinal preparations containing antigens or antibodies characterised by the route of administration
    • 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
    • C07K2317/70—Immunoglobulins specific features characterized by effect upon binding to a cell or to an antigen
    • C07K2317/76—Antagonist effect on antigen, e.g. neutralization or inhibition of binding

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Engineering & Computer Science (AREA)
  • Organic Chemistry (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Immunology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Epidemiology (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Biochemistry (AREA)
  • Molecular Biology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Rheumatology (AREA)
  • Physical Education & Sports Medicine (AREA)
  • Biophysics (AREA)
  • Genetics & Genomics (AREA)
  • Microbiology (AREA)
  • Mycology (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Pain & Pain Management (AREA)
  • Dermatology (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Medicinal Preparation (AREA)
  • Peptides Or Proteins (AREA)
JP2018540113A 2016-02-03 2017-02-01 抗体安定性を増大させるための緩衝液製剤 Active JP7084308B2 (ja)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US201662290654P 2016-02-03 2016-02-03
US62/290,654 2016-02-03
PCT/US2017/016040 WO2017136433A1 (en) 2016-02-03 2017-02-01 Buffer formulations for enhanced antibody stability

Publications (3)

Publication Number Publication Date
JP2019504086A JP2019504086A (ja) 2019-02-14
JP2019504086A5 JP2019504086A5 (enExample) 2020-03-12
JP7084308B2 true JP7084308B2 (ja) 2022-06-14

Family

ID=58046768

Family Applications (1)

Application Number Title Priority Date Filing Date
JP2018540113A Active JP7084308B2 (ja) 2016-02-03 2017-02-01 抗体安定性を増大させるための緩衝液製剤

Country Status (8)

Country Link
US (1) US11285210B2 (enExample)
EP (1) EP3411401A1 (enExample)
JP (1) JP7084308B2 (enExample)
CN (1) CN109563161A (enExample)
AU (1) AU2017213775A1 (enExample)
CA (1) CA3013336A1 (enExample)
MX (1) MX2018009341A (enExample)
WO (1) WO2017136433A1 (enExample)

Families Citing this family (18)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN106170298B (zh) 2013-10-16 2024-01-09 前瞻疗法公司 用于提高抗体稳定性的缓冲液制剂
ES2572919T3 (es) * 2014-05-23 2016-06-03 Ares Trading S.A. Composición farmacéutica líquida
WO2016118707A1 (en) 2015-01-21 2016-07-28 Oncobiologics, Inc. Modulation of charge variants in a monoclonal antibody composition
CN109563161A (zh) 2016-02-03 2019-04-02 安口生物公司 用于提高抗体稳定性的缓冲制剂
KR20190024572A (ko) * 2017-08-30 2019-03-08 (주)셀트리온 TNFα 관련 질환을 치료하기 위한 피하 투여 요법
US20210031012A1 (en) 2018-01-26 2021-02-04 Progenity, Inc. Treatment of a disease of the gastrointestinal tract with a pde4 inhibitor
WO2019246312A1 (en) 2018-06-20 2019-12-26 Progenity, Inc. Treatment of a disease of the gastrointestinal tract with an immunomodulator
WO2019246271A1 (en) 2018-06-20 2019-12-26 Progenity, Inc. Treatment of a disease of the gastrointestinal tract with an il-12/il-23 inhibitor
WO2019246317A1 (en) 2018-06-20 2019-12-26 Progenity, Inc. Treatment of a disease or condition in a tissue originating from the endoderm
US20230312700A1 (en) 2018-06-20 2023-10-05 Progenity, Inc. Treatment of a disease of the gastrointestinal tract with a tnf inhibitor
WO2019246455A1 (en) 2018-06-20 2019-12-26 Progenity, Inc. Treatment of a disease of the gastrointestinal tract with an integrin inhibitor
US12171764B2 (en) 2018-06-20 2024-12-24 Biora Therapeutics, Inc. Treatment of a disease of the gastrointestinal tract with a JAK or other kinase inhibitor
KR20210102954A (ko) * 2019-01-11 2021-08-20 삼성바이오에피스 주식회사 항체를 포함하는 약학적 조성물, 이를 포함하는 디바이스, 및 이의 용도
KR20220064998A (ko) * 2019-09-19 2022-05-19 이노벤트 바이오로직스 (쑤저우) 컴퍼니, 리미티드 콜레스테롤 관련 질환을 예방하거나 치료하기 위한 방법에 있어서 항 pcsk9 항체의 용도
IL297986A (en) 2020-05-08 2023-01-01 Genmab As Bispecific antibodies against cd3 and cd20
WO2022135395A1 (zh) * 2020-12-22 2022-06-30 百奥泰生物制药股份有限公司 稳定的抗体制剂及其制备方法和应用
GB202115121D0 (en) * 2021-10-21 2021-12-08 Ucb Biopharma Sprl Formulations
GB202115127D0 (en) * 2021-10-21 2021-12-08 Ucb Biopharma Sprl Formulations

Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2015527402A (ja) 2012-09-07 2015-09-17 コヒラス・バイオサイエンシズ・インコーポレイテッド 安定水性アダリムマブ製剤

Family Cites Families (113)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1992013876A1 (en) 1991-02-01 1992-08-20 Coulter Corporation METHOD OF PRODUCING F(ab')2 FRAGMENTS OF IMMUNOGLOBULINS
US6090382A (en) 1996-02-09 2000-07-18 Basf Aktiengesellschaft Human antibodies that bind human TNFα
CN103275221B (zh) 1996-02-09 2016-08-17 艾伯维生物技术有限公司 结合人TNFα的人抗体
DK1308456T3 (da) 1998-05-06 2007-12-27 Genentech Inc Antistofoprensning ved ionbytterkromatografi
CA2817619A1 (en) 2001-06-08 2002-12-08 Abbott Laboratories (Bermuda) Ltd. Methods of administering anti-tnf.alpha. antibodies
MY151032A (en) 2002-07-19 2014-03-31 Abbott Lab S A Treatment of tnf? related disorders
US20040033228A1 (en) 2002-08-16 2004-02-19 Hans-Juergen Krause Formulation of human antibodies for treating TNF-alpha associated disorders
MY150740A (en) 2002-10-24 2014-02-28 Abbvie Biotechnology Ltd Low dose methods for treating disorders in which tnf? activity is detrimental
US8227241B2 (en) 2004-03-12 2012-07-24 Unigene Laboratories, Inc. Bacterial host cell for the direct expression of peptides
TWI439284B (zh) 2004-04-09 2014-06-01 Abbvie Biotechnology Ltd 用於治療ＴＮＦα相關失調症之多重可變劑量療法
HUE028410T2 (en) 2005-03-08 2016-12-28 Pfizer Prod Inc Anti-ctla-4 antibody compositions
CA2608728A1 (en) 2005-05-16 2006-11-23 Abbott Biotechnology Ltd. Use of tnfa inhibitor for treatment of erosive polyarthritis
CA2608579C (en) 2005-05-26 2019-09-10 Cytos Biotechnology Ag Scalable fermentation process
EP2390267B1 (en) 2005-06-07 2013-06-05 ESBATech - a Novartis Company LLC Stable and soluble antibodies inhibiting TNF(alpha)
US20070041905A1 (en) 2005-08-19 2007-02-22 Hoffman Rebecca S Method of treating depression using a TNF-alpha antibody
US7612181B2 (en) 2005-08-19 2009-11-03 Abbott Laboratories Dual variable domain immunoglobulin and uses thereof
AR058140A1 (es) 2005-10-24 2008-01-23 Wyeth Corp Metodo de produccion proteica utilizando compuestos anti-senescencia
NZ567286A (en) 2005-11-01 2012-03-30 Abbott Biotechnolgy Ltd Methods and compositions for diagnosing ankylosing spondylitis using biomarkers
KR20150064254A (ko) 2006-04-05 2015-06-10 애브비 바이오테크놀로지 리미티드 항체 정제
EP2010214A4 (en) 2006-04-10 2010-06-16 Abbott Biotech Ltd USES AND COMPOSITIONS FOR THE TREATMENT OF RHEUMATOID ARTHRITIS
EP2703010A3 (en) 2006-04-10 2014-08-06 AbbVie Biotechnology Ltd Uses and compositions for treatment of rheumatoid arthritis
WO2007120626A2 (en) 2006-04-10 2007-10-25 Abbott Biotechnology Ltd. Uses and compositions for treatment of ankylosing spondylitis
CA2564435A1 (en) 2006-04-10 2007-10-10 Abbott Biotechnology Ltd. Methods for monitoring and treating intestinal disorders
US9605064B2 (en) 2006-04-10 2017-03-28 Abbvie Biotechnology Ltd Methods and compositions for treatment of skin disorders
US20080118496A1 (en) 2006-04-10 2008-05-22 Medich John R Uses and compositions for treatment of juvenile rheumatoid arthritis
US9624295B2 (en) 2006-04-10 2017-04-18 Abbvie Biotechnology Ltd. Uses and compositions for treatment of psoriatic arthritis
US7846724B2 (en) 2006-04-11 2010-12-07 Hoffmann-La Roche Inc. Method for selecting CHO cell for production of glycosylated antibodies
US20080311043A1 (en) 2006-06-08 2008-12-18 Hoffman Rebecca S Uses and compositions for treatment of psoriatic arthritis
US20100021451A1 (en) 2006-06-08 2010-01-28 Wong Robert L Uses and compositions for treatment of ankylosing spondylitis
SG173339A1 (en) 2006-06-30 2011-08-29 Abbott Biotech Ltd Automatic injection device
JP5437633B2 (ja) 2006-09-11 2014-03-12 株式会社 免疫生物研究所 モノクローナル抗体およびその用途
US8911964B2 (en) 2006-09-13 2014-12-16 Abbvie Inc. Fed-batch method of making human anti-TNF-alpha antibody
EP2500415A1 (en) 2006-09-13 2012-09-19 Abbott Laboratories Cell culture improvements
MX345141B (es) 2006-09-13 2017-01-18 Abbvie Inc * Mejoras de cultivos celulares.
NZ576133A (en) 2006-10-27 2012-10-26 Abbott Biotech Ltd Crystalline anti-htnfalpha antibodies
BRPI0809361A2 (pt) 2007-03-30 2014-09-02 Abbott Lab Elementos de vetor de expressão recombinante (reves) para melhorar a expressão de proteínas recombinantes em células hospedeiras
ES2624185T3 (es) 2007-04-26 2017-07-13 Chugai Seiyaku Kabushiki Kaisha Método de cultivo celular que utiliza un medio enriquecido con aminoácidos
WO2008150491A2 (en) 2007-05-31 2008-12-11 Abbott Laboratories BIOMARKERS PREDICTIVE OF THE RESPONSIVENESS TO TNFα INHIBITORS IN AUTOIMMUNE DISORDERS
US8999337B2 (en) 2007-06-11 2015-04-07 Abbvie Biotechnology Ltd. Methods for treating juvenile idiopathic arthritis by inhibition of TNFα
UA107557C2 (xx) * 2007-07-06 2015-01-26 Композиція антитіла офатумумабу
US8753839B2 (en) 2007-08-08 2014-06-17 Abbvie Inc. Compositions and methods for crystallizing antibodies
CA2701032C (en) 2007-09-27 2021-01-26 Amgen Inc. Pharmaceutical formulations
US8883146B2 (en) 2007-11-30 2014-11-11 Abbvie Inc. Protein formulations and methods of making same
SG186607A1 (en) 2007-11-30 2013-01-30 Abbott Lab Protein formulations and methods of making same
WO2009073805A2 (en) * 2007-12-04 2009-06-11 Verdezyne, Inc. Aglycosylated therapeutic antibodies and therapeutic antibody-encoding nucleotide sequences
ES2579231T3 (es) 2008-01-15 2016-08-08 Abbvie Inc Vectores de expresión de mamíferos mejorados y usos de los mismos
JP6078217B2 (ja) 2008-01-15 2017-02-08 アッヴィ・ドイチュラント・ゲー・エム・ベー・ハー・ウント・コー・カー・ゲー 粉末化されたタンパク質組成物及びその作製方法
EP2081025B1 (en) 2008-01-15 2010-03-10 Universiteit Utrecht Holding B.V. Method for determining the amino acid sequence of peptides
TWI472339B (zh) 2008-01-30 2015-02-11 Genentech Inc 包含結合至ｈｅｒ２結構域ii之抗體及其酸性變異體的組合物
WO2009118662A2 (en) 2008-03-24 2009-10-01 Abbott Biotechnology Ltd. Methods and compositions for treating bone loss
EP2282773B2 (en) 2008-05-02 2025-03-05 Seagen Inc. Methods and compositions for making antibodies and antibody derivatives with reduced core fucosylation
TW201024319A (en) 2008-10-20 2010-07-01 Abbott Lab Antibodies that bind to IL-12 and methods of purifying the same
NZ592095A (en) 2008-10-20 2013-01-25 Abbott Lab Isolation and purification of il-12 and tnf-alpha antibodies using protein a affinity chromatography
EP2346897A2 (en) 2008-10-20 2011-07-27 Abbott Laboratories Viral inactivation during purification of antibodies
BRPI0919979A2 (pt) 2008-10-29 2015-12-15 Wyeth Llc formulações de moléculas de ligação de antígeno de domínio único
WO2010062896A1 (en) 2008-11-28 2010-06-03 Abbott Laboratories Stable antibody compositions and methods for stabilizing same
US20120053080A1 (en) 2009-03-09 2012-03-01 Juan Cui Protein markers identification for gastric cancer diagnosis
SG175188A1 (en) * 2009-05-04 2011-11-28 Abbott Biotech Ltd Stable high protein concentration formulations of human anti-tnf-alpha-antibodies
JP5744856B2 (ja) 2009-06-02 2015-07-08 リジェネロン・ファーマシューティカルズ・インコーポレイテッドＲｅｇｅｎｅｒｏｎ Ｐｈａｒｍａｃｅｕｔｉｃａｌｓ， Ｉｎｃ． フコシル化欠損細胞
AU2010256455A1 (en) 2009-06-05 2012-01-19 Momenta Pharmaceuticals, Inc. Methods of modulating fucosylation of glycoproteins
WO2011028962A1 (en) 2009-09-04 2011-03-10 Xoma Technology Ltd. Antibody coformulations
AR078161A1 (es) 2009-09-11 2011-10-19 Hoffmann La Roche Formulaciones farmaceuticas muy concentradas de un anticuerpo anti cd20. uso de la formulacion. metodo de tratamiento.
CA2789061A1 (en) 2010-02-26 2011-09-01 Henrik Parshad Stable antibody containing compositions
US9072668B2 (en) 2010-03-09 2015-07-07 Janssen Biotech, Inc. Non-aqueous high concentration reduced viscosity suspension formulations of antibodies
JP6039550B2 (ja) 2010-05-18 2016-12-07 アッヴィ・インコーポレイテッド タンパク質の精製装置および方法
PL3299380T3 (pl) 2010-05-25 2024-12-16 F. Hoffmann-La Roche Ag Sposoby oczyszczania polipeptydów
PL2575884T3 (pl) 2010-06-03 2018-12-31 Abbvie Biotechnology Ltd Zastosowania i kompozycje do leczenia ropni mnogich pach (HS)
KR20130114143A (ko) 2010-09-20 2013-10-16 애브비 인코포레이티드 모사 이동층 크로마토그래피를 이용한 항체의 정제
US20120258496A1 (en) 2010-09-27 2012-10-11 Boehringer Ingelheim International Gmbh Production of low fucose antibodies in h4-ii-e rat cells
WO2012051147A1 (en) 2010-10-11 2012-04-19 Abbott Laboratories Processes for purification of proteins
US8821865B2 (en) 2010-11-11 2014-09-02 Abbvie Biotechnology Ltd. High concentration anti-TNFα antibody liquid formulations
EP2660328A4 (en) 2010-12-28 2016-07-13 Chugai Pharmaceutical Co Ltd ANIMAL CELL CULTURE METHOD
US9062106B2 (en) 2011-04-27 2015-06-23 Abbvie Inc. Methods for controlling the galactosylation profile of recombinantly-expressed proteins
AU2012250924B2 (en) 2011-05-02 2017-05-25 Immunomedics, Inc. Ultrafiltration concentration of allotype selected antibodies for small-volume administration
DK2726600T3 (en) 2011-07-01 2017-05-15 Amgen Inc Mammalian Cell Culture
GB201112429D0 (en) 2011-07-19 2011-08-31 Glaxo Group Ltd Antigen-binding proteins with increased FcRn binding
EP2764082B1 (en) 2011-10-04 2018-05-23 Expression Pathology, Inc. Srm/mrm assay for the ephrin type-a receptor 2 protein
AU2012328921B2 (en) 2011-10-24 2017-05-11 Abbvie Inc. Immunobinders directed against TNF
US20140288278A1 (en) 2011-10-31 2014-09-25 Joseph Nti-Gyabaah Chromatography process for resolving heterogeneous antibody aggregates
WO2013114165A1 (en) 2012-01-30 2013-08-08 Dr Reddy's Laboratories Limited Process of obtaining glycoprotein composition with increased afucosylation content
WO2013114164A1 (en) 2012-01-30 2013-08-08 Dr. Reddy's Laboratories Limited Method for obtaining glycoprotein composition with increased afucosylation content
US9334319B2 (en) 2012-04-20 2016-05-10 Abbvie Inc. Low acidic species compositions
WO2013158273A1 (en) 2012-04-20 2013-10-24 Abbvie Inc. Methods to modulate c-terminal lysine variant distribution
US9067990B2 (en) 2013-03-14 2015-06-30 Abbvie, Inc. Protein purification using displacement chromatography
US9249182B2 (en) 2012-05-24 2016-02-02 Abbvie, Inc. Purification of antibodies using hydrophobic interaction chromatography
EP2863951A1 (en) 2012-06-12 2015-04-29 Boehringer Ingelheim International GmbH Pharmaceutical formulation for a therapeutic antibody
US9512214B2 (en) 2012-09-02 2016-12-06 Abbvie, Inc. Methods to control protein heterogeneity
JP5874587B2 (ja) 2012-09-10 2016-03-02 株式会社島津製作所 アミノ酸配列解析方法及び装置
NO2760138T3 (enExample) 2012-10-01 2018-08-04
CN104822826B (zh) 2012-10-15 2019-04-30 百时美施贵宝公司 用于蛋白产生的哺乳动物细胞培养过程
WO2014099636A1 (en) 2012-12-18 2014-06-26 Merck Sharp & Dohme Corp. Liquid formulations for an anti-tnf alpha antibody
US9452138B2 (en) 2012-12-28 2016-09-27 Abbott Cardiovascular Systems Inc. Delivery of biologic therapeutics
AU2013381687A1 (en) 2013-03-12 2015-09-24 Abbvie Inc. Human antibodies that bind human TNF-alpha and methods of preparing the same
US20140271633A1 (en) 2013-03-14 2014-09-18 Abbvie Inc. Mammalian cell culture performance through surfactant supplementation of feed media
US9217168B2 (en) 2013-03-14 2015-12-22 Momenta Pharmaceuticals, Inc. Methods of cell culture
AU2013384204B2 (en) 2013-03-14 2017-03-16 Abbvie Inc. Low acidic species compositions and methods for producing and using the same
EP2990485B1 (en) 2013-04-25 2019-09-11 Kaneka Corporation Fd chain gene or l chain gene each capable of increasing secretion amount of fab-type antibody
WO2014182658A1 (en) 2013-05-06 2014-11-13 Abbvie Inc. Compositions for cell culture and methods of using the same
TWI596107B (zh) 2013-06-25 2017-08-21 卡地拉保健有限公司 單株抗體之新穎純化方法
WO2015051310A2 (en) 2013-10-03 2015-04-09 Bioanalytix, Inc. Mass spectrometry-based method for identifying and maintaining quality control factors during the development and manufacture of a biologic
CN106170298B (zh) 2013-10-16 2024-01-09 前瞻疗法公司 用于提高抗体稳定性的缓冲液制剂
US9085618B2 (en) 2013-10-18 2015-07-21 Abbvie, Inc. Low acidic species compositions and methods for producing and using the same
WO2015140700A1 (en) 2014-03-19 2015-09-24 Dr. Reddy's Laboratories Limited Cell culture process
EP3050557A1 (en) * 2014-05-23 2016-08-03 Ares Trading S.A. Liquid pharmaceutical composition
HUP1400510A1 (hu) 2014-10-28 2016-05-30 Richter Gedeon Nyrt Gyógyászati TNFalfa ellenes antitest készítmény
CN105044222B (zh) 2014-12-19 2017-09-12 浙江辉肽生命健康科技有限公司 生物活性多肽的分析测试和鉴定方法
WO2016118707A1 (en) 2015-01-21 2016-07-28 Oncobiologics, Inc. Modulation of charge variants in a monoclonal antibody composition
AR103544A1 (es) 2015-01-28 2017-05-17 Mabxience S A FORMULACIONES FARMACÉUTICAS PARA ANTICUERPOS ANTI-TNF-a
CN105779394B (zh) 2015-03-20 2020-03-24 广东东阳光药业有限公司 一种降低抗体酸性峰含量和改良抗体糖型的细胞培养方法
WO2017120359A1 (en) 2016-01-06 2017-07-13 Oncobiologics, Inc. Reduction of high molecular weight species, acidic charge species, and fragments in a monoclonal antibody composition
WO2017120347A1 (en) 2016-01-06 2017-07-13 Oncobiologics, Inc. Modulation of afucosylated species in a monoclonal antibody composition
CN109563161A (zh) 2016-02-03 2019-04-02 安口生物公司 用于提高抗体稳定性的缓冲制剂
AU2017214586A1 (en) 2016-02-04 2018-08-16 Outlook Therapeutics, Inc. Methods for identifying and analyzing amino acid sequences of proteins

Patent Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2015527402A (ja) 2012-09-07 2015-09-17 コヒラス・バイオサイエンシズ・インコーポレイテッド 安定水性アダリムマブ製剤

Also Published As

Publication number Publication date
JP2019504086A (ja) 2019-02-14
WO2017136433A1 (en) 2017-08-10
EP3411401A1 (en) 2018-12-12
CA3013336A1 (en) 2017-08-10
MX2018009341A (es) 2019-05-15
US11285210B2 (en) 2022-03-29
AU2017213775A1 (en) 2018-08-16
CN109563161A (zh) 2019-04-02
US20190030163A1 (en) 2019-01-31

Similar Documents

Publication Publication Date Title
JP7084308B2 (ja) 抗体安定性を増大させるための緩衝液製剤
US10772960B2 (en) Stable aqueous formulations of adalimumab
JP6526025B2 (ja) 抗体安定性を増強する緩衝液製剤
JP7208302B2 (ja) 抗ヒトｔｓｌｐ受容体抗体含有医薬組成物
HK40037264A (en) Stable aqueous formulations of adalimumab
HK1210601B (en) Stable aqueous formulations of adalimumab
HK1230934B (zh) 用於提高抗体稳定性的缓冲液制剂
HK1230934A1 (en) Buffer formulations for enhanced antibody stability

Legal Events

Date Code Title Description
A521 Request for written amendment filed

Free format text: JAPANESE INTERMEDIATE CODE: A523

Effective date: 20200129

A621 Written request for application examination

Free format text: JAPANESE INTERMEDIATE CODE: A621

Effective date: 20200129

A131 Notification of reasons for refusal

Free format text: JAPANESE INTERMEDIATE CODE: A131

Effective date: 20210119

A601 Written request for extension of time

Free format text: JAPANESE INTERMEDIATE CODE: A601

Effective date: 20210413

A521 Request for written amendment filed

Free format text: JAPANESE INTERMEDIATE CODE: A523

Effective date: 20210719

A131 Notification of reasons for refusal

Free format text: JAPANESE INTERMEDIATE CODE: A131

Effective date: 20211130

A521 Request for written amendment filed

Free format text: JAPANESE INTERMEDIATE CODE: A523

Effective date: 20220224

TRDD Decision of grant or rejection written
A01 Written decision to grant a patent or to grant a registration (utility model)

Free format text: JAPANESE INTERMEDIATE CODE: A01

Effective date: 20220510

A61 First payment of annual fees (during grant procedure)

Free format text: JAPANESE INTERMEDIATE CODE: A61

Effective date: 20220602

R150 Certificate of patent or registration of utility model

Ref document number: 7084308

Country of ref document: JP

Free format text: JAPANESE INTERMEDIATE CODE: R150

S531 Written request for registration of change of domicile

Free format text: JAPANESE INTERMEDIATE CODE: R313531

R350 Written notification of registration of transfer

Free format text: JAPANESE INTERMEDIATE CODE: R350

R250 Receipt of annual fees

Free format text: JAPANESE INTERMEDIATE CODE: R250