CA3013336A1 - Buffer formulations for enhanced antibody stability - Google Patents

Buffer formulations for enhanced antibody stability Download PDF

Info

Publication number
CA3013336A1
CA3013336A1 CA3013336A CA3013336A CA3013336A1 CA 3013336 A1 CA3013336 A1 CA 3013336A1 CA 3013336 A CA3013336 A CA 3013336A CA 3013336 A CA3013336 A CA 3013336A CA 3013336 A1 CA3013336 A1 CA 3013336A1
Authority
CA
Canada
Prior art keywords
antibody formulation
formulation
buffered
antibody
buffer
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.)
Pending
Application number
CA3013336A
Other languages
English (en)
French (fr)
Inventor
Hiten GUTKA
Maria TADDEI
Jessica CHEUNG
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.)
Outlook Therapeutics Inc
Original Assignee
Oncobiologics 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 Oncobiologics Inc filed Critical Oncobiologics Inc
Publication of CA3013336A1 publication Critical patent/CA3013336A1/en
Pending legal-status Critical Current

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K39/395Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • A61K39/39591Stabilisation, fragmentation
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/12Carboxylic acids; Salts or anhydrides thereof
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/16Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • A61K47/183Amino acids, e.g. glycine, EDTA or aspartame
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/26Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/04Drugs 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P17/00Drugs for dermatological disorders
    • A61P17/06Antipsoriatics
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P19/00Drugs for skeletal disorders
    • A61P19/02Drugs for skeletal disorders for joint disorders, e.g. arthritis, arthrosis
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P19/00Drugs for skeletal disorders
    • A61P19/08Drugs for skeletal disorders for bone diseases, e.g. rachitism, Paget's disease
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P29/00Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00Drugs for immunological or allergic disorders
    • A61P37/02Immunomodulators
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K16/00Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/18Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/24Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against cytokines, lymphokines or interferons
    • C07K16/241Tumor Necrosis Factors
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K2039/54Medicinal preparations containing antigens or antibodies characterised by the route of administration
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/20Immunoglobulins specific features characterized by taxonomic origin
    • C07K2317/21Immunoglobulins specific features characterized by taxonomic origin from primates, e.g. man
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/70Immunoglobulins specific features characterized by effect upon binding to a cell or to an antigen
    • C07K2317/76Antagonist 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)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Organic Chemistry (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Immunology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Epidemiology (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Molecular Biology (AREA)
  • Biochemistry (AREA)
  • Physical Education & Sports Medicine (AREA)
  • Rheumatology (AREA)
  • Genetics & Genomics (AREA)
  • Mycology (AREA)
  • Biophysics (AREA)
  • Microbiology (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Pain & Pain Management (AREA)
  • Dermatology (AREA)
  • Medicinal Preparation (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Peptides Or Proteins (AREA)
CA3013336A 2016-02-03 2017-02-01 Buffer formulations for enhanced antibody stability Pending CA3013336A1 (en)

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 (1)

Publication Number Publication Date
CA3013336A1 true CA3013336A1 (en) 2017-08-10

Family

ID=58046768

Family Applications (1)

Application Number Title Priority Date Filing Date
CA3013336A Pending CA3013336A1 (en) 2016-02-03 2017-02-01 Buffer formulations for enhanced antibody stability

Country Status (8)

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

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
EP2946766B1 (en) * 2014-05-23 2016-03-02 Ares Trading S.A. Liquid pharmaceutical composition
US10696735B2 (en) 2015-01-21 2020-06-30 Outlook Therapeutics, Inc. Modulation of charge variants in a monoclonal antibody composition
MX2018009341A (es) 2016-02-03 2019-05-15 Oncobiologics Inc Formulaciones tamponadas para una mayor estabilidad de anticuerpos.
KR20190024572A (ko) * 2017-08-30 2019-03-08 (주)셀트리온 TNFα 관련 질환을 치료하기 위한 피하 투여 요법
WO2019147824A1 (en) 2018-01-26 2019-08-01 Progenity, Inc. Treatment of a disease of the gastrointestinal tract with a pde4 inhibitor
US20230312700A1 (en) 2018-06-20 2023-10-05 Progenity, Inc. Treatment of a disease of the gastrointestinal tract with a tnf inhibitor
WO2019246312A1 (en) 2018-06-20 2019-12-26 Progenity, Inc. Treatment of a disease of the gastrointestinal tract with an immunomodulator
EP3810268A1 (en) 2018-06-20 2021-04-28 Progenity, Inc. Treatment of a disease of the gastrointestinal tract with an il-12/il-23 inhibitor
WO2019246455A1 (en) 2018-06-20 2019-12-26 Progenity, Inc. Treatment of a disease of the gastrointestinal tract with an integrin inhibitor
US12227565B2 (en) 2018-06-20 2025-02-18 Biora Therapeutics, Inc. Method of formulating a pharmaceutical composition comprising administering an immune modulator to the small intestine
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
AU2020207124A1 (en) * 2019-01-11 2021-07-29 Samsung Bioepis Co., Ltd. Pharmaceutical composition comprising antibody, device comprising same, and use thereof
JP2022548950A (ja) * 2019-09-19 2022-11-22 イノベント バイオロジクス(スーチョウ)カンパニー,リミティド 抗pcsk9抗体を利用したコレステロール関連疾患の予防または治療方法
EP4146175A1 (en) 2020-05-08 2023-03-15 Genmab A/S 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

Family Cites Families (114)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
AU1331892A (en) 1991-02-01 1992-09-07 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
DK0929578T3 (da) 1996-02-09 2003-08-25 Abbott Lab Bermuda Ltd Humane antistoffer, der binder human TNFalfa
KR20010043323A (ko) 1998-05-06 2001-05-25 제넨테크, 인크. 이온 교환 크로마토그래피에 의한 단백질 정제 방법
CA2385745C (en) 2001-06-08 2015-02-17 Abbott Laboratories (Bermuda) Ltd. Methods of administering anti-tnf.alpha. antibodies
NZ555692A (en) 2002-07-19 2009-02-28 Abbott Biotech Ltd Treatment of TNF alpha 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
KR100996801B1 (ko) 2005-03-08 2010-11-25 파마시아 앤드 업존 캄파니 엘엘씨 항-MAdCAM 항체 조성물
JP5757495B2 (ja) 2005-05-16 2015-07-29 アッヴィ バイオテクノロジー リミテッド びらん性多発性関節炎の治療のためのtnf阻害剤の使用
JP5442251B2 (ja) 2005-05-26 2014-03-12 サイトス バイオテクノロジー アーゲー 拡張可能な発酵方法
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
TWI424161B (zh) 2005-11-01 2014-01-21 Abbvie Biotechnology Ltd 利用生物標記診斷關節黏連脊椎炎之方法及組合物
WO2007117490A2 (en) 2006-04-05 2007-10-18 Abbott Biotechnology Ltd. Antibody purification
EP2007426A4 (en) 2006-04-10 2010-06-16 Abbott Biotech Ltd COMPOSITIONS FOR THE TREATMENT OF PSORIASTIC POLYARTHRITIS AND THEIR APPLICATIONS
CA2564435A1 (en) 2006-04-10 2007-10-10 Abbott Biotechnology Ltd. Methods for monitoring and treating intestinal disorders
WO2007120626A2 (en) 2006-04-10 2007-10-25 Abbott Biotechnology Ltd. Uses and compositions for treatment of ankylosing spondylitis
US20080118496A1 (en) 2006-04-10 2008-05-22 Medich John R Uses and compositions for treatment of juvenile rheumatoid arthritis
EP2708242A3 (en) 2006-04-10 2014-03-26 Abbott Biotechnology Ltd Uses and compositions for treatment of ankylosing spondylitis
US9399061B2 (en) 2006-04-10 2016-07-26 Abbvie Biotechnology Ltd Methods for determining efficacy of TNF-α inhibitors for treatment of rheumatoid arthritis
US9605064B2 (en) 2006-04-10 2017-03-28 Abbvie Biotechnology Ltd Methods and compositions for treatment of skin disorders
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
CN103316402A (zh) 2006-06-30 2013-09-25 艾伯维生物技术有限公司 自动注射装置
WO2008032712A1 (fr) 2006-09-11 2008-03-20 Immuno-Biological Laboratories Co., Ltd. Anticorps monoclonal et son utilisation
US8911964B2 (en) 2006-09-13 2014-12-16 Abbvie Inc. Fed-batch method of making human anti-TNF-alpha antibody
EP2500414A1 (en) 2006-09-13 2012-09-19 Abbott Laboratories Cell culture improvements
CA2842964A1 (en) 2006-09-13 2008-03-20 Abbvie Inc. Cell culture improvements
US8034906B2 (en) 2006-10-27 2011-10-11 Abbott Biotechnology Ltd. Crystalline anti-hTNFalpha antibodies
EP2142560A4 (en) 2007-03-30 2010-12-01 Abbott Lab RECOMBINANT EXPRESSION VECTOR ELEMENTS (REVE) FOR INCREASING THE EXPRESSION OF RECOMBINANT PROTEINS IN HOST CELLS
CN105567627B (zh) 2007-04-26 2020-09-29 中外制药株式会社 使用含高浓度氨基酸的培养基的细胞培养方法
WO2008150491A2 (en) 2007-05-31 2008-12-11 Abbott Laboratories BIOMARKERS PREDICTIVE OF THE RESPONSIVENESS TO TNFα INHIBITORS IN AUTOIMMUNE DISORDERS
EP2171451A4 (en) 2007-06-11 2011-12-07 Abbott Biotech Ltd METHOD FOR TREATING JUVENILIAN IDIOPATHIC ARTHRITIS
UA107557C2 (xx) * 2007-07-06 2015-01-26 Композиція антитіла офатумумабу
CA2697163A1 (en) 2007-08-08 2009-02-12 Abbott Laboratories Compositions and methods for crystallizing antibodies
EP2205280B1 (en) 2007-09-27 2019-09-04 Amgen Inc. Pharmaceutical formulations
KR20150080038A (ko) 2007-11-30 2015-07-08 애브비 바이오테크놀로지 리미티드 단백질 제형 및 이의 제조방법
US8883146B2 (en) 2007-11-30 2014-11-11 Abbvie Inc. 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
KR20100120289A (ko) 2008-01-15 2010-11-15 애보트 게엠베하 운트 콤파니 카게 분말상 단백질 조성물 및 이의 제조 방법
EP2240581B1 (en) 2008-01-15 2016-05-11 AbbVie Inc. Improved mammalian expression vectors and uses thereof
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
JP2011517672A (ja) 2008-03-24 2011-06-16 アボツト・バイオテクノロジー・リミテツド 骨損失を治療するための方法及び組成物
PL2282773T3 (pl) 2008-05-02 2014-08-29 Seattle Genetics Inc Sposoby i kompozycje do wytwarzania przeciwciał i pochodnych przeciwciał o obniżonej fukozylacji rdzeniowej
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
AU2009307737B2 (en) 2008-10-20 2015-07-23 Abbvie Inc. Viral inactivation during purification of antibodies
WO2010048190A2 (en) 2008-10-20 2010-04-29 Abbott Laboratories Antibodies that bind to il-12 and methods of purifying the same
CA2738243C (en) 2008-10-29 2020-09-29 Wyeth Llc Formulations of single domain antigen binding molecules
JP2012510468A (ja) 2008-11-28 2012-05-10 アボット・ラボラトリーズ 安定な抗体組成物およびこれを安定させるための方法
US20120053080A1 (en) 2009-03-09 2012-03-01 Juan Cui Protein markers identification for gastric cancer diagnosis
CA2760185A1 (en) 2009-05-04 2010-11-11 Abbott Biotechnology Ltd. Stable high protein concentration formulations of human anti-tnf-alpha antibodies
CN102459603B (zh) 2009-06-02 2013-11-06 瑞泽恩制药公司 岩藻糖基化缺陷型细胞
CA2763164A1 (en) 2009-06-05 2010-12-09 Momenta Pharmaceuticals, Inc. Methods of modulating fucosylation of glycoproteins
US20110059079A1 (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.
BR112012021576A2 (pt) 2010-02-26 2016-10-25 Novo Nordisk As composições estáveis contendo anticorpo.
US9072668B2 (en) 2010-03-09 2015-07-07 Janssen Biotech, Inc. Non-aqueous high concentration reduced viscosity suspension formulations of antibodies
BR112012030530A2 (pt) 2010-05-18 2022-12-20 Abbvie Inc Aparelho e processo para purificação de proteínas
CA2799915C (en) 2010-05-25 2023-09-26 Genentech, Inc. Methods of purifying polypeptides
LT2575884T (lt) 2010-06-03 2018-09-25 Abbvie Biotechnology Ltd Panaudojimai ir kompozicijos, skirti pūlingo hidradenito (hs) gydymui
EP2618904A1 (en) 2010-09-20 2013-07-31 AbbVie Inc. Purification of antibodies using simulated moving bed chromatography
US20120258496A1 (en) 2010-09-27 2012-10-11 Boehringer Ingelheim International Gmbh Production of low fucose antibodies in h4-ii-e rat cells
CA2813747A1 (en) 2010-10-11 2012-04-19 Chen Wang Processes for purification of proteins
US8821865B2 (en) * 2010-11-11 2014-09-02 Abbvie Biotechnology Ltd. High concentration anti-TNFα antibody liquid formulations
NZ611862A (en) 2010-12-28 2015-05-29 Chugai Pharmaceutical Co Ltd Animal cell culturing method
US9062106B2 (en) 2011-04-27 2015-06-23 Abbvie Inc. Methods for controlling the galactosylation profile of recombinantly-expressed proteins
JP6024025B2 (ja) 2011-05-02 2016-11-09 イミューノメディクス、インコーポレイテッドImmunomedics, Inc. 少容量投与用のアロタイプ選択抗体の限外濾過濃縮
JP5897708B2 (ja) 2011-07-01 2016-03-30 アムジエン・インコーポレーテツド 哺乳類細胞培養物
GB201112429D0 (en) 2011-07-19 2011-08-31 Glaxo Group Ltd Antigen-binding proteins with increased FcRn binding
AU2012318590B2 (en) 2011-10-04 2017-05-18 Expression Pathology, Inc. SRM/MRM assay for the ephrin type-A receptor 2 protein
HK1200464A1 (en) 2011-10-24 2015-08-07 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
US9067990B2 (en) 2013-03-14 2015-06-30 Abbvie, Inc. Protein purification using displacement chromatography
US9150645B2 (en) 2012-04-20 2015-10-06 Abbvie, Inc. Cell culture methods to reduce acidic species
US9181572B2 (en) 2012-04-20 2015-11-10 Abbvie, Inc. Methods to modulate lysine variant distribution
US9249182B2 (en) 2012-05-24 2016-02-02 Abbvie, Inc. Purification of antibodies using hydrophobic interaction chromatography
US20150150982A1 (en) 2012-06-12 2015-06-04 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
PE20191815A1 (es) 2012-09-07 2019-12-27 Coherus Biosciences Inc Formulaciones acuosas estables de adalimumab
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 (OSRAM) 2012-10-01 2018-08-04
EP2906683B1 (en) 2012-10-15 2017-05-31 Bristol-Myers Squibb Company Mammalian cell culture processes for protein production
EP2934587A4 (en) 2012-12-18 2016-08-03 Merck Sharp & Dohme Liquid formulations for an anti-TNF-alpha-antibody
JP6533932B2 (ja) 2012-12-28 2019-06-26 アボット カーディオバスキュラー システムズ インコーポレイテッド 抗体を含む治療用組成物
HK1207960A1 (en) 2013-03-12 2016-02-19 Abbvie Inc. Human antibodies that bind human tnf-alpha and methods of preparing the same
WO2014158231A1 (en) 2013-03-14 2014-10-02 Abbvie Inc. Low acidic species compositions and methods for producing and using the same
US9217168B2 (en) 2013-03-14 2015-12-22 Momenta Pharmaceuticals, Inc. Methods of cell culture
WO2014151901A1 (en) 2013-03-14 2014-09-25 Abbvie Inc. Improvement of mammalian cell culture performance through surfactant supplementation of feed media
JP6465794B2 (ja) 2013-04-25 2019-02-06 株式会社カネカ Fab型抗体の分泌量を増大できるFd鎖遺伝子又はL鎖遺伝子
WO2014182658A1 (en) 2013-05-06 2014-11-13 Abbvie Inc. Compositions for cell culture and methods of using the same
AR096713A1 (es) 2013-06-25 2016-01-27 Cadila Healthcare Ltd Proceso de purificación para anticuerpos monoclonales
US20160266141A1 (en) 2013-10-03 2016-09-15 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
US10696735B2 (en) 2015-01-21 2020-06-30 Outlook Therapeutics, 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
CA3010598A1 (en) 2016-01-06 2017-07-13 Oncobiologics, Inc. Modulation of afucosylated species in a monoclonal antibody composition
CA3010600A1 (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
MX2018009341A (es) 2016-02-03 2019-05-15 Oncobiologics Inc Formulaciones tamponadas para una mayor estabilidad de anticuerpos.
MX2018009339A (es) 2016-02-04 2019-01-10 Oncobiologics Inc Métodos para la identificación y análisis de secuencias de aminoácidos de las proteínas.

Also Published As

Publication number Publication date
JP2019504086A (ja) 2019-02-14
WO2017136433A1 (en) 2017-08-10
JP7084308B2 (ja) 2022-06-14
AU2017213775A1 (en) 2018-08-16
US11285210B2 (en) 2022-03-29
US20190030163A1 (en) 2019-01-31
EP3411401A1 (en) 2018-12-12
CN109563161A (zh) 2019-04-02
MX2018009341A (es) 2019-05-15

Similar Documents

Publication Publication Date Title
US11285210B2 (en) Buffer formulations for enhanced antibody stability
US10772960B2 (en) Stable aqueous formulations of adalimumab
AU2014337263B2 (en) Buffer formulations for enhanced antibody stability
CN103998060B (zh) 使用糖与多元醇的结合物稳定的依那西普制剂
CN107635581A (zh) 用于单克隆抗体的稳定液体制剂
AU2016382786A1 (en) Buffered formulations of bevacizumab
HUE029849T2 (en) Liquid pharmaceutical composition
TWI787161B (zh) 含有抗人類tslp受體抗體之醫藥組成物
HUE035707T2 (en) Pharmaceutical composition containing a biological drug
JP2022547162A (ja) 抗IL-23p19抗体製剤
TWI771335B (zh) 穩定藥學調配物
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
HK1204921B (en) Stable liquid formulation of etanercept
HK1204921A1 (en) Stable liquid formulation of etanercept
HK1200720B (en) Etanercept formulations stabilized with combinations of sugars and polyols

Legal Events

Date Code Title Description
EEER Examination request

Effective date: 20220128

EEER Examination request

Effective date: 20220128

EEER Examination request

Effective date: 20220128

EEER Examination request

Effective date: 20220128