JP2019504086A5 - - Google Patents

Download PDF

Info

Publication number
JP2019504086A5
JP2019504086A5 JP2018540113A JP2018540113A JP2019504086A5 JP 2019504086 A5 JP2019504086 A5 JP 2019504086A5 JP 2018540113 A JP2018540113 A JP 2018540113A JP 2018540113 A JP2018540113 A JP 2018540113A JP 2019504086 A5 JP2019504086 A5 JP 2019504086A5
Authority
JP
Japan
Prior art keywords
antibody
buffered
formulation
buffer
arginine
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.)
Granted
Application number
JP2018540113A
Other languages
English (en)
Japanese (ja)
Other versions
JP7084308B2 (ja
JP2019504086A (ja
Filing date
Publication date
Application filed filed Critical
Priority claimed from PCT/US2017/016040 external-priority patent/WO2017136433A1/en
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

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 true JP2019504086A5 (cg-RX-API-DMAC7.html) 2020-03-12
JP7084308B2 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 (cg-RX-API-DMAC7.html)
EP (1) EP3411401A1 (cg-RX-API-DMAC7.html)
JP (1) JP7084308B2 (cg-RX-API-DMAC7.html)
CN (1) CN109563161A (cg-RX-API-DMAC7.html)
AU (1) AU2017213775A1 (cg-RX-API-DMAC7.html)
CA (1) CA3013336A1 (cg-RX-API-DMAC7.html)
MX (1) MX2018009341A (cg-RX-API-DMAC7.html)
WO (1) WO2017136433A1 (cg-RX-API-DMAC7.html)

Families Citing this family (18)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US10376582B2 (en) 2013-10-16 2019-08-13 Outlook Therapeutics, Inc. Buffer formulations for enhanced antibody stability
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
US20230041197A1 (en) 2018-06-20 2023-02-09 Progenity, Inc. Treatment of a disease of the gastrointestinal tract with an immunomodulator
WO2019246455A1 (en) 2018-06-20 2019-12-26 Progenity, Inc. Treatment of a disease of the gastrointestinal tract with an integrin inhibitor
WO2019246317A1 (en) 2018-06-20 2019-12-26 Progenity, Inc. Treatment of a disease or condition in a tissue originating from the endoderm
EP3810094A1 (en) 2018-06-20 2021-04-28 Progenity, Inc. Treatment of a disease of the gastrointestinal tract with a jak or other kinase inhibitor
US20210363233A1 (en) 2018-06-20 2021-11-25 Progenity, Inc. Treatment of a disease of the gastrointestinal tract with an il-12/il-23 inhibitor
WO2019246313A1 (en) 2018-06-20 2019-12-26 Progenity, Inc. Treatment of a disease of the gastrointestinal tract with a tnf 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
CN115916166A (zh) 2020-05-08 2023-04-04 健玛保 针对cd3和cd20的双特异性抗体
US20240052026A1 (en) * 2020-12-22 2024-02-15 Bio-Thera Solutions, Ltd. Stable antibody formulation, preparation method therefor, and applications thereof
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
BRPI9707379B8 (pt) 1996-02-09 2015-07-07 Abbvie Biotechnology Ltd Composições farmacêuticas compreendendo anticorpo humano recombinante geneticamente engenheirado, e anticorpo humano recombinante geneticamente engenheirado.
DE69907439T3 (de) 1998-05-06 2014-01-02 Genentech, Inc. Reinigung von proteinen durch ionenaustauschchromatographie
CA2817619A1 (en) 2001-06-08 2002-12-08 Abbott Laboratories (Bermuda) Ltd. Methods of administering anti-tnf.alpha. antibodies
CA2493067A1 (en) 2002-07-19 2004-01-29 Abbott Biotechnology 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
TW201705980A (zh) 2004-04-09 2017-02-16 艾伯維生物技術有限責任公司 用於治療TNFα相關失調症之多重可變劑量療法
AR054233A1 (es) 2005-03-08 2007-06-13 Pharmacia & Upjohn Co Llc Composiciones de anticuerpos igg2
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
EP1885847B1 (en) 2005-05-26 2011-07-06 Cytos Biotechnology AG Scalable fermentation process
PL2390267T3 (pl) 2005-06-07 2013-09-30 Esbatech A Novartis Co Llc Stabilne i rozpuszczalne przeciwciała hamujące TNF(alfa)
US7612181B2 (en) 2005-08-19 2009-11-03 Abbott Laboratories Dual variable domain immunoglobulin and uses thereof
US20070041905A1 (en) 2005-08-19 2007-02-22 Hoffman Rebecca S Method of treating depression using a TNF-alpha antibody
AR058140A1 (es) 2005-10-24 2008-01-23 Wyeth Corp Metodo de produccion proteica utilizando compuestos anti-senescencia
JP5198277B2 (ja) 2005-11-01 2013-05-15 アボツト・バイオテクノロジー・リミテツド バイオマーカーを用いて強直性脊椎炎を診断するための方法及び組成物
EP2738179A1 (en) 2006-04-05 2014-06-04 AbbVie Biotechnology Ltd Antibody purification
EP2666479A3 (en) 2006-04-10 2014-03-26 Abbott Biotechnology Ltd Uses and compositions for treatment of juvenile rheumatoid arthritis
US20080118496A1 (en) 2006-04-10 2008-05-22 Medich John R Uses and compositions for treatment of juvenile rheumatoid arthritis
WO2007120626A2 (en) 2006-04-10 2007-10-25 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
EP2666472A3 (en) 2006-04-10 2014-04-02 Abbott Biotechnology Ltd Uses and compositions for treatment of psoriatic arthritis
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
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
TWI542374B (zh) 2006-06-30 2016-07-21 艾伯維生物技術有限責任公司 自動注射裝置
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
MX345141B (es) 2006-09-13 2017-01-18 Abbvie Inc * Mejoras de cultivos celulares.
EP2500414A1 (en) 2006-09-13 2012-09-19 Abbott Laboratories Cell culture improvements
EP2089428B1 (en) 2006-10-27 2013-11-20 AbbVie Biotechnology Ltd Crystalline anti-htnfalpha antibodies
RU2518340C2 (ru) 2007-03-30 2014-06-10 Эббви Инк Элементы рекомбинантного вектора экспрессии (reves) для усиления экспрессии рекомбинантных белков в клетках-хозяевах
TWI601823B (zh) 2007-04-26 2017-10-11 Chugai Pharmaceutical Co Ltd Cell culture methods using media containing high concentrations of amino acids
EP2165194A4 (en) 2007-05-31 2010-09-08 Abbott Lab BIOMARKERS FOR PREDICTING RESPONSABILITY TO TNF ALPHA INHIBITORS IN AUTOIMMUNE DISEASES
WO2008154543A2 (en) 2007-06-11 2008-12-18 Abbott Biotechnology Ltd. Methods for treating juvenile idiopathic arthritis
UA107557C2 (xx) * 2007-07-06 2015-01-26 Композиція антитіла офатумумабу
MX2010001488A (es) 2007-08-08 2010-03-01 Abbott Lab Composiciones y metodos para cristalizar anticuerpos.
US8383114B2 (en) 2007-09-27 2013-02-26 Amgen Inc. Pharmaceutical formulations
CN101969971A (zh) 2007-11-30 2011-02-09 雅培制药有限公司 蛋白制剂及其制备方法
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
EP2081025B1 (en) 2008-01-15 2010-03-10 Universiteit Utrecht Holding B.V. Method for determining the amino acid sequence of peptides
NZ586576A (en) 2008-01-15 2012-08-31 Abbott Lab Improved mammalian expression vectors and uses thereof
RU2537139C2 (ru) 2008-01-15 2014-12-27 Эбботт Гмбх Унд Ко.Кг Порошковые белковые композиции и способы их получения
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
EP2271671A2 (en) 2008-03-24 2011-01-12 Abbott Biotechnology Ltd. Tnf-alpha inhibitors 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
CN104974251A (zh) 2008-10-20 2015-10-14 Abbvie公司 在抗体纯化过程中的病毒灭活
TWI610936B (zh) 2008-10-20 2018-01-11 艾伯維有限公司 使用蛋白質a親和性層析進行抗體之分離及純化
NZ603619A (en) 2008-10-20 2014-05-30 Abbvie Inc Antibodies that bind to il-12 and methods of purifying the same
US9393304B2 (en) 2008-10-29 2016-07-19 Ablynx N.V. Formulations of single domain antigen binding molecules
WO2010062896A1 (en) 2008-11-28 2010-06-03 Abbott Laboratories Stable antibody compositions and methods for stabilizing same
CN102348979A (zh) 2009-03-09 2012-02-08 乔治亚大学研究基金公司 胃癌诊断用蛋白标记的鉴定
CN104490767A (zh) 2009-05-04 2015-04-08 艾伯维生物技术有限公司 人抗TNF-α抗体的稳定高蛋白质浓度制剂
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
WO2010141855A1 (en) 2009-06-05 2010-12-09 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.
EP3216462A3 (en) 2010-02-26 2017-12-20 Novo Nordisk A/S 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
MX354845B (es) 2010-05-18 2018-03-22 Abbvie Inc Star Aparato y proceso de purificación de proteínas.
EP3299380B1 (en) 2010-05-25 2024-08-28 F. Hoffmann-La Roche AG Methods of purifying polypeptides
PL2575884T3 (pl) 2010-06-03 2018-12-31 Abbvie Biotechnology Ltd Zastosowania i kompozycje do leczenia ropni mnogich pach (HS)
AU2011305754B2 (en) 2010-09-20 2015-11-05 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
SG10201508401TA (en) 2010-10-11 2015-11-27 Abbvie Bahamas Ltd Processes for purification of proteins
US8821865B2 (en) 2010-11-11 2014-09-02 Abbvie Biotechnology Ltd. High concentration anti-TNFα antibody liquid formulations
MX345399B (es) 2010-12-28 2017-01-30 Chugai Pharmaceutical Co Ltd Metodo de cultivo de celulas animales.
EP2702077A2 (en) 2011-04-27 2014-03-05 AbbVie Inc. Methods for controlling the galactosylation profile of recombinantly-expressed proteins
CN103501825B (zh) 2011-05-02 2017-03-15 免疫医疗公司 用于小体积施用的同种异型选择的抗体的超滤浓缩
LT2837680T (lt) 2011-07-01 2020-07-10 Amgen Inc. Žinduolių ląstelių kultūra
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
UY34409A (es) 2011-10-24 2013-05-31 Abbvie Inc Inmunoenlazadores dirigidos contra el tnf
US20140288278A1 (en) 2011-10-31 2014-09-25 Joseph Nti-Gyabaah Chromatography process for resolving heterogeneous antibody aggregates
WO2013114164A1 (en) 2012-01-30 2013-08-08 Dr. Reddy's Laboratories Limited Method for obtaining glycoprotein composition with increased afucosylation content
WO2013114165A1 (en) 2012-01-30 2013-08-08 Dr Reddy's Laboratories Limited Process of obtaining glycoprotein composition with increased afucosylation content
US9334319B2 (en) 2012-04-20 2016-05-10 Abbvie Inc. Low acidic species compositions
US9067990B2 (en) 2013-03-14 2015-06-30 Abbvie, Inc. Protein purification using displacement chromatography
US9181572B2 (en) 2012-04-20 2015-11-10 Abbvie, Inc. Methods to modulate lysine variant distribution
WO2013176754A1 (en) 2012-05-24 2013-11-28 Abbvie Inc. Novel 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
WO2014039903A2 (en) 2012-09-07 2014-03-13 Coherus Biosciences, Inc. Stable aqueous formulations of 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 (cg-RX-API-DMAC7.html) 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
EP2934587A4 (en) 2012-12-18 2016-08-03 Merck Sharp & Dohme Liquid formulations for an anti-TNF-alpha-antibody
US9452138B2 (en) 2012-12-28 2016-09-27 Abbott Cardiovascular Systems Inc. Delivery of biologic therapeutics
EP2830651A4 (en) 2013-03-12 2015-09-02 Abbvie Inc HUMAN ANTIBODIES THAT BIND TNF-ALPHA AND PREPARATION METHODS
US9217168B2 (en) 2013-03-14 2015-12-22 Momenta Pharmaceuticals, Inc. Methods of cell culture
US20140271633A1 (en) 2013-03-14 2014-09-18 Abbvie Inc. Mammalian cell culture performance through surfactant supplementation of feed media
CA2926301A1 (en) 2013-03-14 2014-10-02 Abbvie Inc. Low acidic species compositions and methods for producing and using the same
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
US9416181B2 (en) 2013-05-06 2016-08-16 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
EP3114476A4 (en) 2013-10-03 2017-11-01 Bioanalytix, Inc. Mass spectrometry-based method for identifying and maintaining quality control factors during the development and manufacture of a biologic
US10376582B2 (en) 2013-10-16 2019-08-13 Outlook Therapeutics, Inc. Buffer formulations for enhanced antibody stability
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
ES2600488T3 (es) 2014-05-23 2017-02-09 Ares Trading S.A. Composición farmacéutica líquida
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
TW201636047A (zh) * 2015-01-28 2016-10-16 麥博賽恩斯有限公司 抗-TNF-α抗體之醫藥調配物
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
MX2018008447A (es) 2016-01-06 2019-05-30 Oncobiologics Inc Modulacion de especies afucosilados en una composicion de anticuerpo monoclonal.
CN109153717A (zh) 2016-01-06 2019-01-04 安口生物公司 减少单克隆抗体组合物中的高分子量物类、酸性电荷物类和片段
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.

Similar Documents

Publication Publication Date Title
JP2019504086A5 (cg-RX-API-DMAC7.html)
JP2020518599A5 (cg-RX-API-DMAC7.html)
JP2015510882A5 (cg-RX-API-DMAC7.html)
JP2015527402A5 (cg-RX-API-DMAC7.html)
JP2013543505A5 (cg-RX-API-DMAC7.html)
JP2020138981A5 (cg-RX-API-DMAC7.html)
JP2015231997A5 (cg-RX-API-DMAC7.html)
JP2015508774A5 (cg-RX-API-DMAC7.html)
JP2019536761A5 (cg-RX-API-DMAC7.html)
JP2013531679A5 (cg-RX-API-DMAC7.html)
PE20050586A1 (es) Preparacion farmaceutica que comprende un anticuerpo contra el receptor egfr
HRP20171256T1 (hr) Farmaceutski pripravci karbetocina
JP2018510132A5 (cg-RX-API-DMAC7.html)
JP2016515515A5 (cg-RX-API-DMAC7.html)
JP2013545745A5 (cg-RX-API-DMAC7.html)
HRP20201268T1 (hr) Stabilne formulacije koje sadrže anti-pcsk9 antitijela
JP2012526121A5 (cg-RX-API-DMAC7.html)
RU2011127913A (ru) Составы, содержащие антитела
JP2015526440A5 (cg-RX-API-DMAC7.html)
HRP20191199T1 (hr) Formulacije protutijela anti-prolaktinskog receptora
HRP20241526T1 (hr) Stabilni višedozni pripravci, koji sadrže protutijelo i konzervans
ATE522225T1 (de) Verwendung des peptids phpfhlfvy (renin- inhibitor) in anti-angiogenischer therapie von gewissen erkrankungen
JP2017516848A5 (cg-RX-API-DMAC7.html)
JP2015535237A5 (cg-RX-API-DMAC7.html)
ME02565B (me) Formulacija protutijela protiv il-17