BR112014004828A2 - método para preparação de uma composição compreendendo anticorpos altamente concentrados por ultrafiltração - Google Patents

método para preparação de uma composição compreendendo anticorpos altamente concentrados por ultrafiltração

Info

Publication number
BR112014004828A2
BR112014004828A2 BR112014004828A BR112014004828A BR112014004828A2 BR 112014004828 A2 BR112014004828 A2 BR 112014004828A2 BR 112014004828 A BR112014004828 A BR 112014004828A BR 112014004828 A BR112014004828 A BR 112014004828A BR 112014004828 A2 BR112014004828 A2 BR 112014004828A2
Authority
BR
Brazil
Prior art keywords
preparing
composition
highly concentrated
antibodies
ultrafiltration
Prior art date
Application number
BR112014004828A
Other languages
English (en)
Other versions
BR112014004828B1 (pt
BR112014004828B8 (pt
Inventor
Yamada Hidenari
Bender Jean
Lau Kelby
Oh-Eda Masayoshi
Wakayama Rumiko
Tanaka Saeko
Isoda Tomonori
Original Assignee
Chugai Pharmaceutical Co Ltd
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 Chugai Pharmaceutical Co Ltd, Genentech Inc filed Critical Chugai Pharmaceutical Co Ltd
Publication of BR112014004828A2 publication Critical patent/BR112014004828A2/pt
Publication of BR112014004828B1 publication Critical patent/BR112014004828B1/pt
Publication of BR112014004828B8 publication Critical patent/BR112014004828B8/pt

Links

Classifications

    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K1/00—General methods for the preparation of peptides, i.e. processes for the organic chemical preparation of peptides or proteins of any length
    • C07K1/14—Extraction; Separation; Purification
    • C07K1/34—Extraction; Separation; Purification by filtration, ultrafiltration or reverse osmosis
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01D—SEPARATION
    • B01D61/00—Processes of separation using semi-permeable membranes, e.g. dialysis, osmosis or ultrafiltration; Apparatus, accessories or auxiliary operations specially adapted therefor
    • B01D61/14—Ultrafiltration; Microfiltration
    • B01D61/145—Ultrafiltration
    • 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
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01D—SEPARATION
    • B01D2311/00—Details relating to membrane separation process operations and control
    • B01D2311/14—Pressure control
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01D—SEPARATION
    • B01D2311/00—Details relating to membrane separation process operations and control
    • B01D2311/16—Flow or flux control
    • B01D2311/165—Cross-flow velocity control
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01D—SEPARATION
    • B01D2315/00—Details relating to the membrane module operation
    • B01D2315/14—Batch-systems
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01D—SEPARATION
    • B01D2321/00—Details relating to membrane cleaning, regeneration, sterilization or to the prevention of fouling
    • B01D2321/02—Forward flushing
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01D—SEPARATION
    • B01D61/00—Processes of separation using semi-permeable membranes, e.g. dialysis, osmosis or ultrafiltration; Apparatus, accessories or auxiliary operations specially adapted therefor
    • B01D61/14—Ultrafiltration; Microfiltration
    • B01D61/22—Controlling or regulating
    • 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
    • C07K16/28—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/2866—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against receptors for cytokines, lymphokines, interferons

Landscapes

  • Chemical & Material Sciences (AREA)
  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Water Supply & Treatment (AREA)
  • Organic Chemistry (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Immunology (AREA)
  • Biochemistry (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Molecular Biology (AREA)
  • Genetics & Genomics (AREA)
  • Biophysics (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Analytical Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Veterinary Medicine (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Animal Behavior & Ethology (AREA)
  • Epidemiology (AREA)
  • Public Health (AREA)
  • Mycology (AREA)
  • Microbiology (AREA)
  • Peptides Or Proteins (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Separation Using Semi-Permeable Membranes (AREA)
  • Preparation Of Compounds By Using Micro-Organisms (AREA)

Abstract

resumo patente de invenção: "método para preparação de uma composição compreendendo anticorpos altamente concentrados por ultrafiltração". a presente invenção refere-se a um método para preparação de uma composição compreendendo anticorpos altamente concentrados pela ultrafiltração em modo de concentração em batelada tendo uma primeira taxa de alimentação constante e uma segunda taxa de alimentação controlada.
BR112014004828A 2011-09-01 2012-08-31 Métodos para preparação de composições compreendendo anticorpos ou proteínas concentradas por ultrafiltração BR112014004828B8 (pt)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US201161530158P 2011-09-01 2011-09-01
US61/530,158 2011-09-01
PCT/JP2012/005536 WO2013031237A1 (en) 2011-09-01 2012-08-31 Method for preparing a composition comprising highly concentrated antibodies by ultrafiltration

Publications (3)

Publication Number Publication Date
BR112014004828A2 true BR112014004828A2 (pt) 2017-04-04
BR112014004828B1 BR112014004828B1 (pt) 2021-03-09
BR112014004828B8 BR112014004828B8 (pt) 2022-03-29

Family

ID=46982845

Family Applications (1)

Application Number Title Priority Date Filing Date
BR112014004828A BR112014004828B8 (pt) 2011-09-01 2012-08-31 Métodos para preparação de composições compreendendo anticorpos ou proteínas concentradas por ultrafiltração

Country Status (15)

Country Link
US (3) US9630988B2 (pt)
EP (2) EP2750784A1 (pt)
JP (2) JP6363017B2 (pt)
KR (1) KR101993488B1 (pt)
CN (1) CN103889555B (pt)
AU (2) AU2012303372A1 (pt)
BR (1) BR112014004828B8 (pt)
CA (1) CA2847302C (pt)
IL (1) IL231128B (pt)
MX (1) MX359235B (pt)
MY (1) MY182178A (pt)
RU (1) RU2638859C9 (pt)
SG (1) SG11201400260TA (pt)
WO (1) WO2013031237A1 (pt)
ZA (1) ZA201401184B (pt)

Families Citing this family (18)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0983767B1 (en) 1997-03-21 2008-09-10 Chugai Seiyaku Kabushiki Kaisha Preventives or remedies for the treatment of multiple sclerosis containing antagonist anti-IL-6-receptor antibodies
UA80091C2 (en) 2001-04-02 2007-08-27 Chugai Pharmaceutical Co Ltd Remedies for infant chronic arthritis-relating diseases and still's disease which contain an interleukin-6 (il-6) antagonist
GB2401040A (en) 2003-04-28 2004-11-03 Chugai Pharmaceutical Co Ltd Method for treating interleukin-6 related diseases
PE20091174A1 (es) 2007-12-27 2009-08-03 Chugai Pharmaceutical Co Ltd Formulacion liquida con contenido de alta concentracion de anticuerpo
DK2493922T3 (en) 2009-10-26 2017-04-24 Hoffmann La Roche Process for preparing a glycosylated immunoglobulin
TWI603738B (zh) 2010-11-08 2017-11-01 建南德克公司 皮下投予抗－ｉｌ－６受體抗體
DK2739157T3 (en) * 2011-08-03 2018-01-08 Prolacta Bioscience Inc Microfiltration of human milk to reduce bacterial contamination
JP6563910B2 (ja) 2013-07-04 2019-08-21 エフ．ホフマン−ラ ロシュ アーゲーＦ． Ｈｏｆｆｍａｎｎ−Ｌａ Ｒｏｃｈｅ Ａｋｔｉｅｎｇｅｓｅｌｌｓｃｈａｆｔ 血清サンプル中の抗薬物抗体を検出するための干渉抑制イムノアッセイ
WO2016067177A1 (en) 2014-10-27 2016-05-06 Tmci Padovan S.P.A. Improved filtration plant and relative method
CN104673666A (zh) * 2015-03-10 2015-06-03 华东理工大学 一种微型切向流过滤模拟装置
GB201600287D0 (en) * 2016-01-07 2016-02-24 Fujifilm Diosynth Biotechnologies Uk Ltd Process
JP7032381B2 (ja) 2016-09-15 2022-03-08 エヴォクア ウォーター テクノロジーズ エルエルシー 超純水を処理するための方法及びシステム
JP6399723B1 (ja) * 2018-02-21 2018-10-03 株式会社グロータック 自転車用変速操作装置
SG11202100391VA (en) 2018-07-27 2021-02-25 Arc Medical Devices Inc Highly sulfated fucans for the treatment of fibrous adhesions
KR20210044821A (ko) * 2018-08-14 2021-04-23 브리스톨-마이어스 스큅 컴퍼니 개선된 단백질 회수
DE102019101745A1 (de) * 2019-01-24 2020-07-30 Putsch Gmbh & Co. Kg Verfahren zum Betrieb einer Membranfilteranlage
CN112512667B (zh) * 2019-03-05 2022-12-06 Arc医疗器械股份有限公司 用于粘性组合物的切向流过滤的***和方法
CN111018968B (zh) * 2019-12-16 2021-07-27 兴盟生物医药(苏州)有限公司 一种通过超滤浓缩制备高浓度抗体制剂的方法

Family Cites Families (34)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPS6443305A (en) * 1987-08-10 1989-02-15 Fuji Photo Film Co Ltd Cross flow type filtration process
ATE129430T1 (de) * 1989-07-14 1995-11-15 Dow Chemical Co Isotrope oder anisotrope mikroporöse membranen aus syndiotaktischem polystyrol und herstellungsverfahren.
JPH0380921A (ja) * 1989-08-24 1991-04-05 Shinko Pantec Co Ltd 膜濾過装置の運転方法
JPH0778025B2 (ja) 1990-03-20 1995-08-23 日本赤十字社 免疫グロブリンｇの製造方法
ES2134212T3 (es) 1991-04-25 1999-10-01 Chugai Pharmaceutical Co Ltd Anticuerpo humano reconstituido contra el receptor de la interleuquina 6 humano.
JP3091885B2 (ja) 1991-07-05 2000-09-25 株式会社日立製作所 高温型二次電池及び電池モジュール
AU744146B2 (en) 1996-09-26 2002-02-14 Chugai Seiyaku Kabushiki Kaisha Antibody against human parathormone related peptides
UA76934C2 (en) 1996-10-04 2006-10-16 Chugai Pharmaceutical Co Ltd Reconstructed human anti-hm 1.24 antibody, coding dna, vector, host cell, method for production of reconstructed human antibody, pharmaceutical composition and drug for treating myeloma containing reconstructed human anti-hm 1.24 antibody
KR100490507B1 (ko) * 1996-10-10 2005-05-19 네오스 테크놀로지스, 인크. 한외 여과, 역 삼투 및 나노 여과를 사용하는 탄수화물의 정제
CH692479A5 (de) 1997-07-08 2002-07-15 Bucher Guyer Ag Querstrom-Filtrationsanlage sowie Verfahren zum Betrieb einer solchen Anlage.
US6096872A (en) 1997-10-14 2000-08-01 Ortho Diagnostic Systems, Inc. Viral clearance process
BR9909382A (pt) 1998-04-03 2000-12-05 Chugai Pharmaceutical Co Ltd Anticorpo humanizado contra o fator tissular humano (tf) e processo de produção de anticorpo humanizado
DE19827473C1 (de) 1998-06-19 1999-08-26 Sartorius Gmbh Verbesserte Crossflow-Filterkassetten
TWI242043B (en) 2000-03-10 2005-10-21 Chugai Pharmaceutical Co Ltd Polypeptide inducing apoptosis
US6350382B1 (en) 2000-06-23 2002-02-26 Scilog, Inc. Enhancing filtration yields in tangential flow filtration
PT1324776E (pt) 2000-10-12 2009-12-23 Genentech Inc Formulações de proteína concentradas de viscosidade reduzida
EP1327680B1 (en) 2000-10-20 2008-04-02 Chugai Seiyaku Kabushiki Kaisha Modified tpo agonist antibody
WO2002092802A1 (en) * 2001-05-14 2002-11-21 Diversa Corporation Novel methods of enzyme purification
JP2005530845A (ja) 2002-06-21 2005-10-13 アイデック ファーマシューティカルズ コーポレイション 抗体を濃縮するための緩衝化処方物およびその使用方法
EP1601788A4 (en) 2003-02-24 2006-11-15 Gtc Biotherapeutics Inc TANGENTIAL FILTRATION METHODS AND APPARATUS THEREFOR
TW200510532A (en) 2003-07-15 2005-03-16 Chugai Pharmaceutical Co Ltd IgM production by transformed cell and method of quantifying the same
EP1715764B1 (de) * 2004-02-18 2010-12-15 Bucher Unipektin AG Verfahren zur diafiltration eines produktes und vorrichtung zur durchfuhrung des verfahrens
US7410587B2 (en) * 2004-08-03 2008-08-12 Scilog, Inc. Liquid handling for filtration and preparative chromatography
US20060051347A1 (en) * 2004-09-09 2006-03-09 Winter Charles M Process for concentration of antibodies and therapeutic products thereof
DOP2006000029A (es) * 2005-02-07 2006-08-15 Genentech Inc Antibody variants and uses thereof. (variantes de un anticuerpo y usos de las mismas)
US8741600B2 (en) 2007-06-19 2014-06-03 Asahi Kasei Kabushiki Kaisha Method for separation of immunoglobulin monomers
JP5099930B2 (ja) * 2007-06-19 2012-12-19 旭化成株式会社 免疫グロブリン１量体の分離方法
AU2008332271C1 (en) 2007-12-05 2014-04-24 Chugai Seiyaku Kabushiki Kaisha Anti-NR10 antibody and use thereof
PE20091174A1 (es) 2007-12-27 2009-08-03 Chugai Pharmaceutical Co Ltd Formulacion liquida con contenido de alta concentracion de anticuerpo
RU2010151414A (ru) * 2008-05-15 2012-06-20 В.Хэлт Л.П. (Bs) Способ получения фракций молока, обогащенных секреторными иммуноглобулинами
JP2010047527A (ja) 2008-08-22 2010-03-04 Asahi Kasei Corp 免疫グロブリン１量体の分離方法
ES2733346T3 (es) * 2009-03-24 2019-11-28 Wyeth Llc Evaporación por membrana para generar medicamentos proteicos altamente concentrados
JP2010248092A (ja) * 2009-04-13 2010-11-04 Asahi Kasei Corp 免疫グロブリン１量体の分離方法
TWI505838B (zh) 2010-01-20 2015-11-01 Chugai Pharmaceutical Co Ltd Stabilized antibody solution containing

Also Published As

Publication number Publication date
US10590164B2 (en) 2020-03-17
JP2014526371A (ja) 2014-10-06
EP3235557A1 (en) 2017-10-25
ZA201401184B (en) 2014-12-23
JP6363751B2 (ja) 2018-07-25
MX2014002253A (es) 2014-04-30
JP2017131886A (ja) 2017-08-03
BR112014004828B1 (pt) 2021-03-09
CN103889555B (zh) 2018-10-26
NZ621902A (en) 2016-06-24
JP6363017B2 (ja) 2018-07-25
IL231128B (en) 2019-03-31
CN103889555A (zh) 2014-06-25
EP2750784A1 (en) 2014-07-09
AU2017204395A1 (en) 2017-07-20
AU2017204395B2 (en) 2018-11-08
RU2638859C9 (ru) 2018-01-31
US20150037319A1 (en) 2015-02-05
KR20140078642A (ko) 2014-06-25
BR112014004828B8 (pt) 2022-03-29
US20200172569A1 (en) 2020-06-04
KR101993488B1 (ko) 2019-06-26
US20170204135A1 (en) 2017-07-20
SG11201400260TA (en) 2014-03-28
RU2014112230A (ru) 2015-10-10
CA2847302A1 (en) 2013-03-07
MY182178A (en) 2021-01-18
CA2847302C (en) 2021-02-16
MX359235B (es) 2018-09-20
RU2638859C2 (ru) 2017-12-18
WO2013031237A1 (en) 2013-03-07
US9630988B2 (en) 2017-04-25
AU2012303372A1 (en) 2014-02-20
IL231128A0 (en) 2014-03-31

Similar Documents

Publication Publication Date Title
BR112014004828A2 (pt) método para preparação de uma composição compreendendo anticorpos altamente concentrados por ultrafiltração
MX356337B (es) Anticuerpos contra csf-1r humano y sus usos.
BR112014002884A2 (pt) composição para estimulação ovariana controlada
WO2015052106A3 (en) Process for preparing polysiloxane-polycarbonate block cocondensates using a salt of a weak acid
PH12014502010A1 (en) Bispecific antibodies against human tweak and human il17 and uses thereof
CL2016001154A1 (es) Composiciones para prevenir o tratar alergias en infantes a partir de o alimentados por madres no secretoras.
UA114611C2 (uk) Пестицидні композиції і способи, що їх стосуються
MX336682B (es) Anticuerpos contra csf-1r humanos y usos de los mismos.
AR090973A1 (es) Anticuerpos utiles para el diagnostico del cancer
BR112013022927A2 (pt) composição, métodos para substituir ou suplementar ou modificar uma microbiota do cólon de um sujeito, e para tratar um sujeito, e, uso de uma composição
EP3929217A3 (en) Specific sites for modifying antibodies to make immunoconjugates
BR112014020826A2 (pt) moduladores e métodos de uso
MY195289A (en) Anti IL-36R Antibodies
NZ715201A (en) Afucosylated anti-fgfr2iiib antibodies
BR112015012987A2 (pt) composições compreendendo anticorpos anti-cd38 e lenalidomida
PH12016501366A1 (en) Novel anti-baff antibodies
BR112014009866A2 (pt) formulações de anticorpos e métodos
TN2013000378A1 (en) Anti - sclerostin antibody crystals and formulations thereof
BR112013032771A2 (pt) dipeptídio quimicamente e metabolicamente estável possuindo potente atividade bloqueadora de canais de sódio
WO2014145852A3 (en) Imidazo(4,5-b) pyridin-2-yl amides as kv7 channel activators
BR112013019520A2 (pt) método para produção de 2,3-butanodiol por fermentação
GEP201706760B (en) Novel abexinostate salt, associated crystalline form, preparation method thereof and the pharmaceutical compositions containing same
EA201300946A1 (ru) Асимметричные мочевины и их медицинское применение
EA201491286A1 (ru) Способ лечения потери костной массы альвеолярного отростка посредством применения антител к склеростину
BR112017004231A2 (pt) processo para produzir um precipitado estável enriquecido em ficobiliproteínas

Legal Events

Date Code Title Description
B06F Objections, documents and/or translations needed after an examination request according [chapter 6.6 patent gazette]
B06U Preliminary requirement: requests with searches performed by other patent offices: procedure suspended [chapter 6.21 patent gazette]
B07D Technical examination (opinion) related to article 229 of industrial property law [chapter 7.4 patent gazette]

Free format text: DE ACORDO COM O ARTIGO 229-C DA LEI NO 10196/2001, QUE MODIFICOU A LEI NO 9279/96, A CONCESSAO DA PATENTE ESTA CONDICIONADA A ANUENCIA PREVIA DA ANVISA. CONSIDERANDO A APROVACAO DOS TERMOS DO PARECER NO 337/PGF/EA/2010, BEM COMO A PORTARIA INTERMINISTERIAL NO 1065 DE 24/05/2012, ENCAMINHA-SE O PRESENTE PEDIDO PARA AS PROVIDENCIAS CABIVEIS.

B07E Notification of approval relating to section 229 industrial property law [chapter 7.5 patent gazette]
B07A Application suspended after technical examination (opinion) [chapter 7.1 patent gazette]
B09A Decision: intention to grant [chapter 9.1 patent gazette]
B16A Patent or certificate of addition of invention granted [chapter 16.1 patent gazette]

Free format text: PRAZO DE VALIDADE: 20 (VINTE) ANOS CONTADOS A PARTIR DE 31/08/2012, OBSERVADAS AS CONDICOES LEGAIS.

B16C Correction of notification of the grant [chapter 16.3 patent gazette]

Free format text: REF. RPI 2618 DE 09/03/2021 QUANTO AO TITULO.