BR112016003196A8 - método para separar anticorpos biespecíficos - Google Patents

método para separar anticorpos biespecíficos Download PDF

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Publication number
BR112016003196A8
BR112016003196A8 BR112016003196A BR112016003196A BR112016003196A8 BR 112016003196 A8 BR112016003196 A8 BR 112016003196A8 BR 112016003196 A BR112016003196 A BR 112016003196A BR 112016003196 A BR112016003196 A BR 112016003196A BR 112016003196 A8 BR112016003196 A8 BR 112016003196A8
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BR
Brazil
Prior art keywords
antibody
bispecific antibody
bispecific antibodies
bispecific
products
Prior art date
Application number
BR112016003196A
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English (en)
Other versions
BR112016003196A2 (pt
Inventor
Sabine Bertl
Harald Duerr
Andreas Schaubmar
Original Assignee
Hoffmann La Roche
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 Hoffmann La Roche filed Critical Hoffmann La Roche
Publication of BR112016003196A2 publication Critical patent/BR112016003196A2/pt
Publication of BR112016003196A8 publication Critical patent/BR112016003196A8/pt

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    • 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
    • C07K1/16—Extraction; Separation; Purification by chromatography
    • C07K1/18—Ion-exchange chromatography
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01D—SEPARATION
    • B01D15/00—Separating processes involving the treatment of liquids with solid sorbents; Apparatus therefor
    • B01D15/08—Selective adsorption, e.g. chromatography
    • B01D15/26—Selective adsorption, e.g. chromatography characterised by the separation mechanism
    • B01D15/36—Selective adsorption, e.g. chromatography characterised by the separation mechanism involving ionic interaction
    • B01D15/361—Ion-exchange
    • B01D15/362—Cation-exchange
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01D—SEPARATION
    • B01D15/00—Separating processes involving the treatment of liquids with solid sorbents; Apparatus therefor
    • B01D15/08—Selective adsorption, e.g. chromatography
    • B01D15/26—Selective adsorption, e.g. chromatography characterised by the separation mechanism
    • B01D15/38—Selective adsorption, e.g. chromatography characterised by the separation mechanism involving specific interaction not covered by one or more of groups B01D15/265 - B01D15/36
    • B01D15/3804—Affinity chromatography
    • B01D15/3809—Affinity chromatography of the antigen-antibody type, e.g. protein A, G, L chromatography
    • 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
    • C07K1/16—Extraction; Separation; Purification by chromatography
    • C07K1/22—Affinity chromatography or related techniques based upon selective absorption processes
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • 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
    • C07K16/22—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against growth factors ; against growth regulators
    • 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
    • C07K16/244—Interleukins [IL]
    • 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
    • C07K16/2863—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 growth factors, growth regulators
    • 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
    • C07K16/2875—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against the NGF/TNF superfamily, e.g. CD70, CD95L, CD153, CD154
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/46—Hybrid immunoglobulins
    • C07K16/468—Immunoglobulins having two or more different antigen binding sites, e.g. multifunctional antibodies
    • 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
    • C07K2317/51—Complete heavy chain or Fd fragment, i.e. VH + CH1
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/50—Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/52—Constant or Fc region; Isotype
    • 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'
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/60—Immunoglobulins specific features characterized by non-natural combinations of immunoglobulin fragments
    • C07K2317/66—Immunoglobulins specific features characterized by non-natural combinations of immunoglobulin fragments comprising a swap of domains, e.g. CH3-CH2, VH-CL or VL-CH1

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  • Chemical & Material Sciences (AREA)
  • Health & Medical Sciences (AREA)
  • Organic Chemistry (AREA)
  • Immunology (AREA)
  • Molecular Biology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Biophysics (AREA)
  • General Health & Medical Sciences (AREA)
  • Genetics & Genomics (AREA)
  • Medicinal Chemistry (AREA)
  • Biochemistry (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Analytical Chemistry (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Peptides Or Proteins (AREA)

Abstract

resumo “método de separação de anticorpos” a presente invenção refere-se a métodos que compreendem o uso de cromatografia de hidroxiapatita para separar um anticorpo biespecífico de uma solução que também compreende um ou mais subprodutos específicos da produção de anticorpos biespecíficos. subprodutos específicos da produção de anticorpos biespecíficos (subprodutos específicos de anticorpos biespecíficos, “basb”) incluem fragmentos do anticorpo biespecífico e variantes do anticorpo com peso molecular maior, em que o fragmento e/ou variante compreende um domínio fc, mas não exibem afinidade para os dois epítopos e/ou antígenos diferentes, conforme exibido pelo anticorpo biespecífico desejado. os métodos de acordo com a presente invenção compreendem, portanto, a separação de um anticorpo biespecífico de um ou mais dos seus basbs. os métodos de cromatografia de hidroxiapatita de acordo com a presente invenção podem ser utilizados isoladamente ou adicionalmente combinados com processos de purificação e operações unitárias padrão conforme conhecido na técnica para atingir qualquer nível de pureza de anticorpo biespecífico necessário, por exemplo, para aplicações terapêuticas e/ou em diagnóstico.
BR112016003196A 2013-08-19 2014-08-18 método para separar anticorpos biespecíficos BR112016003196A8 (pt)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
EP13180912 2013-08-19
PCT/EP2014/067552 WO2015024896A1 (en) 2013-08-19 2014-08-18 Separation of bispecific antibodies and bispecific antibody production side products using hydroxyapatite chromatography

Publications (2)

Publication Number Publication Date
BR112016003196A2 BR112016003196A2 (pt) 2017-08-01
BR112016003196A8 true BR112016003196A8 (pt) 2020-02-04

Family

ID=48985686

Family Applications (1)

Application Number Title Priority Date Filing Date
BR112016003196A BR112016003196A8 (pt) 2013-08-19 2014-08-18 método para separar anticorpos biespecíficos

Country Status (11)

Country Link
US (1) US10316059B2 (pt)
EP (1) EP3036253B1 (pt)
JP (1) JP6560673B2 (pt)
KR (1) KR20160044023A (pt)
CN (2) CN105473612A (pt)
BR (1) BR112016003196A8 (pt)
CA (1) CA2919174A1 (pt)
HK (1) HK1223108A1 (pt)
MX (1) MX2016001601A (pt)
RU (1) RU2652911C2 (pt)
WO (1) WO2015024896A1 (pt)

Families Citing this family (18)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN114249831A (zh) * 2015-03-13 2022-03-29 诺夫免疫股份有限公司 纯化双特异性抗体的方法
US10520511B2 (en) * 2015-05-12 2019-12-31 Regeneron Pharmaceuticals, Inc. Multimeric protein purity determination
WO2017031476A2 (en) * 2015-08-20 2017-02-23 Genentech, Inc. Purification of fkpa and uses thereof for producing recombinant polypeptides
BR112018001511A2 (pt) * 2015-08-21 2018-09-18 Hoffmann La Roche ?uso de solução aquosa com baixa condutividade e métodos de produção e purificação de anticorpo de isótipo igg1 ou igg4 humano
WO2017032610A1 (en) * 2015-08-21 2017-03-02 F. Hoffmann-La Roche Ag Affinity chromatography purification with low conductivity wash buffer
US11186858B1 (en) 2016-03-15 2021-11-30 Fresenius Kabi Deutschland Gmbh Methods for increasing biosimilarity
EP3472177A2 (en) * 2016-06-17 2019-04-24 F. Hoffmann-La Roche AG Purification of multispecific antibodies
WO2018038469A1 (ko) * 2016-08-20 2018-03-01 (주)아이벤트러스 목적하는 이중특이성 항체의 선택적 생산 확인 방법
CN106800599B (zh) * 2016-12-05 2021-03-23 中国人民解放军第二军医大学 抗人EGFR和Notch多特异性抗体、其制备方法及用途
CA3070519A1 (en) 2017-07-21 2019-01-24 Novimmune Sa Generating multispecific antibody mixtures and methods of uses thereof
US11945839B2 (en) 2017-12-22 2024-04-02 Hoffmann-La Roche Inc. Depletion of light chain mispaired antibody variants by hydrophobic interaction chromatography
MX2020008931A (es) * 2018-02-27 2020-10-01 Pfizer Purificacion de anticuerpos.
GB201805142D0 (en) * 2018-03-29 2018-05-16 Ge Healthcare Bioprocess R&D Ab Separation method
CN109517043B (zh) * 2018-11-23 2022-06-14 艾美诚信生物制药有限公司 一种原核表达重组轮状病毒抗原p2-vp8的纯化方法
CN114409798A (zh) * 2019-02-14 2022-04-29 美勒斯公司 制备包含两种或更多种抗体的组合物
KR20210126699A (ko) * 2019-02-14 2021-10-20 메뤼스 엔.페. 2개 이상의 항체를 포함하는 조성물의 제조
CN113281430A (zh) * 2021-05-11 2021-08-20 苏州君盟生物医药科技有限公司 一种双特异性抗体的分离鉴定方法
CN116769044A (zh) * 2023-07-11 2023-09-19 康日百奥生物科技(苏州)有限公司 抗cd3和cd19双特异性抗体蛋白及其层析纯化方法

Family Cites Families (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US8093364B2 (en) 2008-01-18 2012-01-10 Bio-Rad Laboratories, Inc. Enhanced purification of antibodies and antibody fragments by apatite chromatography
CN105254758A (zh) * 2009-03-05 2016-01-20 Abbvie公司 Il-17结合蛋白
TW201138821A (en) 2010-03-26 2011-11-16 Roche Glycart Ag Bispecific antibodies
TWI426920B (zh) * 2010-03-26 2014-02-21 Hoffmann La Roche 雙專一性、雙價抗－ｖｅｇｆ／抗－ａｎｇ－２抗體
US8895707B2 (en) * 2010-08-18 2014-11-25 Bio-Rad Laboratories, Inc. Elution of proteins from hydroxyapatite resins without resin deterioration
PL3318571T3 (pl) * 2011-03-16 2021-07-05 F. Hoffmann-La Roche Ag Chromatografia jonowymienna o ulepszonej selektywności do rozdzielania monomerów, agregatów i fragmentów polipeptydowych przez modulację fazy ruchomej
WO2013088259A2 (en) * 2011-10-19 2013-06-20 Novimmune S.A. Methods of purifying antibodies

Also Published As

Publication number Publication date
CA2919174A1 (en) 2015-02-26
JP2016528268A (ja) 2016-09-15
EP3036253A1 (en) 2016-06-29
CN105473612A (zh) 2016-04-06
US20160376304A1 (en) 2016-12-29
EP3036253B1 (en) 2020-09-23
MX2016001601A (es) 2016-05-02
RU2652911C2 (ru) 2018-05-03
JP6560673B2 (ja) 2019-08-14
KR20160044023A (ko) 2016-04-22
RU2016109322A (ru) 2017-09-28
HK1223108A1 (zh) 2017-07-21
BR112016003196A2 (pt) 2017-08-01
WO2015024896A1 (en) 2015-02-26
CN118271429A (zh) 2024-07-02
US10316059B2 (en) 2019-06-11

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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 NAO 10196/2001, QUE MODIFICOU A LEI NAO 9279/96, A CONCESSAO DA PATENTE ESTA CONDICIONADA A ANUAANCIA PRA VIA DA ANVISA. CONSIDERANDO A APROVAA AO DOS TERMOS DO PARECER NAO 337/PGF/EA/2010, BEM COMO A PORTARIA INTERMINISTERIAL NAO 1065 DE 24/05/2012, ENCAMINHA-SE O PRESENTE PEDIDO PARA AS PROVIDAANCIAS CABA-VEIS.

B07E Notification of approval relating to section 229 industrial property law [chapter 7.5 patent gazette]
B06U Preliminary requirement: requests with searches performed by other patent offices: procedure suspended [chapter 6.21 patent gazette]
B11B Dismissal acc. art. 36, par 1 of ipl - no reply within 90 days to fullfil the necessary requirements