BR112016003196A8 - método para separar anticorpos biespecíficos - Google Patents
método para separar anticorpos biespecíficos Download PDFInfo
- 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
- Authority
- BR
- Brazil
- Prior art keywords
- antibody
- bispecific antibody
- bispecific antibodies
- bispecific
- products
- Prior art date
Links
- 238000000034 method Methods 0.000 title abstract 4
- 239000006227 byproduct Substances 0.000 abstract 3
- 238000004587 chromatography analysis Methods 0.000 abstract 2
- 239000012634 fragment Substances 0.000 abstract 2
- 229910052588 hydroxylapatite Inorganic materials 0.000 abstract 2
- 238000004519 manufacturing process Methods 0.000 abstract 2
- XYJRXVWERLGGKC-UHFFFAOYSA-D pentacalcium;hydroxide;triphosphate Chemical compound [OH-].[Ca+2].[Ca+2].[Ca+2].[Ca+2].[Ca+2].[O-]P([O-])([O-])=O.[O-]P([O-])([O-])=O.[O-]P([O-])([O-])=O XYJRXVWERLGGKC-UHFFFAOYSA-D 0.000 abstract 2
- 239000000427 antigen Substances 0.000 abstract 1
- 102000036639 antigens Human genes 0.000 abstract 1
- 108091007433 antigens Proteins 0.000 abstract 1
- 238000003745 diagnosis Methods 0.000 abstract 1
- 238000000746 purification Methods 0.000 abstract 1
- 238000000926 separation method Methods 0.000 abstract 1
- 230000001225 therapeutic effect Effects 0.000 abstract 1
- 238000010977 unit operation Methods 0.000 abstract 1
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
- C07K1/16—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
Landscapes
- 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.
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)
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)
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 |
-
2014
- 2014-08-18 WO PCT/EP2014/067552 patent/WO2015024896A1/en active Application Filing
- 2014-08-18 KR KR1020167007112A patent/KR20160044023A/ko not_active Application Discontinuation
- 2014-08-18 CA CA2919174A patent/CA2919174A1/en not_active Abandoned
- 2014-08-18 CN CN201480045853.5A patent/CN105473612A/zh active Pending
- 2014-08-18 RU RU2016109322A patent/RU2652911C2/ru active
- 2014-08-18 JP JP2016535445A patent/JP6560673B2/ja active Active
- 2014-08-18 EP EP14761965.4A patent/EP3036253B1/en active Active
- 2014-08-18 CN CN202410455212.2A patent/CN118271429A/zh active Pending
- 2014-08-18 BR BR112016003196A patent/BR112016003196A8/pt not_active Application Discontinuation
- 2014-08-18 MX MX2016001601A patent/MX2016001601A/es unknown
-
2016
- 2016-02-19 US US15/048,308 patent/US10316059B2/en active Active
- 2016-09-27 HK HK16111307.7A patent/HK1223108A1/zh unknown
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. |
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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 |