MX2016001601A - Separacion de anticuerpos biespecificos y subproductos de produccion de anticuerpos biespecificos utilizando cromatografia de hidroxiapatita. - Google Patents

Separacion de anticuerpos biespecificos y subproductos de produccion de anticuerpos biespecificos utilizando cromatografia de hidroxiapatita.

Info

Publication number
MX2016001601A
MX2016001601A MX2016001601A MX2016001601A MX2016001601A MX 2016001601 A MX2016001601 A MX 2016001601A MX 2016001601 A MX2016001601 A MX 2016001601A MX 2016001601 A MX2016001601 A MX 2016001601A MX 2016001601 A MX2016001601 A MX 2016001601A
Authority
MX
Mexico
Prior art keywords
bispecific antibody
bispecific
hydroxyapatite chromatography
separation
byproducts
Prior art date
Application number
MX2016001601A
Other languages
English (en)
Inventor
Harald Duerr
Sabine Bertl
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 MX2016001601A publication Critical patent/MX2016001601A/es

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
    • C07K1/16—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

La presente descripción se refiere a métodos que comprenden el uso de cromatografía de hidroxiapatita para separar un anticuerpo biespecífico de una solución que comprende también uno o más subproductos específicos para la producción de anticuerpos biespecíficos. Subproductos específicos para la producción de anticuerpos biespecíficos (subproductos específicos de anticuerpos biespecíficos, ``BASB´´) incluyen fragmentos del anticuerpo biespecífico y variantes de peso molecular más pesado del anticuerpo, en donde el fragmento y/o variante comprende un dominio Fc pero no exhibe afinidad para los dos epítopos y/o antígenos como es exhibido por el anticuerpo biespecífico deseado diferente. Por lo tanto, los métodos de la presente descripción comprenden la separación de un anticuerpo biespecífico de uno o más de sus BASB. Los métodos de cromatografía de hidroxiapatita de la descripción pueden usarse solos o pueden combinarse adicionalmente con los procesos de purificación estándar y operaciones de unidad como se conoce en la técnica para conseguir cualquier nivel de pureza del anticuerpo biespecífico necesario, por ejemplo, para aplicaciones y/o de diagnóstico terapéutico.
MX2016001601A 2013-08-19 2014-08-18 Separacion de anticuerpos biespecificos y subproductos de produccion de anticuerpos biespecificos utilizando cromatografia de hidroxiapatita. MX2016001601A (es)

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 (1)

Publication Number Publication Date
MX2016001601A true MX2016001601A (es) 2016-05-02

Family

ID=48985686

Family Applications (1)

Application Number Title Priority Date Filing Date
MX2016001601A MX2016001601A (es) 2013-08-19 2014-08-18 Separacion de anticuerpos biespecificos y subproductos de produccion de anticuerpos biespecificos utilizando cromatografia de hidroxiapatita.

Country Status (11)

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

Families Citing this family (16)

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US10457749B2 (en) * 2015-03-13 2019-10-29 Novimmune Sa Methods of purifying bispecific antibodies
MX2018002068A (es) * 2015-08-20 2018-06-06 Genentech Inc Purificacion de fkpa y usos de la misma para producir polipeptidos recombinantes.
ES2877532T3 (es) * 2015-08-21 2021-11-17 Hoffmann La Roche Procedimiento para la reducción de proteínas de célula huésped en cromatografía de afinidad
JP7084301B2 (ja) * 2015-08-21 2022-06-14 エフ．ホフマン－ラ ロシュ アーゲー 低伝導率洗浄緩衝液を用いたアフィニティークロマトグラフィー精製方法
US11186858B1 (en) 2016-03-15 2021-11-30 Fresenius Kabi Deutschland Gmbh Methods for increasing biosimilarity
TWI798179B (zh) * 2016-06-17 2023-04-11 美商建南德克公司 多特異性抗體之純化
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
CN111201238B (zh) 2017-07-21 2023-09-08 诺夫免疫股份有限公司 产生多特异性抗体混合物及其使用方法
CN111491951B (zh) * 2017-12-22 2024-05-24 豪夫迈·罗氏有限公司 通过疏水相互作用色谱法耗尽轻链错配的抗体变体
JP7449041B2 (ja) * 2018-02-27 2024-03-13 ファイザー・インク 抗体精製
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
AU2020221649A1 (en) * 2019-02-14 2021-09-02 Merus N.V. Producing compositions comprising two or more antibodies.
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

Family Cites Families (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP5624476B2 (ja) 2008-01-18 2014-11-12 バイオ−ラッド ラボラトリーズ インコーポレーティッド アパタイトクロマトグラフィーによるリン酸化生体分子および非リン酸化生体分子の向上した精製法
EP2810652A3 (en) * 2009-03-05 2015-03-11 AbbVie Inc. IL-17 binding proteins
AR080794A1 (es) * 2010-03-26 2012-05-09 Hoffmann La Roche Anticuerpos bivalentes biespecificos anti- vegf/ anti-ang-2
AR080793A1 (es) 2010-03-26 2012-05-09 Roche Glycart Ag Anticuerpos biespecificos
US8895707B2 (en) * 2010-08-18 2014-11-25 Bio-Rad Laboratories, Inc. Elution of proteins from hydroxyapatite resins without resin deterioration
SG193378A1 (en) * 2011-03-16 2013-10-30 Hoffmann La Roche Ion exchange chromatography with improved selectivity for the separation of polypeptide monomers, aggregates and fragments by modulation of the mobile phase
PT2768857T (pt) * 2011-10-19 2020-01-27 Novimmune Sa Métodos para purificar anticorpos

Also Published As

Publication number Publication date
CA2919174A1 (en) 2015-02-26
EP3036253A1 (en) 2016-06-29
US20160376304A1 (en) 2016-12-29
BR112016003196A8 (pt) 2020-02-04
WO2015024896A1 (en) 2015-02-26
HK1223108A1 (zh) 2017-07-21
EP3036253B1 (en) 2020-09-23
US10316059B2 (en) 2019-06-11
RU2016109322A (ru) 2017-09-28
RU2652911C2 (ru) 2018-05-03
JP6560673B2 (ja) 2019-08-14
KR20160044023A (ko) 2016-04-22
BR112016003196A2 (pt) 2017-08-01
JP2016528268A (ja) 2016-09-15
CN105473612A (zh) 2016-04-06

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