CA2806314C - Method for purifying active polypeptides or immunoconjugates - Google Patents

Method for purifying active polypeptides or immunoconjugates Download PDF

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Publication number
CA2806314C
CA2806314C CA2806314A CA2806314A CA2806314C CA 2806314 C CA2806314 C CA 2806314C CA 2806314 A CA2806314 A CA 2806314A CA 2806314 A CA2806314 A CA 2806314A CA 2806314 C CA2806314 C CA 2806314C
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Canada
Prior art keywords
gly
ala
leu
polypeptide
ser
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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.)
Active
Application number
CA2806314A
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English (en)
French (fr)
Other versions
CA2806314A1 (en
Inventor
Thomas Linke
William K. Wang
Ambarish Shah
Hasige Sathish
Alan Hunter
Christopher Thompson
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MedImmune LLC
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MedImmune LLC
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
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Publication of CA2806314A1 publication Critical patent/CA2806314A1/en
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Publication of CA2806314C publication Critical patent/CA2806314C/en
Active legal-status Critical Current
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Classifications

    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
    • C07K16/18—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/28—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/2851—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against the lectin superfamily, e.g. CD23, CD72
    • 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
    • A61K39/39533—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals
    • A61K39/3955—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals against proteinaceous materials, e.g. enzymes, hormones, lymphokines
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/02—Inorganic compounds
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/50—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
    • A61K47/51—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent
    • A61K47/68—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an antibody, an immunoglobulin or a fragment thereof, e.g. an Fc-fragment
    • A61K47/6801—Drug-antibody or immunoglobulin conjugates defined by the pharmacologically or therapeutically active agent
    • A61K47/6803—Drugs conjugated to an antibody or immunoglobulin, e.g. cisplatin-antibody conjugates
    • A61K47/6811—Drugs conjugated to an antibody or immunoglobulin, e.g. cisplatin-antibody conjugates the drug being a protein or peptide, e.g. transferrin or bleomycin
    • A61K47/6817—Toxins
    • A61K47/6829—Bacterial toxins, e.g. diphteria toxins or Pseudomonas exotoxin A
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/50—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
    • A61K47/51—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent
    • A61K47/68—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an antibody, an immunoglobulin or a fragment thereof, e.g. an Fc-fragment
    • A61K47/6835—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an antibody, an immunoglobulin or a fragment thereof, e.g. an Fc-fragment the modifying agent being an antibody or an immunoglobulin bearing at least one antigen-binding site
    • A61K47/6849—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an antibody, an immunoglobulin or a fragment thereof, e.g. an Fc-fragment the modifying agent being an antibody or an immunoglobulin bearing at least one antigen-binding site the antibody targeting a receptor, a cell surface antigen or a cell surface determinant
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P39/00—General protective or antinoxious agents
    • A61P39/02—Antidotes
    • 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
    • B01D15/10—Selective adsorption, e.g. chromatography characterised by constructional or operational features
    • B01D15/16—Selective adsorption, e.g. chromatography characterised by constructional or operational features relating to the conditioning of the fluid carrier
    • B01D15/166—Fluid composition conditioning, e.g. gradient
    • 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, e.g. ion-exchange, ion-pair, ion-suppression or ion-exclusion
    • B01D15/361—Ion-exchange
    • B01D15/363—Anion-exchange
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01J—CHEMICAL OR PHYSICAL PROCESSES, e.g. CATALYSIS OR COLLOID CHEMISTRY; THEIR RELEVANT APPARATUS
    • B01J41/00—Anion exchange; Use of material as anion exchangers; Treatment of material for improving the anion exchange properties
    • B01J41/08—Use of material as anion exchangers; Treatment of material for improving the anion exchange properties
    • B01J41/12—Macromolecular compounds
    • B01J41/14—Macromolecular compounds obtained by reactions only involving unsaturated carbon-to-carbon bonds
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01J—CHEMICAL OR PHYSICAL PROCESSES, e.g. CATALYSIS OR COLLOID CHEMISTRY; THEIR RELEVANT APPARATUS
    • B01J41/00—Anion exchange; Use of material as anion exchangers; Treatment of material for improving the anion exchange properties
    • B01J41/20—Anion exchangers for chromatographic processes
    • 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
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
    • C07K16/18—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/28—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/2803—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against the immunoglobulin superfamily
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K17/00—Carrier-bound or immobilised peptides; Preparation thereof
    • C07K17/02—Peptides being immobilised on, or in, an organic carrier
    • 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
    • A61K2039/505—Medicinal preparations containing antigens or antibodies comprising antibodies
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/50—Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/56—Immunoglobulins specific features characterized by immunoglobulin fragments variable (Fv) region, i.e. VH and/or VL
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/90—Immunoglobulins specific features characterized by (pharmaco)kinetic aspects or by stability of the immunoglobulin
    • C07K2317/94—Stability, e.g. half-life, pH, temperature or enzyme-resistance
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2319/00—Fusion polypeptide
    • C07K2319/35—Fusion polypeptide containing a fusion for enhanced stability/folding during expression, e.g. fusions with chaperones or thioredoxin
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2319/00—Fusion polypeptide
    • C07K2319/55—Fusion polypeptide containing a fusion with a toxin, e.g. diphteria toxin

Landscapes

  • Chemical & Material Sciences (AREA)
  • Health & Medical Sciences (AREA)
  • Organic Chemistry (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Immunology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Analytical Chemistry (AREA)
  • Molecular Biology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Genetics & Genomics (AREA)
  • Biochemistry (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Biophysics (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Toxicology (AREA)
  • Cell Biology (AREA)
  • Mycology (AREA)
  • Microbiology (AREA)
  • Inorganic Chemistry (AREA)
  • Endocrinology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Peptides Or Proteins (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Preparation Of Compounds By Using Micro-Organisms (AREA)
  • Medicinal Preparation (AREA)
CA2806314A 2010-07-30 2011-07-27 Method for purifying active polypeptides or immunoconjugates Active CA2806314C (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US36914810P 2010-07-30 2010-07-30
US61/369,148 2010-07-30
PCT/US2011/045524 WO2012015912A1 (en) 2010-07-30 2011-07-27 Method for purifying active polypeptides or immunocojugates

Publications (2)

Publication Number Publication Date
CA2806314A1 CA2806314A1 (en) 2012-07-02
CA2806314C true CA2806314C (en) 2019-09-24

Family

ID=45530485

Family Applications (1)

Application Number Title Priority Date Filing Date
CA2806314A Active CA2806314C (en) 2010-07-30 2011-07-27 Method for purifying active polypeptides or immunoconjugates

Country Status (16)

Country Link
US (5) US9580461B2 (enExample)
EP (3) EP3797847A1 (enExample)
JP (1) JP6061853B2 (enExample)
CN (1) CN103079666B (enExample)
BR (1) BR112013002334A2 (enExample)
CA (1) CA2806314C (enExample)
DK (1) DK3434346T3 (enExample)
ES (2) ES2678204T3 (enExample)
HU (2) HUE051702T2 (enExample)
LT (2) LT3434346T (enExample)
MX (1) MX342920B (enExample)
NO (1) NO2021030I1 (enExample)
PL (1) PL3434346T3 (enExample)
PT (1) PT3434346T (enExample)
SG (3) SG187587A1 (enExample)
WO (1) WO2012015912A1 (enExample)

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BR112013002334A2 (pt) 2010-07-30 2016-05-24 Medimmune Llc método para purificar polipeptídeos ou imunoconjugados ativos.
CA2815342A1 (en) * 2010-10-20 2012-04-26 Medimmune, Llc Methods for processing inclusion bodies
SG11201407809QA (en) 2012-05-31 2014-12-30 Agency Science Tech & Res Chromatographic purification of immunoglobulin g preparations with particles having multimodal functionalities
CN105007937B (zh) * 2012-12-20 2019-11-19 米迪缪尼有限公司 生产免疫偶联物的方法
GB201412658D0 (en) 2014-07-16 2014-08-27 Ucb Biopharma Sprl Molecules
KR101531479B1 (ko) * 2014-11-21 2015-06-26 세원셀론텍(주) 의료용 재료로 사용하기 위한 고농도 콜라겐 제조방법
EP3280444B1 (en) * 2015-04-10 2024-05-08 Adimab, LLC Methods for purifying heterodimeric multispecific antibodies from parental homodimeric antibody species
GB201601077D0 (en) 2016-01-20 2016-03-02 Ucb Biopharma Sprl Antibody molecule
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GB201601073D0 (en) 2016-01-20 2016-03-02 Ucb Biopharma Sprl Antibodies
JP7217700B2 (ja) 2016-09-13 2023-02-03 アラーガン、インコーポレイテッド 安定化非タンパク質クロストリジウム毒素組成物
WO2018075357A1 (en) * 2016-10-17 2018-04-26 Duke University PRODUCTION OF IMMUNOTOXIN D2C7-(scdsFv)-PE38KDEL
WO2018092885A1 (ja) 2016-11-18 2018-05-24 アステラス製薬株式会社 新規な抗ヒトＭＵＣ１抗体Ｆａｂフラグメント
WO2018187388A1 (en) * 2017-04-04 2018-10-11 Scarab Genomics, Llc Improved purification of crm 197 from bacteria
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US20200239575A1 (en) * 2017-10-06 2020-07-30 University Of Utah Research Foundation A fusion protein for targeted therapy of autoimmune disease
WO2019071150A1 (en) * 2017-10-06 2019-04-11 University Of Utah Research Foundation FUSION PROTEIN FOR TARGETED THERAPY OF AUTOIMMUNE DISEASE
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MX2021004146A (es) 2018-10-10 2021-06-08 Astellas Pharma Inc Composicion farmaceutica que contiene complejo de fragmento fab de anticuerpo antihumano con sitio marcado.
US12514927B2 (en) 2019-10-30 2026-01-06 Duke University Immunotherapy with combination therapy comprising an immunotoxin
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EP4175969A4 (en) * 2020-07-01 2024-07-24 Medimmune, LLC DETERGENT AND METHOD FOR PURIFYING A BIOTHERAPY AGENT

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Also Published As

Publication number Publication date
SG10202009967TA (en) 2020-11-27
DK3434346T3 (da) 2020-12-07
MX342920B (es) 2016-10-19
SG10201506030RA (en) 2015-09-29
US9580461B2 (en) 2017-02-28
HUS2100027I1 (hu) 2021-07-28
ES2836447T3 (es) 2021-06-25
MX2013001044A (es) 2013-06-05
EP2613857A4 (en) 2015-01-14
EP2613857B1 (en) 2018-05-30
JP6061853B2 (ja) 2017-01-18
HUE051702T2 (hu) 2021-03-29
ES2678204T3 (es) 2018-08-09
US20180371094A1 (en) 2018-12-27
CN103079666B (zh) 2017-10-24
US20210395370A1 (en) 2021-12-23
AU2011282774B2 (en) 2016-05-26
CA2806314A1 (en) 2012-07-02
EP3434346B1 (en) 2020-09-02
LT3434346T (lt) 2020-12-28
BR112013002334A2 (pt) 2016-05-24
EP3797847A1 (en) 2021-03-31
US20200231680A1 (en) 2020-07-23
EP3434346A1 (en) 2019-01-30
US10072083B2 (en) 2018-09-11
PL3434346T3 (pl) 2021-04-06
AU2011282774A1 (en) 2013-01-31
US20170145100A1 (en) 2017-05-25
PT3434346T (pt) 2020-11-26
LTPA2021517I1 (enExample) 2021-08-25
EP2613857A1 (en) 2013-07-17
SG187587A1 (en) 2013-03-28
US20130202626A1 (en) 2013-08-08
JP2013534217A (ja) 2013-09-02
CN103079666A (zh) 2013-05-01
US11136396B2 (en) 2021-10-05
US10556955B2 (en) 2020-02-11
WO2012015912A1 (en) 2012-02-02
NO2021030I1 (no) 2021-07-15

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