SG11202005541QA - Methods for antibody drug conjugation, purification, and formulation - Google Patents

Methods for antibody drug conjugation, purification, and formulation

Info

Publication number
SG11202005541QA
SG11202005541QA SG11202005541QA SG11202005541QA SG11202005541QA SG 11202005541Q A SG11202005541Q A SG 11202005541QA SG 11202005541Q A SG11202005541Q A SG 11202005541QA SG 11202005541Q A SG11202005541Q A SG 11202005541QA SG 11202005541Q A SG11202005541Q A SG 11202005541QA
Authority
SG
Singapore
Prior art keywords
formulation
purification
methods
antibody drug
drug conjugation
Prior art date
Application number
SG11202005541QA
Other languages
English (en)
Inventor
Daniel F Milano
Michael R Reardon
Richard A Silva
Benjamin M Hutchins
Robert W Herbst
Original Assignee
Immunogen 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 Immunogen Inc filed Critical Immunogen Inc
Publication of SG11202005541QA publication Critical patent/SG11202005541QA/en

Links

Classifications

    • 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
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/535—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with at least one nitrogen and one oxygen as the ring hetero atoms, e.g. 1,2-oxazines
    • A61K31/5365—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with at least one nitrogen and one oxygen as the ring hetero atoms, e.g. 1,2-oxazines ortho- or peri-condensed with heterocyclic ring systems
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/535—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with at least one nitrogen and one oxygen as the ring hetero atoms, e.g. 1,2-oxazines
    • A61K31/5375—1,4-Oxazines, e.g. morpholine
    • A61K31/5383—1,4-Oxazines, e.g. morpholine ortho- or peri-condensed with heterocyclic ring systems
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/55—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having seven-membered rings, e.g. azelastine, pentylenetetrazole
    • A61K31/551—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having seven-membered rings, e.g. azelastine, pentylenetetrazole having two nitrogen atoms, e.g. dilazep
    • A61K31/5513—1,4-Benzodiazepines, e.g. diazepam or clozapine
    • A61K31/5517—1,4-Benzodiazepines, e.g. diazepam or clozapine condensed with five-membered rings having nitrogen as a ring hetero atom, e.g. imidazobenzodiazepines, triazolam
    • 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
    • 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
    • A61K47/68033—Drugs conjugated to an antibody or immunoglobulin, e.g. cisplatin-antibody conjugates the drug being a maytansine
    • 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
    • A61K47/68035—Drugs conjugated to an antibody or immunoglobulin, e.g. cisplatin-antibody conjugates the drug being a pyrrolobenzodiazepine
    • 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
    • A61K47/6889—Conjugates wherein the antibody being the modifying agent and wherein the linker, binder or spacer confers particular properties to the conjugates, e.g. peptidic enzyme-labile linkers or acid-labile linkers, providing for an acid-labile immuno conjugate wherein the drug may be released from its antibody conjugated part in an acidic, e.g. tumoural or environment
    • 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
    • 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
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/68—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving proteins, peptides or amino acids
    • G01N33/6854—Immunoglobulins
    • 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

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Immunology (AREA)
  • Organic Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Epidemiology (AREA)
  • Molecular Biology (AREA)
  • Biochemistry (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Biophysics (AREA)
  • Genetics & Genomics (AREA)
  • Analytical Chemistry (AREA)
  • Cell Biology (AREA)
  • Biomedical Technology (AREA)
  • Urology & Nephrology (AREA)
  • Hematology (AREA)
  • Water Supply & Treatment (AREA)
  • Microbiology (AREA)
  • Biotechnology (AREA)
  • Food Science & Technology (AREA)
  • Physics & Mathematics (AREA)
  • General Physics & Mathematics (AREA)
  • Pathology (AREA)
  • Peptides Or Proteins (AREA)
  • Medicinal Preparation (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Preparation Of Compounds By Using Micro-Organisms (AREA)
SG11202005541QA 2018-01-12 2019-01-11 Methods for antibody drug conjugation, purification, and formulation SG11202005541QA (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US201862617021P 2018-01-12 2018-01-12
US201862673535P 2018-05-18 2018-05-18
PCT/US2019/013120 WO2019140141A1 (fr) 2018-01-12 2019-01-11 Procédés de production, purification et formulation de conjugués anticorps-médicaments

Publications (1)

Publication Number Publication Date
SG11202005541QA true SG11202005541QA (en) 2020-07-29

Family

ID=67219931

Family Applications (1)

Application Number Title Priority Date Filing Date
SG11202005541QA SG11202005541QA (en) 2018-01-12 2019-01-11 Methods for antibody drug conjugation, purification, and formulation

Country Status (12)

Country Link
US (2) US11274121B2 (fr)
EP (1) EP3737421A4 (fr)
JP (2) JP7474195B2 (fr)
KR (1) KR20200108843A (fr)
CN (1) CN111587125A (fr)
AU (1) AU2019206587A1 (fr)
CA (1) CA3087993A1 (fr)
IL (1) IL275798A (fr)
MA (1) MA51629A (fr)
SG (1) SG11202005541QA (fr)
TW (1) TW201934187A (fr)
WO (1) WO2019140141A1 (fr)

Families Citing this family (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
SG10201907501QA (en) 2013-08-30 2019-10-30 Immunogen Inc Antibodies and assays for detection of folate receptor 1
CN107592813A (zh) * 2014-11-19 2018-01-16 伊缪诺金公司 用于制备细胞结合剂‑细胞毒性剂缀合物的方法
EP3313884B9 (fr) 2015-06-29 2021-05-19 ImmunoGen, Inc. Anticorps anti-cd 123 et conjugués et dérivés correspondants
US20200254112A1 (en) * 2017-08-14 2020-08-13 Fujirebio Diagnostics, Inc. Antibody conjugation method
TW202102270A (zh) * 2019-03-21 2021-01-16 美商伊繆諾金公司 製備細胞結合劑-藥物結合物之方法
JP2022530524A (ja) 2019-04-29 2022-06-29 イミュノジェン， インコーポレイテッド バイパラトピックＦＲ－α抗体及びイムノコンジュゲート
EP3939691B1 (fr) 2020-07-13 2023-11-22 Sartorius Stedim Biotech GmbH Dispositif d'assemblage de production de bio-conjugués
EP4153241A4 (fr) * 2021-02-09 2023-12-06 Genequantum Healthcare (Suzhou) Co., Ltd. Dispositif et procédé de conjugaison pour la production de conjugués
TW202306995A (zh) * 2021-06-04 2023-02-16 美商免疫遺傳股份有限公司 治療具有可溶性ＦＲ－α之患者之癌症
JPWO2023038067A1 (fr) * 2021-09-08 2023-03-16

Family Cites Families (18)

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Publication number Priority date Publication date Assignee Title
PL1928503T3 (pl) 2005-08-24 2012-12-31 Immunogen Inc Sposób wytwarzania koniugatów majtazynoid-przeciwciało
KR20100137585A (ko) * 2008-04-30 2010-12-30 이뮤노젠 아이엔씨 강력한 복합체 및 친수성 링커
LT2437790T (lt) 2009-06-03 2019-06-10 Immunogen, Inc. Konjugavimo būdai
DK2538976T3 (en) 2010-02-24 2017-02-27 Immunogen Inc IMMUNCONJUGATES AGAINST FOLATRECEPTOR-1 AND APPLICATIONS THEREOF
EP3666289A1 (fr) * 2011-02-15 2020-06-17 ImmunoGen, Inc. Dérivés de benzodiazépine cytotoxique
WO2012135522A2 (fr) 2011-03-29 2012-10-04 Immunogen, Inc. Procédé et fabrication de conjugués d'homogénéité améliorée
EP2524929A1 (fr) 2011-05-17 2012-11-21 Sanofi Utilisation d'anticorps immunoconjugués anti-CD19 maytansinoïdes pour le traitement de symptômes de malignités CD19+lymphocytes B
US20150306242A1 (en) * 2012-10-04 2015-10-29 Immunogen, Inc. Process for preparing stable antibody maytansinoid conjugates
SG10201901555UA (en) * 2014-08-29 2019-03-28 Emd Millipore Corp Single Pass Tangential Flow Filtration Systems and Tangential Flow Filtration Systems withRecirculation of Retentate
WO2016036861A1 (fr) * 2014-09-02 2016-03-10 Immunogen, Inc. Procédés de formulation de compositions de conjugués anticorps-médicaments
SG10201901825YA (en) * 2014-09-03 2019-03-28 Immunogen Inc Conjugates comprising cell-binding agents and cytotoxic agents
EP3313884B9 (fr) 2015-06-29 2021-05-19 ImmunoGen, Inc. Anticorps anti-cd 123 et conjugués et dérivés correspondants
WO2017174580A1 (fr) * 2016-04-04 2017-10-12 Boehringer Ingelheim Rcv Gmbh & Co Kg Surveillance en temps réel de purification de produit
ES2925059T3 (es) * 2016-06-09 2022-10-13 Emd Millipore Corp Elementos de filtro de trayectoria radial, sistemas y métodos de uso de los mismos
TWI783957B (zh) 2016-12-23 2022-11-21 美商伊繆諾金公司 靶向adam9之免疫共軛物及其使用方法
TW201825515A (zh) 2017-01-04 2018-07-16 美商伊繆諾金公司 Ｍｅｔ抗體以及其免疫結合物及用途
MA49152A (fr) 2017-05-17 2020-03-25 Immunogen Inc Schémas posologiques d'immunoconjugués anti-cd33
EP3431168A1 (fr) * 2017-07-19 2019-01-23 Bayer Aktiengesellschaft Élimination de médicament non lié après accouplement conjugué anticorps-médicament

Also Published As

Publication number Publication date
JP2021510694A (ja) 2021-04-30
JP7474195B2 (ja) 2024-04-24
US20190270769A1 (en) 2019-09-05
EP3737421A4 (fr) 2022-03-16
US11274121B2 (en) 2022-03-15
US20220267371A1 (en) 2022-08-25
RU2020121946A (ru) 2022-03-10
IL275798A (en) 2020-08-31
MA51629A (fr) 2020-11-18
KR20200108843A (ko) 2020-09-21
CN111587125A (zh) 2020-08-25
EP3737421A1 (fr) 2020-11-18
JP2024019597A (ja) 2024-02-09
TW201934187A (zh) 2019-09-01
WO2019140141A1 (fr) 2019-07-18
CA3087993A1 (fr) 2019-07-18
AU2019206587A1 (en) 2020-08-06

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