HRP20120794T1 - Postupak za pripremu proäśišä†enih konjugata lijeka - Google Patents
Postupak za pripremu proäśišä†enih konjugata lijeka Download PDFInfo
- Publication number
- HRP20120794T1 HRP20120794T1 HRP20120794TT HRP20120794T HRP20120794T1 HR P20120794 T1 HRP20120794 T1 HR P20120794T1 HR P20120794T T HRP20120794T T HR P20120794TT HR P20120794 T HRP20120794 T HR P20120794T HR P20120794 T1 HRP20120794 T1 HR P20120794T1
- Authority
- HR
- Croatia
- Prior art keywords
- antibody
- maytansinoid
- mixture
- solution
- bonds
- Prior art date
Links
- 229940127121 immunoconjugate Drugs 0.000 title 1
- 238000004519 manufacturing process Methods 0.000 title 1
- 238000000034 method Methods 0.000 claims 15
- 239000000203 mixture Substances 0.000 claims 9
- 239000000243 solution Substances 0.000 claims 6
- 238000009295 crossflow filtration Methods 0.000 claims 3
- 230000000274 adsorptive effect Effects 0.000 claims 2
- 229960000575 trastuzumab Drugs 0.000 claims 2
- 108090000371 Esterases Proteins 0.000 claims 1
- 108091005804 Peptidases Proteins 0.000 claims 1
- 102000035195 Peptidases Human genes 0.000 claims 1
- CZMRCDWAGMRECN-UGDNZRGBSA-N Sucrose Chemical compound O[C@H]1[C@H](O)[C@@H](CO)O[C@@]1(CO)O[C@@H]1[C@H](O)[C@@H](O)[C@H](O)[C@@H](CO)O1 CZMRCDWAGMRECN-UGDNZRGBSA-N 0.000 claims 1
- 229930006000 Sucrose Natural products 0.000 claims 1
- 239000008351 acetate buffer Substances 0.000 claims 1
- 239000002253 acid Substances 0.000 claims 1
- 230000001588 bifunctional effect Effects 0.000 claims 1
- 229950002903 bivatuzumab Drugs 0.000 claims 1
- 239000006172 buffering agent Substances 0.000 claims 1
- 239000006227 byproduct Substances 0.000 claims 1
- 238000006243 chemical reaction Methods 0.000 claims 1
- 239000007979 citrate buffer Substances 0.000 claims 1
- 230000001268 conjugating effect Effects 0.000 claims 1
- 239000003431 cross linking reagent Substances 0.000 claims 1
- 238000001914 filtration Methods 0.000 claims 1
- 239000008363 phosphate buffer Substances 0.000 claims 1
- 238000001556 precipitation Methods 0.000 claims 1
- 238000002360 preparation method Methods 0.000 claims 1
- 235000019833 protease Nutrition 0.000 claims 1
- 239000011347 resin Substances 0.000 claims 1
- 229920005989 resin Polymers 0.000 claims 1
- 229960004641 rituximab Drugs 0.000 claims 1
- 229950008684 sibrotuzumab Drugs 0.000 claims 1
- 239000000126 substance Substances 0.000 claims 1
- 239000008362 succinate buffer Substances 0.000 claims 1
- 239000005720 sucrose Substances 0.000 claims 1
- 125000003396 thiol group Chemical group [H]S* 0.000 claims 1
Classifications
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- 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
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K38/00—Medicinal preparations containing peptides
- A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
- A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
- A61K38/19—Cytokines; Lymphokines; Interferons
- A61K38/20—Interleukins [IL]
-
- 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
-
- 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
- A61K47/6851—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 determinant of a tumour cell
- A61K47/6867—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 determinant of a tumour cell the tumour determinant being from a cell of a blood cancer
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P35/00—Antineoplastic agents
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
-
- 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
- C07K16/2896—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against molecules with a "CD"-designation, not provided for elsewhere
-
- 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
- A61K47/6807—Drugs conjugated to an antibody or immunoglobulin, e.g. cisplatin-antibody conjugates the drug or compound being a sugar, nucleoside, nucleotide, nucleic acid, e.g. RNA antisense
- A61K47/6809—Antibiotics, e.g. antitumor antibiotics anthracyclins, adriamycin, doxorubicin or daunomycin
-
- 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
- C07K16/2839—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 integrin superfamily
-
- 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
- C07K16/2884—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against CD44
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K2317/00—Immunoglobulins specific features
- C07K2317/20—Immunoglobulins specific features characterized by taxonomic origin
- C07K2317/24—Immunoglobulins specific features characterized by taxonomic origin containing regions, domains or residues from different species, e.g. chimeric, humanized or veneered
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K2317/00—Immunoglobulins specific features
- C07K2317/40—Immunoglobulins specific features characterized by post-translational modification
Claims (15)
1. Postupak za pripremu konjugata antitijela i maitanzinoida koji sadrži korake:
(a) dovođenja u dodir antitijela sa bifunkcionalnim unakrsno-vezujućim reagensom da bi se linker kovalentno vezao za antitijelo i na taj način pripremila prva smjesa koja sadrži antitijela koja imaju za sebe vezane linkere,
(b) podvrgavanja prve smjese filtraciji sa tangencijalnim protokom, selektivnom taloženju, adsorptivnoj filtraciji ili adsorptivnoj kromatografskoj smoli i na taj način priprema pročišćene prve smjese antitijela koja imaju za sebe vezane linkere,
(c) konjugacije maitanzinoida sa antitijelima koja imaju za sebe vezane linkere u pročišćenoj prvoj smjesi putem reakcije antitijela koja imaju za sebe vezane linkere sa maitanzinoidom u otopini koja ima pH od 4 do 9 da bi se pripremila druga smjesa koja sadrži (i) antitijelo kemijski spojeno preko linkera za maitanzinoid, (ii) slobodan maitanzinoid i (iii) sporedne proizvode reakcije, i
(d) podvrgavanja druge smjese filtraciji sa tangencijalnim protokom da bi se pročistila antitijela kemijski spojena preko linkera za maitanzinoid od drugih komponenti druge smjese i na taj način pripremila pročišćena druga smjesa antitijela koja su kemijski spojena preko linkera za maitanzinoid.
2. Postupak prema patentnom zahtjevu 1, naznačen time što otopina u koraku (c) ima pH od 4 do 6.0.
3. Postupak prema patentnom zahtjevu 1, naznačen time što otopina u koraku (c) ima pH od 6.5 do 9.
4. Postupak prema patentnom zahtjevu 1, naznačen time što otopina u koraku (c) ima pH od manje od 6.0 ili pH od više od 6.5.
5. Postupak prema bilo kojem od patentnih zahtjeva 1-4, naznačen time što otopina u koraku (c) sadrži saharozu.
6. Postupak prema bilo kojem od patentnih zahtjeva 1-5, naznačen time što otopina u koraku (c) dalje sadrži puferirajuće sredstvo izabrano iz grupe koju čine citratni pufer, acetatni pufer, sukcinatni pufer i fosfatni pufer.
7. Postupak prema bilo kojem od patentnih zahtjeva 1-6, naznačen time što je antitijelo monoklonalno antitijelo.
8. Postupak prema patentnom zahtjevu 7, naznačen time što je antitijelo humanizirano monoklonalno antitijelo.
9. Postupak prema patentnom zahtjevu 8, naznačen time što je antitijelo izabrano iz grupe koju čine huN901, huMy9-6, huB4, huC242, trastuzumab, bivatuzumab, sibrotuzumab, CNTO95, huDS6 i rituksimab.
10. Postupak prema patentnom zahtjevu 9, naznačen time što je antitijelo trastuzumab.
11. Postupak prema bilo kojem od patentnih zahtjeva 1 do 10, naznačen time što maitanzinoid sadrži tiol grupu.
12. Postupak prema patentnom zahtjevu 11, naznačen time što je maitanzinoid DM1.
13. Postupak prema patentnom zahtjevu 11, naznačen time što je maitanzinoid DM4.
14. Postupak prema bilo kojem od patentnih zahtjeva 1-13, naznačen time što je antitijelo kemijski spojeno sa maitanzinoidom preko kemijskih veza koje su izabrane iz grupe koju čine disulfidne veze, veze osjetljive na kiseline, veze osjetljive na svjetlost, veze osjetljive na peptidazu, tioeterske veze i veze osjetljive na esterazu.
15. Postupak prema bilo kojem od patentnih zahtjeva 1 do 14, naznačen time što se prva smjesa podvrgava filtraciji sa tangencijalnim protokom u koraku (b).
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US71085805P | 2005-08-24 | 2005-08-24 | |
US79771306P | 2006-05-04 | 2006-05-04 | |
PCT/US2006/031653 WO2007024536A2 (en) | 2005-08-24 | 2006-08-14 | Process for preparing maytansinoid antibody conjugates |
Publications (1)
Publication Number | Publication Date |
---|---|
HRP20120794T1 true HRP20120794T1 (hr) | 2012-11-30 |
Family
ID=37666423
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
HRP20120794TT HRP20120794T1 (hr) | 2005-08-24 | 2012-10-04 | Postupak za pripremu proäśišä†enih konjugata lijeka |
Country Status (25)
Country | Link |
---|---|
US (6) | US7811572B2 (hr) |
EP (4) | EP2399609B1 (hr) |
JP (3) | JP5350792B2 (hr) |
KR (1) | KR101301011B1 (hr) |
CN (2) | CN102989000B (hr) |
AU (1) | AU2006283726C1 (hr) |
BR (1) | BRPI0615049B1 (hr) |
CA (5) | CA2893252C (hr) |
CR (2) | CR9742A (hr) |
CY (1) | CY1113206T1 (hr) |
DK (1) | DK1928503T3 (hr) |
EA (1) | EA013327B1 (hr) |
EC (1) | ECSP088212A (hr) |
ES (2) | ES2533992T3 (hr) |
HK (2) | HK1120407A1 (hr) |
HR (1) | HRP20120794T1 (hr) |
IL (6) | IL282138B2 (hr) |
MX (1) | MX2008002597A (hr) |
NZ (4) | NZ716641A (hr) |
PL (1) | PL1928503T3 (hr) |
PT (1) | PT1928503E (hr) |
RS (1) | RS52470B (hr) |
SI (1) | SI1928503T1 (hr) |
WO (1) | WO2007024536A2 (hr) |
ZA (1) | ZA200801564B (hr) |
Families Citing this family (96)
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US20100056762A1 (en) | 2001-05-11 | 2010-03-04 | Old Lloyd J | Specific binding proteins and uses thereof |
ES2552281T3 (es) | 2001-05-11 | 2015-11-26 | Ludwig Institute For Cancer Research Ltd. | Proteínas de unión específica y usos de las mismas |
WO2006012527A1 (en) | 2004-07-23 | 2006-02-02 | Endocyte, Inc. | Bivalent linkers and conjugates thereof |
US20110166319A1 (en) * | 2005-02-11 | 2011-07-07 | Immunogen, Inc. | Process for preparing purified drug conjugates |
AU2006283726C1 (en) * | 2005-08-24 | 2015-05-07 | Immunogen, Inc. | Process for preparing maytansinoid antibody conjugates |
US9090693B2 (en) * | 2007-01-25 | 2015-07-28 | Dana-Farber Cancer Institute | Use of anti-EGFR antibodies in treatment of EGFR mutant mediated disease |
EP2481427A1 (en) | 2007-03-14 | 2012-08-01 | Endocyte, Inc. | Folate-Tubulysin conjugates |
MX2009009782A (es) | 2007-03-15 | 2010-09-10 | Ludwig Inst Cancer Res | Metodo de tratamiento que utiliza anticuerpos egfr e inhibidores de src y formulaciones relacionadas. |
RU2523909C2 (ru) | 2007-06-25 | 2014-07-27 | Эндосайт, Инк. | Конъюгаты, содержащие гидрофильные спейсеры линкеров |
US9877965B2 (en) | 2007-06-25 | 2018-01-30 | Endocyte, Inc. | Vitamin receptor drug delivery conjugates for treating inflammation |
WO2009023265A1 (en) | 2007-08-14 | 2009-02-19 | Ludwig Institute For Cancer Research | Monoclonal antibody 175 targeting the egf receptor and derivatives and uses thereof |
US20100092495A1 (en) * | 2008-04-30 | 2010-04-15 | Immunogen Inc. | Potent cell-binding agent drug conjugates |
US8236319B2 (en) | 2008-04-30 | 2012-08-07 | Immunogen, Inc. | Cross-linkers and their uses |
JP5863640B2 (ja) * | 2009-04-29 | 2016-02-16 | バイオ−ラッド ラボラトリーズ インコーポレーティッド | 免疫複合体の精製 |
ES2726945T3 (es) * | 2009-06-03 | 2019-10-10 | Immunogen Inc | Métodos de conjugación |
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