JP2018505128A5 - - Google Patents
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- Publication number
- JP2018505128A5 JP2018505128A5 JP2017525940A JP2017525940A JP2018505128A5 JP 2018505128 A5 JP2018505128 A5 JP 2018505128A5 JP 2017525940 A JP2017525940 A JP 2017525940A JP 2017525940 A JP2017525940 A JP 2017525940A JP 2018505128 A5 JP2018505128 A5 JP 2018505128A5
- Authority
- JP
- Japan
- Prior art keywords
- buffer
- antibody
- process according
- solution
- piperazine
- Prior art date
- 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.)
- Ceased
Links
- 238000000034 method Methods 0.000 claims description 93
- 238000006243 chemical reaction Methods 0.000 claims description 24
- 239000011230 binding agent Substances 0.000 claims description 22
- 239000000872 buffer Substances 0.000 claims description 19
- 239000000243 solution Substances 0.000 claims description 19
- 230000001588 bifunctional effect Effects 0.000 claims description 18
- 239000003431 cross linking reagent Substances 0.000 claims description 18
- 239000007853 buffer solution Substances 0.000 claims description 17
- 231100000599 cytotoxic agent Toxicity 0.000 claims description 14
- 229940127089 cytotoxic agent Drugs 0.000 claims description 14
- 239000002254 cytotoxic agent Substances 0.000 claims description 14
- 239000000203 mixture Substances 0.000 claims description 14
- OWXMKDGYPWMGEB-UHFFFAOYSA-N HEPPS Chemical compound OCCN1CCN(CCCS(O)(=O)=O)CC1 OWXMKDGYPWMGEB-UHFFFAOYSA-N 0.000 claims description 13
- 239000003960 organic solvent Substances 0.000 claims description 12
- FAPWRFPIFSIZLT-UHFFFAOYSA-M Sodium chloride Chemical compound [Na+].[Cl-] FAPWRFPIFSIZLT-UHFFFAOYSA-M 0.000 claims description 10
- JKMHFZQWWAIEOD-UHFFFAOYSA-N 2-[4-(2-hydroxyethyl)piperazin-1-yl]ethanesulfonic acid Chemical compound OCC[NH+]1CCN(CCS([O-])(=O)=O)CC1 JKMHFZQWWAIEOD-UHFFFAOYSA-N 0.000 claims description 8
- LVQFQZZGTZFUNF-UHFFFAOYSA-N 2-hydroxy-3-[4-(2-hydroxy-3-sulfonatopropyl)piperazine-1,4-diium-1-yl]propane-1-sulfonate Chemical compound OS(=O)(=O)CC(O)CN1CCN(CC(O)CS(O)(=O)=O)CC1 LVQFQZZGTZFUNF-UHFFFAOYSA-N 0.000 claims description 7
- JOCBASBOOFNAJA-UHFFFAOYSA-N N-tris(hydroxymethyl)methyl-2-aminoethanesulfonic acid Chemical compound OCC(CO)(CO)NCCS(O)(=O)=O JOCBASBOOFNAJA-UHFFFAOYSA-N 0.000 claims description 7
- 239000011780 sodium chloride Substances 0.000 claims description 5
- SXGZJKUKBWWHRA-UHFFFAOYSA-N 2-(N-morpholiniumyl)ethanesulfonate Chemical compound [O-]S(=O)(=O)CC[NH+]1CCOCC1 SXGZJKUKBWWHRA-UHFFFAOYSA-N 0.000 claims description 4
- 239000007995 HEPES buffer Substances 0.000 claims description 4
- GIZQLVPDAOBAFN-UHFFFAOYSA-N HEPPSO Chemical group OCCN1CCN(CC(O)CS(O)(=O)=O)CC1 GIZQLVPDAOBAFN-UHFFFAOYSA-N 0.000 claims description 4
- 239000008351 acetate buffer Substances 0.000 claims description 4
- 239000007979 citrate buffer Substances 0.000 claims description 4
- 231100000433 cytotoxic Toxicity 0.000 claims description 4
- 230000001472 cytotoxic effect Effects 0.000 claims description 4
- 239000008363 phosphate buffer Substances 0.000 claims description 4
- YCLWMUYXEGEIGD-UHFFFAOYSA-M sodium;2-hydroxy-3-[4-(2-hydroxyethyl)piperazin-1-yl]propane-1-sulfonate Chemical compound [Na+].OCCN1CCN(CC(O)CS([O-])(=O)=O)CC1 YCLWMUYXEGEIGD-UHFFFAOYSA-M 0.000 claims description 4
- 239000008362 succinate buffer Substances 0.000 claims description 4
- 230000003432 anti-folate effect Effects 0.000 claims description 2
- 229940127074 antifolate Drugs 0.000 claims description 2
- 239000004052 folic acid antagonist Substances 0.000 claims description 2
- 102000006495 integrins Human genes 0.000 claims description 2
- 108010044426 integrins Proteins 0.000 claims description 2
- 238000004519 manufacturing process Methods 0.000 claims description 2
- 102000005962 receptors Human genes 0.000 claims description 2
- 108020003175 receptors Proteins 0.000 claims description 2
- 229960004641 rituximab Drugs 0.000 claims description 2
- 150000003839 salts Chemical class 0.000 claims description 2
- 231100000167 toxic agent Toxicity 0.000 claims description 2
- 239000003440 toxic substance Substances 0.000 claims description 2
- 229960000575 trastuzumab Drugs 0.000 claims description 2
- 239000006172 buffering agent Substances 0.000 claims 1
- 238000013467 fragmentation Methods 0.000 claims 1
- 238000006062 fragmentation reaction Methods 0.000 claims 1
- 238000010791 quenching Methods 0.000 claims 1
- 230000000171 quenching effect Effects 0.000 claims 1
- QTBSBXVTEAMEQO-UHFFFAOYSA-N Acetic acid Chemical compound CC(O)=O QTBSBXVTEAMEQO-UHFFFAOYSA-N 0.000 description 3
- KCXVZYZYPLLWCC-UHFFFAOYSA-N EDTA Chemical compound OC(=O)CN(CC(O)=O)CCN(CC(O)=O)CC(O)=O KCXVZYZYPLLWCC-UHFFFAOYSA-N 0.000 description 3
- 229920001213 Polysorbate 20 Polymers 0.000 description 3
- 235000010486 polyoxyethylene sorbitan monolaurate Nutrition 0.000 description 3
- 239000000256 polyoxyethylene sorbitan monolaurate Substances 0.000 description 3
- FUHCFUVCWLZEDQ-UHFFFAOYSA-N 1-(2,5-dioxopyrrolidin-1-yl)oxy-1-oxo-4-(pyridin-2-yldisulfanyl)butane-2-sulfonic acid Chemical compound O=C1CCC(=O)N1OC(=O)C(S(=O)(=O)O)CCSSC1=CC=CC=N1 FUHCFUVCWLZEDQ-UHFFFAOYSA-N 0.000 description 2
- QTBSBXVTEAMEQO-UHFFFAOYSA-M Acetate Chemical compound CC([O-])=O QTBSBXVTEAMEQO-UHFFFAOYSA-M 0.000 description 2
- 229930006000 Sucrose Natural products 0.000 description 2
- 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 description 2
- 238000005377 adsorption chromatography Methods 0.000 description 2
- 125000003275 alpha amino acid group Chemical group 0.000 description 2
- 230000021615 conjugation Effects 0.000 description 2
- 238000009295 crossflow filtration Methods 0.000 description 2
- 229940068977 polysorbate 20 Drugs 0.000 description 2
- 239000005720 sucrose Substances 0.000 description 2
- LSNNMFCWUKXFEE-UHFFFAOYSA-M Bisulfite Chemical compound OS([O-])=O LSNNMFCWUKXFEE-UHFFFAOYSA-M 0.000 description 1
- KFZMGEQAYNKOFK-UHFFFAOYSA-N Isopropanol Chemical compound CC(C)O KFZMGEQAYNKOFK-UHFFFAOYSA-N 0.000 description 1
- 239000007983 Tris buffer Substances 0.000 description 1
- 150000008064 anhydrides Chemical class 0.000 description 1
- 238000000502 dialysis Methods 0.000 description 1
- 238000001914 filtration Methods 0.000 description 1
- 239000012537 formulation buffer Substances 0.000 description 1
- 125000004029 hydroxymethyl group Chemical group [H]OC([H])([H])* 0.000 description 1
- 238000011065 in-situ storage Methods 0.000 description 1
- 125000002496 methyl group Chemical group [H]C([H])([H])* 0.000 description 1
- 238000001556 precipitation Methods 0.000 description 1
- 239000011535 reaction buffer Substances 0.000 description 1
- 238000001179 sorption measurement Methods 0.000 description 1
- 239000011550 stock solution Substances 0.000 description 1
- 230000008685 targeting Effects 0.000 description 1
- 229960003080 taurine Drugs 0.000 description 1
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US201462081914P | 2014-11-19 | 2014-11-19 | |
| US62/081,914 | 2014-11-19 | ||
| PCT/US2015/061310 WO2016081584A1 (en) | 2014-11-19 | 2015-11-18 | Process for preparing cell-binding agent-cytotoxic agent conjugates |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| JP2018505128A JP2018505128A (ja) | 2018-02-22 |
| JP2018505128A5 true JP2018505128A5 (https=) | 2018-12-27 |
Family
ID=54754814
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2017525940A Ceased JP2018505128A (ja) | 2014-11-19 | 2015-11-18 | 細胞結合剤−細胞毒性剤コンジュゲートを調製するためのプロセス |
Country Status (12)
| Country | Link |
|---|---|
| US (2) | US10413615B2 (https=) |
| EP (1) | EP3220959A1 (https=) |
| JP (1) | JP2018505128A (https=) |
| KR (1) | KR20170088905A (https=) |
| CN (1) | CN107592813A (https=) |
| AU (1) | AU2015349985A1 (https=) |
| CA (1) | CA2966932A1 (https=) |
| IL (1) | IL251900B (https=) |
| MA (1) | MA40934A (https=) |
| RU (1) | RU2711930C2 (https=) |
| SG (1) | SG11201703599VA (https=) |
| WO (1) | WO2016081584A1 (https=) |
Families Citing this family (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| TW202116356A (zh) | 2019-07-10 | 2021-05-01 | 美商斯布雷克薩三號公司 | 作為治療劑之微管靶向藥劑之肽結合物 |
| CN114341162B (zh) | 2019-07-10 | 2025-10-17 | 赛博克萨2公司 | 作为治疗剂的细胞毒素的肽缀合物 |
Family Cites Families (55)
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|---|---|---|---|---|
| US4307016A (en) | 1978-03-24 | 1981-12-22 | Takeda Chemical Industries, Ltd. | Demethyl maytansinoids |
| US4256746A (en) | 1978-11-14 | 1981-03-17 | Takeda Chemical Industries | Dechloromaytansinoids, their pharmaceutical compositions and method of use |
| JPS55102583A (en) | 1979-01-31 | 1980-08-05 | Takeda Chem Ind Ltd | 20-acyloxy-20-demethylmaytansinoid compound |
| JPS55162791A (en) | 1979-06-05 | 1980-12-18 | Takeda Chem Ind Ltd | Antibiotic c-15003pnd and its preparation |
| JPS5645483A (en) | 1979-09-19 | 1981-04-25 | Takeda Chem Ind Ltd | C-15003phm and its preparation |
| JPS5645485A (en) | 1979-09-21 | 1981-04-25 | Takeda Chem Ind Ltd | Production of c-15003pnd |
| EP0028683A1 (en) | 1979-09-21 | 1981-05-20 | Takeda Chemical Industries, Ltd. | Antibiotic C-15003 PHO and production thereof |
| WO1982001188A1 (en) | 1980-10-08 | 1982-04-15 | Takeda Chemical Industries Ltd | 4,5-deoxymaytansinoide compounds and process for preparing same |
| US4450254A (en) | 1980-11-03 | 1984-05-22 | Standard Oil Company | Impact improvement of high nitrile resins |
| US4313946A (en) | 1981-01-27 | 1982-02-02 | The United States Of America As Represented By The Secretary Of Agriculture | Chemotherapeutically active maytansinoids from Trewia nudiflora |
| US4315929A (en) | 1981-01-27 | 1982-02-16 | The United States Of America As Represented By The Secretary Of Agriculture | Method of controlling the European corn borer with trewiasine |
| JPS57192389A (en) | 1981-05-20 | 1982-11-26 | Takeda Chem Ind Ltd | Novel maytansinoid |
| GB8607679D0 (en) | 1986-03-27 | 1986-04-30 | Winter G P | Recombinant dna product |
| US5225539A (en) | 1986-03-27 | 1993-07-06 | Medical Research Council | Recombinant altered antibodies and methods of making altered antibodies |
| US5530101A (en) | 1988-12-28 | 1996-06-25 | Protein Design Labs, Inc. | Humanized immunoglobulins |
| GB9015198D0 (en) | 1990-07-10 | 1990-08-29 | Brien Caroline J O | Binding substance |
| US5545806A (en) | 1990-08-29 | 1996-08-13 | Genpharm International, Inc. | Ransgenic non-human animals for producing heterologous antibodies |
| ATE300615T1 (de) | 1990-08-29 | 2005-08-15 | Genpharm Int | Transgene mäuse fähig zur produktion heterologer antikörper |
| SE9102074D0 (sv) | 1991-07-03 | 1991-07-03 | Kabi Pharmacia Ab | Tomour antigen specific antibody |
| ES2341666T3 (es) | 1991-12-02 | 2010-06-24 | Medimmune Limited | Produccion de autoanticuerpos de repertorios de segmentos de anticue rpos expresados en la superficie de fagos. |
| ES2149768T3 (es) | 1992-03-25 | 2000-11-16 | Immunogen Inc | Conjugados de agentes enlazantes de celulas derivados de cc-1065. |
| US5639641A (en) | 1992-09-09 | 1997-06-17 | Immunogen Inc. | Resurfacing of rodent antibodies |
| IL111748A0 (en) | 1993-12-03 | 1995-01-24 | Zeneca Ltd | Proteins |
| US6265150B1 (en) | 1995-06-07 | 2001-07-24 | Becton Dickinson & Company | Phage antibodies |
| US5714352A (en) | 1996-03-20 | 1998-02-03 | Xenotech Incorporated | Directed switch-mediated DNA recombination |
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| CA2297070A1 (en) | 1997-08-01 | 1999-02-11 | Morphosys Ag | Novel method and phage for the identification of nucleic acid sequences encoding members of a multimeric (poly)peptide complex |
| TW593241B (en) | 1999-04-20 | 2004-06-21 | Hoffmann La Roche | Carbamic acid derivatives |
| WO2001058479A1 (en) | 2000-02-08 | 2001-08-16 | The Penn State Research Foundation | Immunotherapy using interleukin 13 receptor subunit alpha 2 |
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| BRPI1010620B8 (pt) * | 2009-06-03 | 2021-05-25 | Immunogen Inc | métodos de conjugação |
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| AR078471A1 (es) | 2009-10-02 | 2011-11-09 | Sanofi Aventis | COMPUESTOS MAITANSINOIDES Y EL USO DE ESTOS PARA PREPARAR CONJUGADOS CON UN ANTICUERPO LOS CUALES SE UTILIZAN COMO AGENTES ANTICANCERIGENOS Y EL PROCEDIMIENTO DE PREPARACIoN DE ESTOS CONJUGADOS |
| CN103037900B (zh) | 2010-02-24 | 2016-04-06 | 伊缪诺金公司 | 叶酸受体1抗体与免疫缀合物以及其用途 |
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| JP6049642B2 (ja) * | 2011-02-15 | 2016-12-21 | イミュノジェン・インコーポレーテッド | 複合体の調製方法 |
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| JP6494533B2 (ja) * | 2013-02-28 | 2019-04-03 | イミュノジェン・インコーポレーテッド | 細胞結合剤及び細胞毒性剤としてのマイタンシノイドを含む複合体 |
| US9498532B2 (en) * | 2013-03-13 | 2016-11-22 | Novartis Ag | Antibody drug conjugates |
| SG11201806478PA (en) * | 2016-02-05 | 2018-08-30 | Immunogen Inc | Efficient process for preparing cell-binding agent-cytotoxic agent conjugates |
| MA51629A (fr) * | 2018-01-12 | 2020-11-18 | Immunogen Inc | Procédés de production, purification et formulation de conjugués anticorps-médicaments |
-
2015
- 2015-11-18 EP EP15802310.1A patent/EP3220959A1/en not_active Withdrawn
- 2015-11-18 CN CN201580060700.2A patent/CN107592813A/zh active Pending
- 2015-11-18 MA MA040934A patent/MA40934A/fr unknown
- 2015-11-18 AU AU2015349985A patent/AU2015349985A1/en not_active Abandoned
- 2015-11-18 US US15/527,525 patent/US10413615B2/en not_active Expired - Fee Related
- 2015-11-18 WO PCT/US2015/061310 patent/WO2016081584A1/en not_active Ceased
- 2015-11-18 CA CA2966932A patent/CA2966932A1/en not_active Abandoned
- 2015-11-18 KR KR1020177016749A patent/KR20170088905A/ko not_active Withdrawn
- 2015-11-18 JP JP2017525940A patent/JP2018505128A/ja not_active Ceased
- 2015-11-18 RU RU2017115812A patent/RU2711930C2/ru active
- 2015-11-18 SG SG11201703599VA patent/SG11201703599VA/en unknown
-
2017
- 2017-04-25 IL IL251900A patent/IL251900B/en not_active IP Right Cessation
-
2019
- 2019-08-07 US US16/534,521 patent/US20200101168A1/en not_active Abandoned
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