JP2022036932A5 - - Google Patents

Info

Publication number

JP2022036932A5

JP2022036932A5 JP2021171589A JP2021171589A JP2022036932A5 JP 2022036932 A5 JP2022036932 A5 JP 2022036932A5 JP 2021171589 A JP2021171589 A JP 2021171589A JP 2021171589 A JP2021171589 A JP 2021171589A JP 2022036932 A5 JP2022036932 A5 JP 2022036932A5

Authority

JP

Japan

Prior art keywords

liquid composition

composition according

item

seq

sequence

Prior art date

2021-10-20

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.)

Granted

Links

• Espacenet
• Global Dossier
• Discuss

• 239000000203 mixture Substances 0.000 claims description 153
• 239000007788 liquid Substances 0.000 claims description 109
• 229930006000 Sucrose Natural products 0.000 claims description 33
• 239000005720 sucrose Substances 0.000 claims description 33
• 229920001213 Polysorbate 20 Polymers 0.000 claims description 29
• 239000000256 polyoxyethylene sorbitan monolaurate Substances 0.000 claims description 29
• 235000010486 polyoxyethylene sorbitan monolaurate Nutrition 0.000 claims description 29
• 229940068977 polysorbate 20 Drugs 0.000 claims description 29
• 239000000872 buffer Substances 0.000 claims description 28
• 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 description 25
• HEMHJVSKTPXQMS-UHFFFAOYSA-M Sodium hydroxide Chemical compound [OH-].[Na+] HEMHJVSKTPXQMS-UHFFFAOYSA-M 0.000 claims description 24
• KZSNJWFQEVHDMF-UHFFFAOYSA-N Valine Chemical compound CC(C)C(N)C(O)=O KZSNJWFQEVHDMF-UHFFFAOYSA-N 0.000 claims description 24
• 239000004094 surface-active agent Substances 0.000 claims description 24
• 229940074404 sodium succinate Drugs 0.000 claims description 23
• ZDQYSKICYIVCPN-UHFFFAOYSA-L sodium succinate (anhydrous) Chemical group [Na+].[Na+].[O-]C(=O)CCC([O-])=O ZDQYSKICYIVCPN-UHFFFAOYSA-L 0.000 claims description 23
• 239000008362 succinate buffer Substances 0.000 claims description 23
• 208000015914 Non-Hodgkin lymphomas Diseases 0.000 claims description 20
• 238000001990 intravenous administration Methods 0.000 claims description 18
• KZSNJWFQEVHDMF-BYPYZUCNSA-N L-valine Chemical compound CC(C)[C@H](N)C(O)=O KZSNJWFQEVHDMF-BYPYZUCNSA-N 0.000 claims description 12
• KDYFGRWQOYBRFD-UHFFFAOYSA-N Succinic acid Natural products OC(=O)CCC(O)=O KDYFGRWQOYBRFD-UHFFFAOYSA-N 0.000 claims description 12
• 239000004474 valine Substances 0.000 claims description 12
• XLYOFNOQVPJJNP-UHFFFAOYSA-N water Chemical compound O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims description 12
• 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 claims description 11
• 230000002062 proliferating effect Effects 0.000 claims description 11
• 239000008227 sterile water for injection Substances 0.000 claims description 11
• PEDCQBHIVMGVHV-UHFFFAOYSA-N Glycerine Chemical compound OCC(O)CO PEDCQBHIVMGVHV-UHFFFAOYSA-N 0.000 claims description 9
• 210000003719 b-lymphocyte Anatomy 0.000 claims description 8
• KDYFGRWQOYBRFD-NUQCWPJISA-N butanedioic acid Chemical compound O[14C](=O)CC[14C](O)=O KDYFGRWQOYBRFD-NUQCWPJISA-N 0.000 claims description 8
• 125000000185 sucrose group Chemical group 0.000 claims description 8
• FWMNVWWHGCHHJJ-SKKKGAJSSA-N 4-amino-1-[(2r)-6-amino-2-[[(2r)-2-[[(2r)-2-[[(2r)-2-amino-3-phenylpropanoyl]amino]-3-phenylpropanoyl]amino]-4-methylpentanoyl]amino]hexanoyl]piperidine-4-carboxylic acid Chemical compound C([C@H](C(=O)N[C@H](CC(C)C)C(=O)N[C@H](CCCCN)C(=O)N1CCC(N)(CC1)C(O)=O)NC(=O)[C@H](N)CC=1C=CC=CC=1)C1=CC=CC=C1 FWMNVWWHGCHHJJ-SKKKGAJSSA-N 0.000 claims description 7
• 208000031671 Large B-Cell Diffuse Lymphoma Diseases 0.000 claims description 7
• 206010012818 diffuse large B-cell lymphoma Diseases 0.000 claims description 7
• 230000000306 recurrent effect Effects 0.000 claims description 7
• 230000001684 chronic effect Effects 0.000 claims description 6
• 201000003444 follicular lymphoma Diseases 0.000 claims description 6
• 208000010839 B-cell chronic lymphocytic leukemia Diseases 0.000 claims description 4
• 206010025323 Lymphomas Diseases 0.000 claims description 4
• HNDVDQJCIGZPNO-UHFFFAOYSA-N histidine Natural products OC(=O)C(N)CC1=CN=CN1 HNDVDQJCIGZPNO-UHFFFAOYSA-N 0.000 claims description 4
• 125000000487 histidyl group Chemical group [H]N([H])C(C(=O)O*)C([H])([H])C1=C([H])N([H])C([H])=N1 0.000 claims description 4
• 208000032839 leukemia Diseases 0.000 claims description 4
• HEGSGKPQLMEBJL-UHFFFAOYSA-N n-octyl beta-D-glucopyranoside Natural products CCCCCCCCOC1OC(CO)C(O)C(O)C1O HEGSGKPQLMEBJL-UHFFFAOYSA-N 0.000 claims description 4
• HEGSGKPQLMEBJL-RKQHYHRCSA-N octyl beta-D-glucopyranoside Chemical compound CCCCCCCCO[C@@H]1O[C@H](CO)[C@@H](O)[C@H](O)[C@H]1O HEGSGKPQLMEBJL-RKQHYHRCSA-N 0.000 claims description 4
• 239000000244 polyoxyethylene sorbitan monooleate Substances 0.000 claims description 4
• 235000010482 polyoxyethylene sorbitan monooleate Nutrition 0.000 claims description 4
• 229920000053 polysorbate 80 Polymers 0.000 claims description 4
• 229940068968 polysorbate 80 Drugs 0.000 claims description 4
• HDTRYLNUVZCQOY-UHFFFAOYSA-N α-D-glucopyranosyl-α-D-glucopyranoside Natural products OC1C(O)C(O)C(CO)OC1OC1C(O)C(O)C(O)C(CO)O1 HDTRYLNUVZCQOY-UHFFFAOYSA-N 0.000 claims description 3
• FBPFZTCFMRRESA-FSIIMWSLSA-N D-Glucitol Natural products OC[C@H](O)[C@H](O)[C@@H](O)[C@H](O)CO FBPFZTCFMRRESA-FSIIMWSLSA-N 0.000 claims description 3
• FBPFZTCFMRRESA-KVTDHHQDSA-N D-Mannitol Chemical compound OC[C@@H](O)[C@@H](O)[C@H](O)[C@H](O)CO FBPFZTCFMRRESA-KVTDHHQDSA-N 0.000 claims description 3
• FBPFZTCFMRRESA-JGWLITMVSA-N D-glucitol Chemical compound OC[C@H](O)[C@@H](O)[C@H](O)[C@H](O)CO FBPFZTCFMRRESA-JGWLITMVSA-N 0.000 claims description 3
• CTKXFMQHOOWWEB-UHFFFAOYSA-N Ethylene oxide/propylene oxide copolymer Chemical compound CCCOC(C)COCCO CTKXFMQHOOWWEB-UHFFFAOYSA-N 0.000 claims description 3
• 229930195725 Mannitol Natural products 0.000 claims description 3
• HDTRYLNUVZCQOY-WSWWMNSNSA-N Trehalose Natural products O[C@@H]1[C@@H](O)[C@@H](O)[C@@H](CO)O[C@@H]1O[C@@H]1[C@H](O)[C@@H](O)[C@@H](O)[C@@H](CO)O1 HDTRYLNUVZCQOY-WSWWMNSNSA-N 0.000 claims description 3
• HDTRYLNUVZCQOY-LIZSDCNHSA-N alpha,alpha-trehalose Chemical compound O[C@@H]1[C@@H](O)[C@H](O)[C@@H](CO)O[C@@H]1O[C@@H]1[C@H](O)[C@@H](O)[C@H](O)[C@@H](CO)O1 HDTRYLNUVZCQOY-LIZSDCNHSA-N 0.000 claims description 3
• 229940119744 dextran 40 Drugs 0.000 claims description 3
• FZWBNHMXJMCXLU-BLAUPYHCSA-N isomaltotriose Chemical compound O[C@@H]1[C@@H](O)[C@H](O)[C@@H](CO)O[C@@H]1OC[C@@H]1[C@@H](O)[C@H](O)[C@@H](O)[C@@H](OC[C@@H](O)[C@@H](O)[C@H](O)[C@@H](O)C=O)O1 FZWBNHMXJMCXLU-BLAUPYHCSA-N 0.000 claims description 3
• 239000000594 mannitol Substances 0.000 claims description 3
• 235000010355 mannitol Nutrition 0.000 claims description 3
• 229920001993 poloxamer 188 Polymers 0.000 claims description 3
• 229940044519 poloxamer 188 Drugs 0.000 claims description 3
• 239000000600 sorbitol Substances 0.000 claims description 3
• 208000031422 Lymphocytic Chronic B-Cell Leukemia Diseases 0.000 claims description 2
• 208000025205 Mantle-Cell Lymphoma Diseases 0.000 claims description 2
• 206010035226 Plasma cell myeloma Diseases 0.000 claims description 2
• 201000000050 myeloid neoplasm Diseases 0.000 claims description 2
• 229940127121 immunoconjugate Drugs 0.000 claims 11
• 150000001413 amino acids Chemical group 0.000 claims 4
• 208000024893 Acute lymphoblastic leukemia Diseases 0.000 claims 2
• 208000014697 Acute lymphocytic leukaemia Diseases 0.000 claims 2
• 208000006664 Precursor Cell Lymphoblastic Leukemia-Lymphoma Diseases 0.000 claims 2
• 208000035475 disorder Diseases 0.000 claims 2
• 201000009277 hairy cell leukemia Diseases 0.000 claims 2
• 238000010253 intravenous injection Methods 0.000 claims 2
• 239000002736 nonionic surfactant Substances 0.000 claims 2
• 238000007865 diluting Methods 0.000 claims 1
• 239000008194 pharmaceutical composition Substances 0.000 description 92
• 125000003275 alpha amino acid group Chemical group 0.000 description 22
• 239000000243 solution Substances 0.000 description 10
• 238000000034 method Methods 0.000 description 9
• FAPWRFPIFSIZLT-UHFFFAOYSA-M Sodium chloride Chemical compound [Na+].[Cl-] FAPWRFPIFSIZLT-UHFFFAOYSA-M 0.000 description 8
• 238000003998 size exclusion chromatography high performance liquid chromatography Methods 0.000 description 6
• 238000004108 freeze drying Methods 0.000 description 4
• 239000011780 sodium chloride Substances 0.000 description 4
• 238000010790 dilution Methods 0.000 description 3
• 239000012895 dilution Substances 0.000 description 3
• WQZGKKKJIJFFOK-GASJEMHNSA-N Glucose Chemical compound OC[C@H]1OC(O)[C@H](O)[C@@H](O)[C@@H]1O WQZGKKKJIJFFOK-GASJEMHNSA-N 0.000 description 2
• 206010028980 Neoplasm Diseases 0.000 description 2
• 230000002378 acidificating effect Effects 0.000 description 2
• 201000011510 cancer Diseases 0.000 description 2
• 238000000533 capillary isoelectric focusing Methods 0.000 description 2
• 238000003384 imaging method Methods 0.000 description 2
• 239000001384 succinic acid Substances 0.000 description 2
• 239000012190 activator Substances 0.000 description 1
• 230000001154 acute effect Effects 0.000 description 1
• 238000003556 assay Methods 0.000 description 1
• 230000022534 cell killing Effects 0.000 description 1
• 239000003599 detergent Substances 0.000 description 1
• 239000003085 diluting agent Substances 0.000 description 1
• 239000011521 glass Substances 0.000 description 1
• 210000002768 hair cell Anatomy 0.000 description 1
• 230000009545 invasion Effects 0.000 description 1
• 210000002751 lymph Anatomy 0.000 description 1
• 230000001568 sexual effect Effects 0.000 description 1
• KDYFGRWQOYBRFD-UHFFFAOYSA-L succinate(2-) Chemical compound [O-]C(=O)CCC([O-])=O KDYFGRWQOYBRFD-UHFFFAOYSA-L 0.000 description 1