JP2016534052A5 - - Google Patents

Info

Publication number

JP2016534052A5

JP2016534052A5 JP2016522950A JP2016522950A JP2016534052A5 JP 2016534052 A5 JP2016534052 A5 JP 2016534052A5 JP 2016522950 A JP2016522950 A JP 2016522950A JP 2016522950 A JP2016522950 A JP 2016522950A JP 2016534052 A5 JP2016534052 A5 JP 2016534052A5

Authority

JP

Japan

Prior art keywords

antibody

concentration

seq

present

amino acid

Prior art date

2014-07-03

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
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• 125000003275 alpha amino acid group Chemical group 0.000 claims 11
• 229920001213 Polysorbate 20 Polymers 0.000 claims 8
• 239000000256 polyoxyethylene sorbitan monolaurate Substances 0.000 claims 8
• 235000010486 polyoxyethylene sorbitan monolaurate Nutrition 0.000 claims 8
• 229940068977 polysorbate 20 Drugs 0.000 claims 8
• 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 6
• 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 6
• 239000000203 mixture Substances 0.000 claims 6
• 239000007790 solid phase Substances 0.000 claims 6
• 229940074410 trehalose Drugs 0.000 claims 6
• 238000009472 formulation Methods 0.000 claims 5
• 238000002360 preparation method Methods 0.000 claims 5
• YASYEJJMZJALEJ-UHFFFAOYSA-N Citric acid monohydrate Chemical compound O.OC(=O)CC(O)(C(O)=O)CC(O)=O YASYEJJMZJALEJ-UHFFFAOYSA-N 0.000 claims 4
• KDXKERNSBIXSRK-UHFFFAOYSA-N Lysine Natural products NCCCCC(N)C(O)=O KDXKERNSBIXSRK-UHFFFAOYSA-N 0.000 claims 4
• 239000004472 Lysine Substances 0.000 claims 4
• 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 4
• 210000004899 c-terminal region Anatomy 0.000 claims 4
• 229960002303 citric acid monohydrate Drugs 0.000 claims 4
• 125000003588 lysine group Chemical group [H]N([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])(N([H])[H])C(*)=O 0.000 claims 4
• XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims 4
• 239000007979 citrate buffer Substances 0.000 claims 3
• 239000012535 impurity Substances 0.000 claims 3
• 102000004169 proteins and genes Human genes 0.000 claims 3
• 108090000623 proteins and genes Proteins 0.000 claims 3
• 238000003860 storage Methods 0.000 claims 3
• DPVHGFAJLZWDOC-PVXXTIHASA-N (2r,3s,4s,5r,6r)-2-(hydroxymethyl)-6-[(2r,3r,4s,5s,6r)-3,4,5-trihydroxy-6-(hydroxymethyl)oxan-2-yl]oxyoxane-3,4,5-triol;dihydrate Chemical compound O.O.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 DPVHGFAJLZWDOC-PVXXTIHASA-N 0.000 claims 2
• NFGXHKASABOEEW-UHFFFAOYSA-N 1-methylethyl 11-methoxy-3,7,11-trimethyl-2,4-dodecadienoate Chemical compound COC(C)(C)CCCC(C)CC=CC(C)=CC(=O)OC(C)C NFGXHKASABOEEW-UHFFFAOYSA-N 0.000 claims 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 claims 2
• 229930006000 Sucrose Natural products 0.000 claims 2
• 239000000427 antigen Substances 0.000 claims 2
• 102000036639 antigens Human genes 0.000 claims 2
• 108091007433 antigens Proteins 0.000 claims 2
• 238000004587 chromatography analysis Methods 0.000 claims 2
• 239000003814 drug Substances 0.000 claims 2
• 239000012634 fragment Substances 0.000 claims 2
• 239000004615 ingredient Substances 0.000 claims 2
• 238000002347 injection Methods 0.000 claims 2
• 239000007924 injection Substances 0.000 claims 2
• 229920005862 polyol Polymers 0.000 claims 2
• 150000003077 polyols Chemical class 0.000 claims 2
• NLJMYIDDQXHKNR-UHFFFAOYSA-K sodium citrate Chemical compound O.O.[Na+].[Na+].[Na+].[O-]C(=O)CC(O)(CC([O-])=O)C([O-])=O NLJMYIDDQXHKNR-UHFFFAOYSA-K 0.000 claims 2
• 229960000999 sodium citrate dihydrate Drugs 0.000 claims 2
• 239000005720 sucrose Substances 0.000 claims 2
• 235000000346 sugar Nutrition 0.000 claims 2
• -1 trehalose anhydride Chemical class 0.000 claims 2
• 229940074409 trehalose dihydrate Drugs 0.000 claims 2
• HRXKRNGNAMMEHJ-UHFFFAOYSA-K trisodium citrate Chemical compound [Na+].[Na+].[Na+].[O-]C(=O)CC(O)(CC([O-])=O)C([O-])=O HRXKRNGNAMMEHJ-UHFFFAOYSA-K 0.000 claims 2
• KRKNYBCHXYNGOX-UHFFFAOYSA-K Citrate Chemical compound [O-]C(=O)CC(O)(CC([O-])=O)C([O-])=O KRKNYBCHXYNGOX-UHFFFAOYSA-K 0.000 claims 1
• 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 1
• 238000011993 High Performance Size Exclusion Chromatography Methods 0.000 claims 1
• 229930195725 Mannitol Natural products 0.000 claims 1
• 102000019355 Synuclein Human genes 0.000 claims 1
• 108050006783 Synuclein Proteins 0.000 claims 1
• 241000700605 Viruses Species 0.000 claims 1
• 150000001413 amino acids Chemical class 0.000 claims 1
• 238000005349 anion exchange Methods 0.000 claims 1
• 239000007864 aqueous solution Substances 0.000 claims 1
• 238000005341 cation exchange Methods 0.000 claims 1
• 239000003795 chemical substances by application Substances 0.000 claims 1
• 210000004978 chinese hamster ovary cell Anatomy 0.000 claims 1
• 201000010099 disease Diseases 0.000 claims 1
• 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 claims 1
• 238000002270 exclusion chromatography Methods 0.000 claims 1
• 238000001914 filtration Methods 0.000 claims 1
• 230000002779 inactivation Effects 0.000 claims 1
• 239000012931 lyophilized formulation Substances 0.000 claims 1
• 239000000594 mannitol Substances 0.000 claims 1
• 235000010355 mannitol Nutrition 0.000 claims 1
• 238000004519 manufacturing process Methods 0.000 claims 1
• 238000000034 method Methods 0.000 claims 1
• 230000003204 osmotic effect Effects 0.000 claims 1
• 239000008194 pharmaceutical composition Substances 0.000 claims 1
• 239000000843 powder Substances 0.000 claims 1
• 239000008223 sterile water Substances 0.000 claims 1
• 239000008362 succinate buffer Substances 0.000 claims 1
• 150000008163 sugars Chemical class 0.000 claims 1
• 230000001225 therapeutic effect Effects 0.000 claims 1