JP2012507553A5 - - Google Patents

Info

Publication number

JP2012507553A5

JP2012507553A5 JP2011534779A JP2011534779A JP2012507553A5 JP 2012507553 A5 JP2012507553 A5 JP 2012507553A5 JP 2011534779 A JP2011534779 A JP 2011534779A JP 2011534779 A JP2011534779 A JP 2011534779A JP 2012507553 A5 JP2012507553 A5 JP 2012507553A5

Authority

JP

Japan

Prior art keywords

formulation

tnf

concentration

binding nanobody

molecule

Prior art date

2009-10-29

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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• 239000000203 mixture Substances 0.000 claims 39
• 238000009472 formulation Methods 0.000 claims 36
• 102100040247 Tumor necrosis factor Human genes 0.000 claims 25
• 230000027455 binding Effects 0.000 claims 20
• 238000000034 method Methods 0.000 claims 11
• 239000000872 buffer Substances 0.000 claims 9
• 238000003860 storage Methods 0.000 claims 7
• 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 6
• 229930006000 Sucrose Natural products 0.000 claims 6
• 125000003275 alpha amino acid group Chemical group 0.000 claims 6
• 238000002360 preparation method Methods 0.000 claims 6
• 239000005720 sucrose Substances 0.000 claims 6
• 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 claims 5
• HNDVDQJCIGZPNO-UHFFFAOYSA-N histidine Natural products OC(=O)C(N)CC1=CN=CN1 HNDVDQJCIGZPNO-UHFFFAOYSA-N 0.000 claims 5
• 239000000244 polyoxyethylene sorbitan monooleate Substances 0.000 claims 5
• 235000010482 polyoxyethylene sorbitan monooleate Nutrition 0.000 claims 5
• 229920000053 polysorbate 80 Polymers 0.000 claims 5
• 229940068968 polysorbate 80 Drugs 0.000 claims 5
• 102000008100 Human Serum Albumin Human genes 0.000 claims 4
• 108091006905 Human Serum Albumin Proteins 0.000 claims 4
• 150000001413 amino acids Chemical class 0.000 claims 4
• 208000035475 disorder Diseases 0.000 claims 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 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 3
• 239000007983 Tris buffer Substances 0.000 claims 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 3
• 239000008194 pharmaceutical composition Substances 0.000 claims 3
• 239000004094 surface-active agent Substances 0.000 claims 3
• LENZDBCJOHFCAS-UHFFFAOYSA-N tris Chemical compound OCC(N)(CO)CO LENZDBCJOHFCAS-UHFFFAOYSA-N 0.000 claims 3
• 206010002556 Ankylosing Spondylitis Diseases 0.000 claims 2
• 229920000089 Cyclic olefin copolymer Polymers 0.000 claims 2
• 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 2
• 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 2
• 108060008682 Tumor Necrosis Factor Proteins 0.000 claims 2
• 102000000852 Tumor Necrosis Factor-alpha Human genes 0.000 claims 2
• 230000002378 acidificating effect Effects 0.000 claims 2
• 238000002347 injection Methods 0.000 claims 2
• 239000007924 injection Substances 0.000 claims 2
• 239000007788 liquid Substances 0.000 claims 2
• 125000002924 primary amino group Chemical group [H]N([H])* 0.000 claims 2
• 108090000765 processed proteins & peptides Proteins 0.000 claims 2
• 206010039073 rheumatoid arthritis Diseases 0.000 claims 2
• 239000000600 sorbitol Substances 0.000 claims 2
• 238000006467 substitution reaction Methods 0.000 claims 2
• 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 1
• 208000023275 Autoimmune disease Diseases 0.000 claims 1
• 206010009900 Colitis ulcerative Diseases 0.000 claims 1
• 208000011231 Crohn disease Diseases 0.000 claims 1
• CTKXFMQHOOWWEB-UHFFFAOYSA-N Ethylene oxide/propylene oxide copolymer Chemical compound CCCOC(C)COCCO CTKXFMQHOOWWEB-UHFFFAOYSA-N 0.000 claims 1
• 206010061218 Inflammation Diseases 0.000 claims 1
• 208000003456 Juvenile Arthritis Diseases 0.000 claims 1
• 206010059176 Juvenile idiopathic arthritis Diseases 0.000 claims 1
• 201000004681 Psoriasis Diseases 0.000 claims 1
• 201000001263 Psoriatic Arthritis Diseases 0.000 claims 1
• 208000036824 Psoriatic arthropathy Diseases 0.000 claims 1
• 201000006704 Ulcerative Colitis Diseases 0.000 claims 1
• 239000004480 active ingredient Substances 0.000 claims 1
• 230000002917 arthritic effect Effects 0.000 claims 1
• 238000004113 cell culture Methods 0.000 claims 1
• 238000011097 chromatography purification Methods 0.000 claims 1
• 238000004891 communication Methods 0.000 claims 1
• 238000011026 diafiltration Methods 0.000 claims 1
• 239000003085 diluting agent Substances 0.000 claims 1
• 201000010099 disease Diseases 0.000 claims 1
• 229940126534 drug product Drugs 0.000 claims 1
• 230000008014 freezing Effects 0.000 claims 1
• 238000007710 freezing Methods 0.000 claims 1
• 230000004927 fusion Effects 0.000 claims 1
• 239000011521 glass Substances 0.000 claims 1
• 208000027866 inflammatory disease Diseases 0.000 claims 1
• 230000002757 inflammatory effect Effects 0.000 claims 1
• 230000004054 inflammatory process Effects 0.000 claims 1
• 201000002215 juvenile rheumatoid arthritis Diseases 0.000 claims 1
• 238000002372 labelling Methods 0.000 claims 1
• 238000004519 manufacturing process Methods 0.000 claims 1
• 239000000463 material Substances 0.000 claims 1
• 238000012544 monitoring process Methods 0.000 claims 1
• 201000006417 multiple sclerosis Diseases 0.000 claims 1
• 238000004806 packaging method and process Methods 0.000 claims 1
• 238000002823 phage display Methods 0.000 claims 1
• 239000000825 pharmaceutical preparation Substances 0.000 claims 1
• 229920003023 plastic Polymers 0.000 claims 1
• 229920001993 poloxamer 188 Polymers 0.000 claims 1
• 229940044519 poloxamer 188 Drugs 0.000 claims 1
• 208000019764 polyarticular juvenile idiopathic arthritis Diseases 0.000 claims 1
• 229920001184 polypeptide Polymers 0.000 claims 1
• 229940071643 prefilled syringe Drugs 0.000 claims 1
• 102000004196 processed proteins & peptides Human genes 0.000 claims 1
• 102000004169 proteins and genes Human genes 0.000 claims 1
• 108090000623 proteins and genes Proteins 0.000 claims 1
• 230000001568 sexual effect Effects 0.000 claims 1
• 208000024891 symptom Diseases 0.000 claims 1
• 238000000108 ultra-filtration Methods 0.000 claims 1