JP2010511665A5 - - Google Patents

Info

Publication number

JP2010511665A5

JP2010511665A5 JP2009539730A JP2009539730A JP2010511665A5 JP 2010511665 A5 JP2010511665 A5 JP 2010511665A5 JP 2009539730 A JP2009539730 A JP 2009539730A JP 2009539730 A JP2009539730 A JP 2009539730A JP 2010511665 A5 JP2010511665 A5 JP 2010511665A5

Authority

JP

Japan

Prior art keywords

formulation

rabies virus

antibody

temperature

chain seq

Prior art date

2007-12-04

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

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• 238000009472 formulation Methods 0.000 claims description 28
• 239000000203 mixture Substances 0.000 claims description 28
• 238000002360 preparation method Methods 0.000 claims description 7
• 239000007951 isotonicity adjuster Substances 0.000 claims description 5
• FAPWRFPIFSIZLT-UHFFFAOYSA-M Sodium chloride Chemical group [Na+].[Cl-] FAPWRFPIFSIZLT-UHFFFAOYSA-M 0.000 claims description 4
• 238000011993 High Performance Size Exclusion Chromatography Methods 0.000 claims description 3
• 239000011780 sodium chloride Substances 0.000 claims description 2
• 206010037742 Rabies Diseases 0.000 claims 7
• 241000711798 Rabies lyssavirus Species 0.000 claims 5
• 241000700605 Viruses Species 0.000 claims 5
• 238000000034 method Methods 0.000 claims 5
• 239000008194 pharmaceutical composition Substances 0.000 claims 5
• 239000007979 citrate buffer Substances 0.000 claims 4
• 230000003472 neutralizing effect Effects 0.000 claims 4
• 239000004094 surface-active agent Substances 0.000 claims 4
• 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 3
• 239000002552 dosage form Substances 0.000 claims 2
• 235000010482 polyoxyethylene sorbitan monooleate Nutrition 0.000 claims 2
• 239000000244 polyoxyethylene sorbitan monooleate Substances 0.000 claims 2
• 229920000053 polysorbate 80 Polymers 0.000 claims 2
• 229940068968 polysorbate 80 Drugs 0.000 claims 2
• 230000010530 Virus Neutralization Effects 0.000 claims 1
• 230000015572 biosynthetic process Effects 0.000 claims 1
• 239000006227 byproduct Substances 0.000 claims 1
• 239000002158 endotoxin Substances 0.000 claims 1
• 239000000178 monomer Substances 0.000 claims 1
• 229920000136 polysorbate Polymers 0.000 claims 1
• 229950008882 polysorbate Drugs 0.000 claims 1
• 238000011321 prophylaxis Methods 0.000 claims 1
• 238000011282 treatment Methods 0.000 claims 1
• 239000012929 tonicity agent Substances 0.000 description 3
• 239000007857 degradation product Substances 0.000 description 2
• 102000004169 proteins and genes Human genes 0.000 description 2
• 108090000623 proteins and genes Proteins 0.000 description 2
• 102000001708 Protein Isoforms Human genes 0.000 description 1
• 108010029485 Protein Isoforms Proteins 0.000 description 1
• 238000004220 aggregation Methods 0.000 description 1
• 230000002776 aggregation Effects 0.000 description 1
• SQVRNKJHWKZAKO-UHFFFAOYSA-N beta-N-Acetyl-D-neuraminic acid Natural products CC(=O)NC1C(O)CC(O)(C(O)=O)OC1C(O)C(O)CO SQVRNKJHWKZAKO-UHFFFAOYSA-N 0.000 description 1
• 239000008280 blood Substances 0.000 description 1
• 210000004369 blood Anatomy 0.000 description 1
• 239000003795 chemical substances by application Substances 0.000 description 1
• 239000012535 impurity Substances 0.000 description 1
• 238000012423 maintenance Methods 0.000 description 1
• 230000014759 maintenance of location Effects 0.000 description 1
• 239000011859 microparticle Substances 0.000 description 1
• 230000003204 osmotic effect Effects 0.000 description 1
• 230000017854 proteolysis Effects 0.000 description 1
• 150000003839 salts Chemical class 0.000 description 1
• SQVRNKJHWKZAKO-OQPLDHBCSA-N sialic acid Chemical compound CC(=O)N[C@@H]1[C@@H](O)C[C@@](O)(C(O)=O)OC1[C@H](O)[C@H](O)CO SQVRNKJHWKZAKO-OQPLDHBCSA-N 0.000 description 1
• 238000002415 sodium dodecyl sulfate polyacrylamide gel electrophoresis Methods 0.000 description 1
• -1 sugar Chemical class 0.000 description 1
• 238000011179 visual inspection Methods 0.000 description 1