JP2008528612A5 - - Google Patents
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- Publication number
- JP2008528612A5 JP2008528612A5 JP2007553242A JP2007553242A JP2008528612A5 JP 2008528612 A5 JP2008528612 A5 JP 2008528612A5 JP 2007553242 A JP2007553242 A JP 2007553242A JP 2007553242 A JP2007553242 A JP 2007553242A JP 2008528612 A5 JP2008528612 A5 JP 2008528612A5
- Authority
- JP
- Japan
- Prior art keywords
- concentration
- pta
- formulation
- antibody
- atcc deposit
- 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.)
- Granted
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- HNDVDQJCIGZPNO-YFKPBYRVSA-N L-histidine Chemical compound OC(=O)[C@@H](N)CC1=CN=CN1 HNDVDQJCIGZPNO-YFKPBYRVSA-N 0.000 claims 25
- 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 22
- 238000009472 formulation Methods 0.000 claims 17
- 239000000203 mixture Substances 0.000 claims 17
- 229960002885 histidine Drugs 0.000 claims 12
- 235000010355 mannitol Nutrition 0.000 claims 12
- 150000001413 amino acids Chemical group 0.000 claims 10
- 239000000825 pharmaceutical preparation Substances 0.000 claims 8
- 201000010099 disease Diseases 0.000 claims 6
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 claims 6
- 239000000244 polyoxyethylene sorbitan monooleate Substances 0.000 claims 6
- 235000010482 polyoxyethylene sorbitan monooleate Nutrition 0.000 claims 6
- 229920000053 polysorbate 80 Polymers 0.000 claims 6
- 229940068968 polysorbate 80 Drugs 0.000 claims 6
- 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 4
- 239000004480 active ingredient Substances 0.000 claims 4
- 229940127557 pharmaceutical product Drugs 0.000 claims 4
- FFEARJCKVFRZRR-SCSAIBSYSA-N D-methionine Chemical compound CSCC[C@@H](N)C(O)=O FFEARJCKVFRZRR-SCSAIBSYSA-N 0.000 claims 3
- FAPWRFPIFSIZLT-UHFFFAOYSA-M Sodium chloride Chemical compound [Na+].[Cl-] FAPWRFPIFSIZLT-UHFFFAOYSA-M 0.000 claims 3
- 239000011521 glass Substances 0.000 claims 3
- 102000009091 Amyloidogenic Proteins Human genes 0.000 claims 2
- 108010048112 Amyloidogenic Proteins Proteins 0.000 claims 2
- 229930195725 Mannitol Natural products 0.000 claims 2
- 230000003942 amyloidogenic effect Effects 0.000 claims 2
- 239000002552 dosage form Substances 0.000 claims 2
- 238000001914 filtration Methods 0.000 claims 2
- 239000000594 mannitol Substances 0.000 claims 2
- 238000000034 method Methods 0.000 claims 2
- 239000008194 pharmaceutical composition Substances 0.000 claims 2
- 238000002360 preparation method Methods 0.000 claims 2
- FFEARJCKVFRZRR-BYPYZUCNSA-N L-methionine Chemical compound CSCC[C@H](N)C(O)=O FFEARJCKVFRZRR-BYPYZUCNSA-N 0.000 claims 1
- 238000007865 diluting Methods 0.000 claims 1
- 238000004108 freeze drying Methods 0.000 claims 1
- HNDVDQJCIGZPNO-UHFFFAOYSA-N histidine Natural products OC(=O)C(N)CC1=CN=CN1 HNDVDQJCIGZPNO-UHFFFAOYSA-N 0.000 claims 1
- 238000004519 manufacturing process Methods 0.000 claims 1
- 238000002844 melting Methods 0.000 claims 1
- 230000008018 melting Effects 0.000 claims 1
- 229930182817 methionine Natural products 0.000 claims 1
- 229920000136 polysorbate Polymers 0.000 claims 1
- 229950008882 polysorbate Drugs 0.000 claims 1
- 230000002265 prevention Effects 0.000 claims 1
- 238000007789 sealing Methods 0.000 claims 1
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US64863105P | 2005-01-28 | 2005-01-28 | |
| US60/648,631 | 2005-01-28 | ||
| PCT/US2006/002837 WO2006083689A2 (en) | 2005-01-28 | 2006-01-27 | Anti a beta antibody formulation |
Publications (3)
| Publication Number | Publication Date |
|---|---|
| JP2008528612A JP2008528612A (ja) | 2008-07-31 |
| JP2008528612A5 true JP2008528612A5 (https=) | 2009-03-19 |
| JP4977625B2 JP4977625B2 (ja) | 2012-07-18 |
Family
ID=36686080
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2007553242A Expired - Fee Related JP4977625B2 (ja) | 2005-01-28 | 2006-01-27 | 抗ａベータ抗体製剤 |
Country Status (29)
| Country | Link |
|---|---|
| US (2) | US7635473B2 (https=) |
| EP (2) | EP2392353A1 (https=) |
| JP (1) | JP4977625B2 (https=) |
| KR (1) | KR101188060B1 (https=) |
| CN (2) | CN101262884B (https=) |
| AR (1) | AR052198A1 (https=) |
| AU (1) | AU2006211184B8 (https=) |
| BR (1) | BRPI0607039A2 (https=) |
| CA (1) | CA2593122C (https=) |
| DK (1) | DK1853310T3 (https=) |
| DO (1) | DOP2006000021A (https=) |
| EA (2) | EA015147B1 (https=) |
| ES (1) | ES2391407T3 (https=) |
| GT (1) | GT200600031A (https=) |
| IL (1) | IL184599A (https=) |
| JO (1) | JO2740B1 (https=) |
| MX (1) | MX2007009050A (https=) |
| MY (1) | MY177052A (https=) |
| NO (1) | NO20073305L (https=) |
| NZ (1) | NZ556393A (https=) |
| PE (1) | PE20060879A1 (https=) |
| PL (1) | PL1853310T3 (https=) |
| PT (1) | PT1853310E (https=) |
| SI (1) | SI1853310T1 (https=) |
| TW (1) | TWI398263B (https=) |
| UA (1) | UA87549C2 (https=) |
| UY (1) | UY29351A1 (https=) |
| WO (1) | WO2006083689A2 (https=) |
| ZA (1) | ZA200705710B (https=) |
Families Citing this family (110)
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