JP2008528612A5 - - Google Patents
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- 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
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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
- 102000004965 antibodies Human genes 0.000 claims 21
- 108090001123 antibodies Proteins 0.000 claims 21
- 239000000203 mixture Substances 0.000 claims 18
- 238000009472 formulation Methods 0.000 claims 17
- FBPFZTCFMRRESA-KAZBKCHUSA-N D-Mannitol Natural products OC[C@@H](O)[C@H](O)[C@H](O)[C@H](O)CO FBPFZTCFMRRESA-KAZBKCHUSA-N 0.000 claims 12
- 229960002885 Histidine Drugs 0.000 claims 12
- FBPFZTCFMRRESA-KVTDHHQDSA-N Mannitol Chemical compound OC[C@@H](O)[C@@H](O)[C@H](O)[C@H](O)CO FBPFZTCFMRRESA-KVTDHHQDSA-N 0.000 claims 12
- 235000010355 mannitol Nutrition 0.000 claims 12
- 108010045030 monoclonal antibodies Proteins 0.000 claims 11
- 102000005614 monoclonal antibodies Human genes 0.000 claims 11
- 150000001413 amino acids Chemical group 0.000 claims 10
- 239000000825 pharmaceutical preparation Substances 0.000 claims 8
- 229940068968 Polysorbate 80 Drugs 0.000 claims 6
- 201000010099 disease 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
- 239000004480 active ingredient Substances 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
- 239000011521 glass Substances 0.000 claims 3
- FAPWRFPIFSIZLT-UHFFFAOYSA-M sodium chloride Chemical compound [Na+].[Cl-] FAPWRFPIFSIZLT-UHFFFAOYSA-M 0.000 claims 3
- 239000011780 sodium chloride Substances 0.000 claims 3
- 108010037532 3D6 antibody Proteins 0.000 claims 2
- FFEARJCKVFRZRR-BYPYZUCNSA-N L-methionine Chemical compound CSCC[C@H](N)C(O)=O FFEARJCKVFRZRR-BYPYZUCNSA-N 0.000 claims 2
- 230000003942 amyloidogenic 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
- 239000008194 pharmaceutical composition Substances 0.000 claims 2
- 229920000406 phosphotungstic acid polymer Polymers 0.000 claims 2
- 238000002360 preparation method Methods 0.000 claims 2
- 229950008882 Polysorbate Drugs 0.000 claims 1
- 238000007865 diluting Methods 0.000 claims 1
- 230000002708 enhancing Effects 0.000 claims 1
- 238000004108 freeze drying Methods 0.000 claims 1
- 238000004519 manufacturing process Methods 0.000 claims 1
- 238000002844 melting Methods 0.000 claims 1
- 238000000034 method Methods 0.000 claims 1
- 229920000136 polysorbate Polymers 0.000 claims 1
- 230000002265 prevention Effects 0.000 claims 1
- 238000007789 sealing Methods 0.000 claims 1
Claims (15)
- (a)濃度約1mg/ml〜約100mg/mlのモノクローナル抗体3D6(ATCC寄託番号PTA−5130)のヒト化抗体;
(b)濃度約0.1mM〜約25mMのL−ヒスチジン;および
(c)約1重量/容量%〜約10重量/容量%のD−マンニトール
を含み、かつ、約5.5〜6.5のpHを有する、配合物。 - (a)濃度約20mg/mlのモノクローナル抗体3D6(ATCC寄託番号PTA−5130)のヒト化抗体であって、配列番号1のアミノ酸配列を含む軽鎖および配列番号2のアミノ酸配列を含む重鎖を含んでなる抗体;
(b)濃度約10mMのL−ヒスチジン;
(c)約4重量/容量%の量のD−マンニトール;
(d)濃度10mMのメチオニン;および
(e)0.005重量/容量%の量のポリソルベート80
を含んでなり、かつ、6.0のpHを有する、請求項1記載の配合物。 - (a)濃度30mg/ml〜100mg/mlのモノクローナル抗体3D6(ATCC寄託番号PTA−5130)のヒト化抗体;
(b)濃度0.1mM〜25mMのL−ヒスチジン;および
(c)0.001重量/容量%〜0.01重量/容量%のポリソルベート80を含んでなり、かつ、約5.5〜6.5のpHを有する、配合物。 - (a)濃度50mg/mlのモノクローナル抗体3D6(ATCC寄託番号PTA−5130)のヒト化抗体であって、配列番号1のアミノ酸配列を含む軽鎖および配列番号2のアミノ酸配列を含む重鎖を含んでなる抗体;
(b)濃度10mMのL−ヒスチジン;
(c)0.005重量/容量%のポリソルベート80;および
(d)濃度10mMのメチオニンを含んでなり、かつ、6.0のpHを有する、請求項3記載の配合物。 - (a)10mg〜250mgのモノクローナル抗体3D6(ATCC寄託番号PTA−5130)のヒト化抗体;
(b)濃度0.1mM〜25mMのL−ヒスチジン;および
(c)1重量/容量%〜10重量/容量%のD−マンニトールを含んでなり、かつ、5.5〜6.5のpHを有する、単位剤形。 - ヒト化抗体が120mg〜160mgの量で存在する請求項5記載の単位剤形。
- (a)(i) 10mg〜250mgの量のモノクローナル抗体3D6(ATCC寄託番号PTA−5130)のヒト化抗体、
(ii) 濃度0.1mM〜25mMのL−ヒスチジン、
(iii)1重量/容量%〜10重量/容量%のD−マンニトール
を含み、かつ、5.5〜6.5のpHを有する、
ヒト化3D6抗体製剤を含有するガラスバイアル;および
(b)0.15mg/kg〜5mg/kgの用量を達成するために必要な適切な容量を使用するための使用説明書を含む使用のためのラベル
を含んでなる製薬学的製品。 - 請求項7記載の製薬学的製品において、
(a)(i) 100mgのモノクローナル抗体3D6(ATCC寄託番号PTA−5130)のヒト化抗体であって、配列番号1のアミノ酸配列を含む軽鎖および配列番号2のアミノ酸配列を含む重鎖を含んでなる抗体;、
(ii) 濃度10mMのL−ヒスチジン、
(iii)4重量/容量%のD−マンニトール、
(iv) 濃度10mMのメチオニン、および
(v) 0.005重量/容量%の量のポリソルベート80
を含み、かつ、6.0のpHを有する、
ヒト化3D6抗体製剤を含有するガラスバイアル;および
(b)0.5mg/kg〜3mg/kgの用量を達成するために必要な適切な容量を使用するための使用説明書を含む使用のためのラベル
を含んでなる、上記製薬学的製品。 - アミロイド形成性疾患の治療用の製薬学的製剤であって、該製剤が
(a)有効成分としての濃度1mg/ml〜100mg/mlのモノクローナル抗体3D6(ATCC寄託番号PTA−5130)のヒト化抗体;
(b)濃度0.1mM〜25mMのL−ヒスチジン;および
(c)1重量/容量%〜10重量/容量%のD−マンニトール
を含み、かつ、5.5〜6.5のpHを有し、そして患者に投与される前に滅菌等張生理食塩溶液で希釈されていてもよく、かつ、該製剤が、
既に該疾患に罹患している患者に投与されるものである、ことを特徴とする上記製薬学的製剤。 - 請求項9に記載の製薬学的製剤であって、該製剤が
(a)有効成分としての濃度20mg/mlのモノクローナル抗体3D6(ATCC寄託番号PTA−5130)のヒト化抗体であって、配列番号1のアミノ酸配列を含む軽鎖および配列番号2のアミノ酸配列を含む重鎖を含んでなる抗体;
(b)濃度10mMのL−ヒスチジン;
(c)4重量/容量%の量のD−マンニトール;
(d)濃度10mMのメチオニン;および
(e)0.005重量/容量%の量のポリソルベート80
を含んでなり、かつ、6.0のpHを有し、そして患者に投与される前に滅菌等張生理食塩溶液で希釈されていてもよく、かつ、該製剤の有効成分が患者における該疾患またはその合併症を部分的に阻止する量で投与されるものである、ことを特徴とする上記製薬学的製剤。 - アミロイド形成性疾患の予防用の製薬学的製剤であって、該製剤が
(a)有効成分としての濃度1mg/ml〜100mg/mlのモノクローナル抗体3D6(ATCC寄託番号PTA−5130)のヒト化抗体;
(b)濃度0.1mM〜25mMのL−ヒスチジン;および
(c)1重量/容量%〜10重量/容量%のD−マンニトール
を含み、かつ、5.5〜6.5のpHを有し、そして患者に投与される前に滅菌等張生理食塩溶液で希釈されていてもよく、かつ、該製剤が、
該疾患状態でない患者に投与され、該疾患の発症に対して少なくとも患者の抵抗性を高めるものである、ことを特徴とする上記製薬学的製剤。 - (a)30mg/ml〜100mg/mlのモノクローナル抗体3D6(ATCC寄託番号PTA−5130)のヒト化抗体を、1mg/ml〜2mg/mlのL−ヒスチジンおよび0.05mgのポリソルペート80と組み合わせて配合物を調製する工程、
(b)配合物のpHを6.0に調節する工程、
(c)配合物をクリオベッセル中に濾過する工程、および
(d)−50℃〜−80℃の温度で配合物を凍結乾燥する工程
を含んでなる、製薬学的製品の製造方法。 - 請求項12記載の製造方法であって、さらに、
(e)配合物を融解する工程、
(f)2mg/ml〜20mg/mlの該抗体、4重量/容量%のマンニトール、10mMのヒスチジンおよび0.005%のポリソルベートの最終濃度とするのに十分量のマンニトールを用いて該配合物を希釈する工程、
(g)希釈された配合物を濾過する工程、
(h)濾過された配合物をガラス容器中へ密封して滅菌製品を提供する工程、および
(i)2℃〜8℃の温度で滅菌製品を貯蔵する工程、
を含む上記方法。 - (a)濃度約1mg/ml〜約100mg/mlのモノクローナル抗体12B4のヒト化抗体であって、かつ、配列番号15、配列番号18および配列番号19よりなる群から選ばれるアミノ酸配列を含む軽鎖可変領域と配列番号19のアミノ酸配列を含む重鎖可変領域を含んでなる12B4抗体;
(b)濃度約0.1mM〜約25mMのL−ヒスチジン;および
(c)約1重量/容量%〜約10重量/容量%のD−マンニトール
を含み、かつ、約5.5〜6.5のpHを有する、配合物。 - (a)濃度約1mg/ml〜約100mg/mlの10D5(ATCC寄託番号PTA−5129)、266(ATCC寄託番号PTA−6123)、15C11(ATCC寄託番号PTA−7270)、9G8(ATCC寄託番号PTA−7201)、IC2(ATCC寄託番号PTA−7199)、2B1(ATCC寄託番号PTA−7202)、3A3(ATCC寄託番号PTA−7269)、2H3(ATCC寄託番号PTA−7267)および6C6(ATCC寄託番号PTA−7200)よりなる群から選ばれるモノクローナルAβ抗体のヒト化抗体;
(b)濃度約0.1mM〜約25mMのL−ヒスチジン;および
(c)約1重量/容量%〜約10重量/容量%の量のD−マンニトール、を含み、かつ、約5.5〜約6.5のpHを有する
配合物。
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 (ja) | 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 (30)
Country | Link |
---|---|
US (2) | US7635473B2 (ja) |
EP (2) | EP2392353A1 (ja) |
JP (1) | JP4977625B2 (ja) |
KR (1) | KR101188060B1 (ja) |
CN (2) | CN103768009B (ja) |
AR (1) | AR052198A1 (ja) |
AU (1) | AU2006211184B8 (ja) |
BR (1) | BRPI0607039A2 (ja) |
CA (1) | CA2593122C (ja) |
DK (1) | DK1853310T3 (ja) |
DO (1) | DOP2006000021A (ja) |
EA (2) | EA015147B1 (ja) |
ES (1) | ES2391407T3 (ja) |
GT (1) | GT200600031A (ja) |
HK (3) | HK1108132A1 (ja) |
IL (1) | IL184599A (ja) |
JO (1) | JO2740B1 (ja) |
MX (1) | MX2007009050A (ja) |
MY (1) | MY177052A (ja) |
NO (1) | NO20073305L (ja) |
NZ (1) | NZ556393A (ja) |
PE (1) | PE20060879A1 (ja) |
PL (1) | PL1853310T3 (ja) |
PT (1) | PT1853310E (ja) |
SI (1) | SI1853310T1 (ja) |
TW (1) | TWI398263B (ja) |
UA (1) | UA87549C2 (ja) |
UY (1) | UY29351A1 (ja) |
WO (1) | WO2006083689A2 (ja) |
ZA (1) | ZA200705710B (ja) |
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