JP2006515503A5 - - Google Patents
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- JP2006515503A5 JP2006515503A5 JP2004522465A JP2004522465A JP2006515503A5 JP 2006515503 A5 JP2006515503 A5 JP 2006515503A5 JP 2004522465 A JP2004522465 A JP 2004522465A JP 2004522465 A JP2004522465 A JP 2004522465A JP 2006515503 A5 JP2006515503 A5 JP 2006515503A5
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- 108090001123 antibodies Proteins 0.000 claims 50
- 102000004965 antibodies Human genes 0.000 claims 50
- 239000000203 mixture Substances 0.000 claims 48
- 150000007523 nucleic acids Chemical group 0.000 claims 34
- 229920001850 Nucleic acid sequence Polymers 0.000 claims 32
- 239000008194 pharmaceutical composition Substances 0.000 claims 10
- 238000004519 manufacturing process Methods 0.000 claims 9
- 230000000694 effects Effects 0.000 claims 8
- 239000000427 antigen Substances 0.000 claims 6
- 102000038129 antigens Human genes 0.000 claims 6
- 108091007172 antigens Proteins 0.000 claims 6
- 238000002825 functional assay Methods 0.000 claims 5
- 102000004169 proteins and genes Human genes 0.000 claims 3
- 108090000623 proteins and genes Proteins 0.000 claims 3
- 229940072221 IMMUNOGLOBULINS Drugs 0.000 claims 2
- 102000018358 Immunoglobulins Human genes 0.000 claims 2
- 108060003951 Immunoglobulins Proteins 0.000 claims 2
- 239000000969 carrier Substances 0.000 claims 2
- 238000004113 cell culture Methods 0.000 claims 2
- 238000003745 diagnosis Methods 0.000 claims 2
- 239000000539 dimer Substances 0.000 claims 2
- 201000010099 disease Diseases 0.000 claims 2
- 238000000034 method Methods 0.000 claims 2
- 108020004707 nucleic acids Proteins 0.000 claims 2
- 108010071919 Bispecific Antibodies Proteins 0.000 claims 1
- 102000007312 Recombinant Proteins Human genes 0.000 claims 1
- 108010033725 Recombinant Proteins Proteins 0.000 claims 1
- 229930002945 all-trans-retinaldehyde Natural products 0.000 claims 1
- 238000004166 bioassay Methods 0.000 claims 1
- 239000003814 drug Substances 0.000 claims 1
- 230000002207 retinal Effects 0.000 claims 1
- 235000020945 retinal Nutrition 0.000 claims 1
- 239000011604 retinal Substances 0.000 claims 1
- 201000000582 retinoblastoma Diseases 0.000 claims 1
- 241000894007 species Species 0.000 claims 1
- 239000000126 substance Substances 0.000 claims 1
- 210000001519 tissues Anatomy 0.000 claims 1
Claims (54)
- 抗体の混合物を組換え宿主において生産する方法であって、この方法が次の:
組換え宿主細胞において、少なくとも1種の軽鎖及び前記少なくとも1種の軽鎖と対合可能な少なくとも3種の異なる重鎖を暗号化する核酸配列、又は核酸配列群を発現させる工程
を含む、抗体混合物の生産方法。 - 前記組換え宿主細胞が、生産される抗体が共通の軽鎖を含むように、前記少なくとも3種の異なる重鎖と対合可能な共通の軽鎖を暗号化する核酸配列を含む、請求項1記載の方法。
- さらに、次の:
抗体を宿主細胞からか、又は宿主細胞培養物から回収する工程
を含む、請求項1又は2記載の方法。 - 前記混合物の抗体において重鎖−軽鎖の二量体を含む少なくとも2種の抗体が、異なる特異性及び/又は親和性を持つ、請求項1〜3のいずれか一項記載の方法。
- 前記組換え宿主細胞が、前記細胞において組換えタンパク質を暗号化する核酸を増幅させる必要なく、前記タンパク質の高−レベル発現が可能である、請求項1〜4のいずれか一項記載の方法。
- 前記細胞を、不死化されるか、又はアデノウイルスのE1配列により形質転換されるヒト胚性網膜細胞から導く、請求項1〜5のいずれか一項記載の方法。
- 前記宿主細胞をPER.C6細胞から導く、請求項6記載の方法。
- 抗体の混合物であって、請求項1〜7のいずれかの方法により得られ得、前記混合物が、抗体のアイソタイプIgG1、IgG2、IgG3、IgG4、IgA1、IgA2、IgD、IgE又はIgMを含む、混合物。
- 前記混合物において存在する抗体が、同じ抗原の異なるエピトープ及び/又は混合物を含む1種の抗原において存在する異なる抗原に結合する、請求項8記載の混合物。
- 組換え宿主細胞であって、軽鎖を暗号化する核酸配列及び抗体の少なくとも3種の異なる重鎖を暗号化する核酸配列を含み、前記軽鎖及び重鎖が対合可能である、宿主細胞。
- 薬学的組成物であって、組換え的に生産される抗体の混合物及び適切な担体を含み、少なくとも3種の異なる重鎖配列が組換え抗体の混合物において代表され、及び前記抗体の軽鎖が共通の配列を含む、薬学的組成物。
- 前記混合物が二重特異性抗体を含む、請求項11記載の薬学的組成物。
- 前記混合物の抗体が、請求項10記載の組換え宿主細胞により生産される、請求項11又は12記載の薬学的組成物。
- 少なくとも2種の前記抗体が異なる特異性を持つ、請求項11〜13のいずれか一項記載の薬学的組成物。
- 前記異なる特異性が同じ抗原上の異なるエピトープに向けられる、請求項14記載の薬学的組成物。
- 前記異なる特異性が、混合物を含む1種の抗原において存在する異なる抗原に向けられる、請求項14記載の薬学的組成物。
- 少なくとも2種の前記抗体が同じエピトープについての異なる親和性を持つ、請求項11〜13のいずれか一項記載の薬学的組成物。
- 前記組成物が、前記組成物において存在する各々の個々の抗体の効果よりも大きな効果を持ち、前記効果が機能的アッセイにおいて測定される、請求項11〜17のいずれか一項記載の薬学的組成物。
- 抗体の混合物を生産する少なくとも1種の宿主細胞クローンを識別するための方法であって、前記混合物の抗体が機能的アッセイに従う所望の効果を持ち、この方法が次の:
(i)宿主細胞に、少なくとも1種の軽鎖を暗号化する核酸配列及び少なくとも2種の異なる重鎖を暗号化する核酸配列を提供する工程であって、前記重鎖及び軽鎖が互いに対合可能な工程;
(ii)少なくとも1種のクローンの前記宿主細胞を、前記核酸配列の発現を助長する条件下に培養する工程;
(iii)前記少なくとも1種のクローンの宿主細胞を、機能的アッセイによる所望の効果を持つ抗体の混合物の生産について選別する工程;及び
(iv)所望の効果を持つ抗体の混合物を生産する少なくとも1種のクローンを識別する工程
を含む、方法。 - 前記宿主細胞が、生産される抗体が共通の軽鎖を含むように、前記少なくとも2種の異なる重鎖と対合可能な共通の軽鎖を暗号化する核酸配列を含む、請求項19記載の方法。
- 工程ii)における前記培養及び工程iii)における前記選別を、少なくとも2種のクローンで行う、請求項19又は20記載の方法。
- 工程ii)の前記培養及び/又は工程iii)の前記選別を、高−処理の手法を用いて行う、請求項19〜21のいずれか一項記載の方法。
- 前記宿主細胞が、前記細胞においてタンパク質を暗号化する核酸配列を増幅させる必要なく、前記タンパク質の高−レベル発現が可能である、請求項19〜22のいずれか一項記載の方法。
- 前記細胞を、不死化されるか、又はアデノウイルスのE1配列により形質転換されるヒト胚性網膜芽細胞腫から導く、請求項19〜23のいずれか一項記載の方法。
- 前記宿主細胞をPER.C6から導く、請求項24記載の方法。
- 前記混合物の抗体が、異なる特異性及び/又は親和性を持つ少なくとも2種の抗体を含む、請求項19〜25のいずれか一項記載の方法。
- 抗体の混合物を生産する方法であって、次の:
(i)請求項19〜26のいずれか一項記載の方法により識別される宿主細胞クローンを、少なくとも1種の軽鎖及び少なくとも2種の重鎖を暗号化する核酸の発現を助長する条件下に培養する工程
を含む、方法。 - さらに、次の:
(ii)抗体を、宿主細胞からか、又は宿主細胞培養物から回収する工程
を含む、請求項27記載の方法。 - 抗体の混合物であって、請求項27又は28記載の方法により得られ得る、混合物。
- 組換え宿主細胞を、抗体の混合物を生産するために作出する方法であって、この方法が次の:
前記宿主細胞中に、軽鎖を暗号化する核酸配列及び前記軽鎖と対合可能な少なくとも3種の異なる重鎖を暗号化する核酸配列を導入する工程であって、前記核酸配列を連続的にか、又は同時に導入する工程
を含む、方法。 - 組換え宿主細胞を、抗体の混合物を生産するために作出する方法であって、この方法が次の:
少なくとも3種の異なる重鎖を暗号化する核酸配列を、少なくとも2種の前記重鎖と対合可能な軽鎖を暗号化する核酸配列を含む組換え宿主細胞中に導入する工程
を含む、方法。 - トランスジェニックな非−ヒト動物又はトランスジェニック植物であって、軽鎖を暗号化する核酸配列及び前記軽鎖と対合可能な少なくとも2種の異なる重鎖を暗号化する核酸配列又は配列群を含み、前記軽鎖及び重鎖を暗号化する前記核酸配列が、組織−特異的プロモータの調節下にある、トランスジェニック非ヒト動物又はトランスジェニック植物。
- 抗体の混合物であって、請求項32記載のトランスジェニック動物又はトランスジェニック植物から得られ得る、混合物。
- 薬学的組成物であって、組換え的に生産される抗体の混合物及び適切な担体を含み、少なくとも2種の異なる重鎖が前記混合物の組換え的に生産される抗体において代表される、薬学的組成物。
- 前記混合物が二重特異性抗体を含む、請求項34記載の薬学的組成物。
- 抗体の混合物であって、少なくとも2種の異なる重鎖が、ヒトか、又は動物の対象物の処置又は診断における使用のために代表される、混合物。
- 抗体の混合物の使用であって、少なくとも2種の異なる重鎖が、ヒトか、又は動物の対象物においての疾病又は疾患の処置又は診断における使用のための薬剤の調製のために代表される、混合物の使用。
- 異なるアイソタイプを含む抗体の混合物を宿主細胞から生産するための方法であって、この方法が次の:
組換え宿主細胞において、軽鎖を暗号化する核酸配列及び前記軽鎖と対合可能な異なるアイソタイプの少なくとも2種の重鎖を暗号化する核酸配列を発現させる工程
を含む、方法。 - 前記アイソタイプが少なくともIgG及びIgAを含む、請求項38記載の方法。
- 所望の効果を持つ抗体の混合物を、機能的アッセイにおいて識別するための方法であって、次の:
i)抗体の混合物を機能的アッセイにおいて加える工程、及び
ii)前記混合物の効果を前記アッセイにおいて定める工程
を含み、前記混合物における抗体が共通の軽鎖を含む、方法。 - 前記混合物が、請求項10〜18のいずれか一項記載の組成物において含まれる、請求項40記載の方法。
- 少なくとも1種の前記軽鎖及び/又は重鎖群を暗号化する核酸配列又は配列群を得る工程が備わる方法が、少なくとも1種の抗体提示の選定工程を含む、請求項1〜7、19〜28、38及び39のいずれか一項記載の方法、又は請求項30又は31記載の組換え宿主細胞の作出方法。
- 標的に結合可能な抗体の混合物を生産するための方法であって、この方法が次の:
i)抗体を含む抗体提示ライブラリを、標的を含む物質と接触させる工程、ii)前記標的に結合する抗体を選定する少なくとも1種の工程、iii)前記標的に結合する少なくとも2種の抗体を識別する工程であって、前記少なくとも2種の抗体が共通の軽鎖を含む工程、iv)軽鎖を暗号化する核酸配列及び前記少なくとも2種の抗体の重鎖を暗号化する核酸配列又は核酸配列群を、宿主細胞中に導入する工程、v)前記宿主細胞のクローンを、前記核酸配列の発現を助長する条件下に培養する工程
を含む、方法。 - 抗体の混合物を組換え宿主において生産するための方法であって、この方法が次の:
組換え宿主細胞において、共通の軽鎖を暗号化する核酸配列、及び可変領域において異なり及び前記共通の軽鎖と対合可能な少なくとも2種の異なる重鎖を暗号化する核酸配列を発現させる工程であって、及び前記重鎖が、更に、それらの定常領域において、異なる重鎖の間の対合を減少させるか、又は防ぐのに十分に異なる工程
を包含する、方法。 - 前記重鎖が異なるアイソタイプである請求項44記載の方法。
- 前記異なるアイソタイプが少なくともIgG1及びIgG3を包含する、請求項45記載の方法。
- 前記異なるアイソタイプが少なくともIgG及びIgAのアイソタイプを包含する、請求項45記載の方法。
- 抗体の混合物であって、請求項44〜47のいずれか一項記載の方法により得られ得る、混合物。
- 二量体のIgAアイソタイプ{(IgA)2}抗体を含む抗体の混合物を組換え宿主において生産するための方法であって、少なくとも1部分の前記二量体IgA抗体が、異なる結合領域を各々の2種のIgAサブユニットにおいて持ち、この方法が次の:
組換え宿主細胞において、共通の軽鎖を暗号化する核酸配列、及び前記共通の軽鎖に対合可能なIgAアイソタイプの少なくとも2種の異なる重鎖を暗号化する核酸配列を発現させる工程
を含む、方法。 - 少なくとも2種の異なる特異性を持つIgM抗体を含む抗体の混合物を生産するための方法であって、この方法が、組換え宿主細胞において、共通の軽鎖を暗号化する核酸配列、及びIgMアイソタイプの少なくとも2種の異なる重鎖を暗号化する核酸配列を発現させる工程を含み、前記重鎖が前記共通の軽鎖と対合可能である、方法。
- IgA二量体、IgM五量体又はIgM六量体であって、少なくとも2種の異なる特異性を持つ、IgA二量体、IgM五量体又はIgM六量体。
- 免疫グロブリンの混合物を単一細胞から生産する、細胞の培養物であって、前記混合物が少なくとも3種の異なる重鎖を含む、培養物。
- さらに、前記培養物が、前記免疫グロブリンの混合物を、単一細胞から、20より多い集団倍加数の間生産する、請求項52記載の培養物。
- 少なくとも1種の前記軽鎖及び/又は重鎖群を暗号化する核酸配列又は配列群が、少なくとも1種の抗体提示の選定工程を含む方法によって得られる、請求項10記載の組換え宿主細胞、又は請求項32記載のトランスジェニック非ヒト動物又はトランスジェニック植物。
Applications Claiming Priority (7)
Application Number | Priority Date | Filing Date | Title |
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US39706602P | 2002-07-18 | 2002-07-18 | |
EP02077953 | 2002-07-18 | ||
EP02077953.4 | 2002-07-18 | ||
US60/397,066 | 2002-07-18 | ||
EPPCT/EP03/50201 | 2003-05-27 | ||
EPPCT/EP03/50201 | 2003-05-27 | ||
PCT/EP2003/007690 WO2004009618A2 (en) | 2002-07-18 | 2003-07-15 | Recombinant production of mixtures of antibodies |
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JP2011121054A Division JP6049239B2 (ja) | 2002-07-18 | 2011-05-30 | 宿主クローンの識別方法、抗体混合物の生産方法、組換え宿主細胞の作出方法、トランスジェニック非ヒト動物またはトランスジェニック植物、抗体の混合物、薬学的組成物、および抗体の混合物の使用 |
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JP2006515503A JP2006515503A (ja) | 2006-06-01 |
JP2006515503A5 true JP2006515503A5 (ja) | 2006-08-10 |
JP4836451B2 JP4836451B2 (ja) | 2011-12-14 |
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JP2004522465A Expired - Lifetime JP4836451B2 (ja) | 2002-07-18 | 2003-07-15 | 抗体混合物の組換え生産 |
JP2011121054A Expired - Lifetime JP6049239B2 (ja) | 2002-07-18 | 2011-05-30 | 宿主クローンの識別方法、抗体混合物の生産方法、組換え宿主細胞の作出方法、トランスジェニック非ヒト動物またはトランスジェニック植物、抗体の混合物、薬学的組成物、および抗体の混合物の使用 |
JP2014137927A Expired - Fee Related JP6166693B2 (ja) | 2002-07-18 | 2014-07-03 | 組換え宿主細胞の作成方法、薬学的組成物の生産方法、混合物としての抗体、その使用、組換え宿主細胞、薬学的組成物、混合物としての抗体の識別方法、および組換え宿主細胞の培養物 |
JP2016184803A Pending JP2016220696A (ja) | 2002-07-18 | 2016-09-21 | 宿主細胞クローンの識別方法および抗体混合物の生産方法 |
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JP2014137927A Expired - Fee Related JP6166693B2 (ja) | 2002-07-18 | 2014-07-03 | 組換え宿主細胞の作成方法、薬学的組成物の生産方法、混合物としての抗体、その使用、組換え宿主細胞、薬学的組成物、混合物としての抗体の識別方法、および組換え宿主細胞の培養物 |
JP2016184803A Pending JP2016220696A (ja) | 2002-07-18 | 2016-09-21 | 宿主細胞クローンの識別方法および抗体混合物の生産方法 |
Country Status (15)
Country | Link |
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US (9) | US7262028B2 (ja) |
EP (2) | EP1523496B1 (ja) |
JP (4) | JP4836451B2 (ja) |
CN (3) | CN101537180B (ja) |
AT (1) | ATE514717T1 (ja) |
AU (2) | AU2003250074B2 (ja) |
CA (3) | CA2492377C (ja) |
CY (1) | CY1111886T1 (ja) |
DK (2) | DK1523496T3 (ja) |
ES (2) | ES2442615T5 (ja) |
HK (1) | HK1070902A1 (ja) |
NZ (1) | NZ537277A (ja) |
PT (2) | PT2314629E (ja) |
SI (1) | SI1523496T1 (ja) |
WO (1) | WO2004009618A2 (ja) |
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