KR20010099899A - Ctla-4에 대한 인간 단일클론 항체 - Google Patents
Ctla-4에 대한 인간 단일클론 항체 Download PDFInfo
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- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
- C07K16/18—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
- C07K16/28—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
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- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
- C07K16/18—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
- C07K16/28—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
- C07K16/2803—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against the immunoglobulin superfamily
- C07K16/2818—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against the immunoglobulin superfamily against CD28 or CD152
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P35/00—Antineoplastic agents
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P37/00—Drugs for immunological or allergic disorders
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P37/00—Drugs for immunological or allergic disorders
- A61P37/02—Immunomodulators
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P37/00—Drugs for immunological or allergic disorders
- A61P37/02—Immunomodulators
- A61P37/04—Immunostimulants
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- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K2317/00—Immunoglobulins specific features
- C07K2317/20—Immunoglobulins specific features characterized by taxonomic origin
- C07K2317/21—Immunoglobulins specific features characterized by taxonomic origin from primates, e.g. man
Abstract
Description
카테고리 | 항체 | CTLA-4 결합에 대한 경쟁 |
A | B01M* | 서로 자유롭게 교차 경쟁함; 카테고리 B와 교차 경쟁; 일부는 카테고리 D와 교차 경쟁 |
B02M** | ||
B | 4.1.1 | 서로 자유롭게 교차 경쟁함; 카테고리 A, C 및 D와 교차 경쟁 |
4.13.1 | ||
C | 6.1.1 | 서로 자유롭게 교차 경쟁함; 카테고리 B 및 C와 교차 경쟁 |
3.1.1 | ||
4.8.1 | ||
11.2.1 | ||
11.6.1 | ||
11.7.1 | ||
D | 4.14.3 | 카테고리 C 및 B와 교차 경쟁; 일부는 카테고리 A와 교차 경쟁 |
E | 4.9.1 | BNI3은 CTLA4에 대한 4.9.1 결합을 차단하지만, 그 역은 성립하지 않음 |
BNI3*** | ||
(*)(**) 바이오스트라이드에서 입수가능(***) 파미겐에서 입수가능 |
분석 | mAb | 시토킨 | 평균 증가(pg/㎖) | SEM | 증가 범위(pg/㎖) | n | 반응 공여체 |
T 세포 아세포/라지 | 4.1.1 | IL-2 | 3329 | 408 | 0∼8861 | 42 | 21 공여체 중 19 |
T 세포 아세포/라지 | 4.1.1 | IFN-γ | 3630 | 980 | 600∼13939 | 17 | 13 공여체 중 13 |
T 세포 아세포/라지 | 11.2.1 | IL-2 | 3509 | 488 | 369∼6424 | 18 | 14 공여체 중 14 |
SEA(PBMC) | 4.1.1 | IL-2 | 2800 | 312 | 330∼6699 | 42 | 17 공여체 중 17 |
SEA(PBMC) | 11.2.1 | IL-2 | 2438 | 366 | 147∼8360 | 25 | 15 공여체 중 15 |
SEA(전혈) | 4.1.1 | IL-2 | 6089 | 665 | -168∼18417 | 46 | 17 공여체 중 15 |
SEA(전혈) | 11.2.1 | IL-2 | 6935 | 700 | -111∼11803 | 25 | 14 공여체 중 12 |
Claims (104)
- 인간 VH3-33 계열 유전자가 암호화하는 FR1 서열 내지 FR3 서열내에서 유래한 인접 아미노산 서열을 포함하고, 도 2에 제시된 CDR1 서열, CDR2 서열 또는 골격 서열내의 아미노산 치환 중 하나 이상을 포함하는 중쇄 가변부 아미노산 서열을 포함하는 CTLA-4와 결합할 수 있는 항체.
- 제1항에 있어서, 아미노산 서열이 서열 번호 1, 서열 번호 2, 서열 번호 3, 서열 번호 4, 서열 번호 5, 서열 번호 6, 서열 번호 8, 서열 번호 9, 서열 번호 10, 서열 번호 11, 서열 번호 l2, 서열 번호 13, 서열 번호 63, 서열 번호 64, 서열 번호 66, 서열 번호 68, 및 서열 번호 70으로 구성된 군에서 선택된 서열을 포함하는 것이 특징인 항체.
- 제1항에 있어서, 서열 번호 14, 서열 번호 15, 서열 번호 16, 서열 번호 17, 서열 번호 18, 서열 번호 19, 서열 번호 20, 서열 번호 21, 서열 번호 22, 서열 번호 23, 서열 번호 24, 서열 번호 25, 서열 번호 26, 서열 번호 65, 서열 번호 67, 서열 번호 69, 및 서열 번호 71을 포함하는 서열로 구성된 군에서 선택된 서열을 포함하는 경쇄 가변부 아미노산 서열을 추가로 포함하는 것이 특징인 항체.
- 제2항에 있어서, 서열 번호 14, 서열 번호 15, 서열 번호 16, 서열 번호 17,서열 번호 18, 서열 번호 19, 서열 번호 20, 서열 번호 21, 서열 번호 22, 서열 번호 23, 서열 번호 24, 서열 번호 25, 서열 번호 26, 서열 번호 65, 서열 번호 67, 서열 번호 69 및 서열 번호 71을 포함하는 서열로 구성된 군에서 선택된 서열을 포함하는 경쇄 가변부 아미노산 서열을 추가로 포함하는 것이 특징인 항체.
- 서열 번호 1을 포함하는 중쇄 아미노산 서열과 서열 번호 14를 포함하는 경쇄 가변 아미노산 서열을 포함하는 항체.
- 서열 번호 2를 포함하는 중쇄 아미노산 서열과 서열 번호 15를 포함하는 경쇄 가변 아미노산 서열을 포함하는 항체.
- 서열 번호 4를 포함하는 중쇄 아미노산 서열과 서열 번호 17을 포함하는 경쇄 가변 아미노산 서열을 포함하는 항체.
- CTLA-4에 결합할 수 있는 분리된 인간 단일클론 항체.
- 제8항에 있어서, 상기 항체는 CTLA-4와 결합하기 위해서 3.1.1, 4.1.1, 4.8.1, 4.10.2, 4.13.1, 4.14.3, 6.1.1, 11.2.1, 11.6.1, 11.7.1, 12.3.1.1, 및 12.9.1.1로 구성된 군에서 선택된 항체와 경쟁할 수 있는 것이 특징인 항체.
- 제8항에 있어서, 상기 항체는 3.1.1, 4.1.1, 4.8.1, 4.10.2, 4.13.1, 4.14.3, 6.1.1, 11.2.1, 11.6.1, 11.7.1, 12.3.1.1, 및 12.9.1.1로 구성된 군에서 선택된 항체와 거의 유사한 CTLA-4에 대한 결합 특이성을 보유하는 것이 특징인 항체.
- 제8항에 있어서, 항체는 3.1.1, 4.1.1, 4.8.1, 4.10.2, 4.13.1, 4.14.3, 6.1.1, 11.2.1, 11.6.1, 11.7.1, 12.3.1.1, 및 12.9.1.1로 구성된 군에서 선택되는 것이 특징인 항체.
- 제8항에 있어서, 항체는 하등 포유류 종에서 유래한 CTLA-4와 교차 반응성이 없는 것이 특징인 항체.
- 제12항에 있어서, 하등 포유류 종은 마우스, 래트 및 토끼를 포함하는 것이 특징인 항체.
- 제8항에 있어서, 항체는 영장류에서 유래한 CTLA-4와 교차 반응성이 있는 것이 특징인 항체.
- 제14항에 있어서, 영장류는 게잡이 원숭이(cynomolgous) 및 붉은털 원숭이(rhesus)를 포함하는 것이 특징인 항체.
- 제8항에 있어서, 항체는 CD28, B7-2, CD44 및 hIgG1보다 CTLA-4에 대한 선택성이 약 100:1 이상인 것이 특징인 항체.
- 제16항에 있어서, 선택성은 약 500:1 이상인 것이 특징인 항체.
- 제8항에 있어서, 항체의 결합 친화도가 약 10-9M 이상인 것이 특징인 항체.
- 제18항에 있어서, 항체의 결합 친화도가 약 10-10M 이상인 것이 특징인 항체.
- 제8항에 있어서, 항체가 약 100 nM 이하의 IC50으로 CTLA-4와 B7-2 간의 결합을 저해하는 것이 특징인 항체.
- 제20항에 있어서, 항체가 약 0.38 nM 이하의 IC50으로 CTLA-4와 B7-2 간의 결합을 저해하는 것이 특징인 항체.
- 제8항에 있어서, 항체가 약 100 nM 이하의 IC50으로 CTLA-4와 B7-1 간의 결합을 저해하는 것이 특징인 항체.
- 제22항에 있어서, 항체가 약 0.50 nM 이하의 IC50으로 CTLA-4와 B7-1 간의 결합을 저해하는 것이 특징인 항체.
- 제8항에 있어서, 항체가 T 세포 아세포/라지 분석에서 IL-2 생성을 약 500 pg/㎖ 이상 증가시키는 것이 특징인 항체.
- 제24항에 있어서, 항체가 T 세포 아세포/라지 분석에서 IL-2 생성을 약 3846 pg/㎖ 이상 증가시키는 것이 특징인 항체.
- 제8항에 있어서, 항체가 T 세포 아세포/라지 분석에서 IFN-γ 생성을 약 500 pg/㎖ 이상 증가시키는 것이 특징인 항체.
- 제26항에 있어서, 항체가 T 세포 아세포/라지 분석에서 IFN-γ 생성을 약 1233 pg/㎖ 이상 증가시키는 것이 특징인 항체.
- 제8항에 있어서, 항체가 hPBMC 또는 전혈 초항원 분석에서 IL-2 생성을 약 500 pg/㎖ 이상 유도하는 것이 특징인 항체.
- 제26항에 있어서, 항체가 hPBMC 또는 전혈 초항원 분석에서 IL-2 생성을 약 1500 pg/㎖ 이상 유도하는 것이 특징인 항체.
- 제26항에 있어서, 항체가 hPBMC 또는 전혈 초항원 분석에서 대조군과 비교하여 IL-2 생성을 약 30% 이상 유도하는 것이 특징인 항체.
- 제26항에 있어서, 항체가 hPBMC 또는 전혈 초항원 분석에서 대조군과 비교하여 IL-2 생성을 약 50% 이상 유도하는 것이 특징인 항체.
- 3.1.1, 4.1.1, 4.8.1, 4.10.2, 4.13.1, 4.14.3, 6.1.1, 11.2.1, 11.6.1, 11.7.1, 12.3.1.1, 및 12.9.1.1로 구성된 군에서 선택된 항체와 거의 유사한 CTLA-4에 대한 결합 특이성을 보유하는 인간화된 항체.
- 제32항에 있어서, 항체는 하등 포유류 종에서 유래한 CTLA-4와 교차 반응하지 않는 것이 특징인 인간화된 항체.
- 제33항에 있어서, 하등 포유류 종은 마우스, 래트 및 토끼를 포함하는 것이 특징인 인간화된 항체.
- 제32항에 있어서, 항체는 영장류에서 유래한 CTLA-4와 교차 반응성이 있는것이 특징인 인간화된 항체.
- 제35항에 있어서, 영장류가 게잡이 원숭이 및 붉은털 원숭이를 포함하는 것이 특징인 인간화된 항체.
- 제32항에 있어서, 항체가 CD28, B7-2, CD44 및 hIgG1보다 CTLA-4에 대한 선택성이 약 100:1 이상인 것이 특징인 인간화된 항체.
- 제37항에 있어서, 선택성은 약 500:1 이상인 것이 특징인 인간화된 항체.
- 제32항에 있어서, 항체의 결합 친화도가 약 10-9M 이상인 것이 특징인 인간화된 항체.
- 제39항에 있어서, 항체의 결합 친화도가 약 10-10M 이상인 것이 특징인 인간화된 항체.
- 제32항에 있어서, 항체가 약 100 nM 이하의 IC50으로 CTLA-4와 B7-2 간의 결합을 저해하는 것이 특징인 인간화된 항체.
- 제41항에 있어서, 항체가 약 0.38 nM 이하의 IC50으로 CTLA-4와 B7-2 간의 결합을 저해하는 것이 특징인 인간화된 항체.
- 제32항에 있어서, 항체가 약 100 nM 이하의 IC50으로 CTLA-4와 B7-1 간의 결합을 저해하는 것이 특징인 인간화된 항체.
- 제43항에 있어서, 항체가 약 0.50 nM 이하의 IC50으로 CTLA-4와 B7-1 간의 결합을 저해하는 것이 특징인 인간화된 항체.
- 제32항에 있어서, 항체가 T 세포 아세포/라지 분석에서 IL-2 생성을 약 500 pg/㎖ 이상 증가시키는 것이 특징인 인간화된 항체.
- 제45항에 있어서, 항체가 T 세포 아세포/라지 분석에서 IL-2 생성을 약 3846 pg/㎖ 이상 증가시키는 것이 특징인 인간화된 항체.
- 제32항에 있어서, 항체가 T 세포 아세포/라지 분석에서 IFN-γ 생성을 약 500 pg/㎖ 이상 증가시키는 것이 특징인 인간화된 항체.
- 제47항에 있어서, 항체가 T 세포 아세포/라지 분석에서 IFN-γ 생성을 약1233 pg/㎖ 이상 증가시키는 것이 특징인 인간화된 항체.
- 제32항에 있어서, 항체가 hPBMC 또는 전혈 초항원 분석에서 IL-2 생성을 약 500 pg/㎖ 이상 증가시키는 것이 특징인 인간화된 항체.
- 제49항에 있어서, 항체가 hPBMC 또는 전혈 초항원 분석에서 IL-2 생성을 약 1500 pg/㎖ 이상 증가시키는 것이 특징인 인간화된 항체.
- 제32항에 있어서, 항체가 hPBMC 또는 전혈 초항원 분석에서 대조군과 비교하여 IL-2 생성을 약 30% 이상 증가시키는 것이 특징인 인간화된 항체.
- 제50항에 있어서, 항체가 hPBMC 또는 전혈 초항원 분석에서 대조군과 비교하여 약 50% 이상 IL-2 생성을 증가시키는 것이 특징인 인간화된 항체.
- 도 2에 제시된 CDR1, CDR2 및 CDR3 서열로부터 각각 선택된 CDR1, CDR2 및 CDR3 서열과 프레임내에서 작동가능하게 결합된 인간 VH3-33 유전자 계열이 암호화하는 인간 FR1, FR2 및 FR3 서열을 포함하는 중쇄 아미노산 서열을 포함하는, CTLA-4에 결합하는 항체.
- 제32항에 있어서, 도 2에 제시된 FR1, FR2 및 FR3 서열에 대한 임의의 체세포 돌연변이를 추가로 포함하는 것이 특징인 인간화된 항체.
- CDR1, CDR2 및 CDR3 서열과 프레임내에서 작동가능하게 결합된 인간 VH3-33 유전자 계열이 암호화하는 인간 FR1, FR2 및 FR3 서열을 포함하는 중쇄 아미노산 서열을 포함하고,CTLA-4에 대한 결합 친화도가 약 10-9이상이고;CTLA-4와 B7-1간의 결합을 약 100 nM 이하의 IC50으로 저해하며;CTLA-4와 B7-2간의 결합을 약 100 nM 이하의 IC50으로 저해하고;인간 T 세포 분석에서 시토킨 생성을 500 pg/㎖ 이상 증가시키는 특성들을 보유하는 것이 특징인 CTLA-4에 결합하는 항체.
- 도 2 및 도 3에 제시된 CDR1, CDR2 및 CDR3 서열로부터 각각 선택된 CDR1, CDR2 및 CDR3 서열과 프레임내에서 작동가능하게 결합된 FR1, FR2 및 FR3 서열을 포함하는 중쇄 아미노산 서열을 포함하고,CTLA-4에 대한 결합 친화도가 약 10-9이상이고;CTLA-4와 B7-1간의 결합을 약 100 nM 이하의 IC50으로 저해하며;CTLA-4와 B7-2간의 결합을 약 100 nM 이하의 IC50으로 저해하고;인간 T 세포 분석에서 시토킨 생성을 500 pg/㎖ 이상 증가시키는 특성들을보유하는 것이 특징인 CTLA-4에 결합하는 항체.
- 라지(Raji) 세포주와 동시 배양된 인간 T 세포 아세포의 배양물을 포함하는, T 세포 자극 분석용 세포 배양계.
- 제57항에 있어서, T 세포 아세포는 라지 세포주와 함께 배양하기 전에 세척되는 것이 특징인 세포 배양계.
- 인간 T 세포 아세포 및 라지 세포주의 배양물을 제공하는 단계;배양물을 제제와 접촉시키는 단계; 및배양물에 의한 시토킨 생성을 측정하는 단계를 포함하여 T 세포 자극을 측정하는 분석법.
- 제59항에 있어서, T 세포 아세포는 라지 세포주와 함께 배양하기 전에 세척되는 것이 특징인 분석법.
- 제59항에 있어서, 시토킨은 IL-2인 것이 특징인 분석법.
- 제59항에 있어서, 시토킨은 IFN-γ인 것이 특징인 분석법.
- 제59항에 있어서, 시토킨 생성은 배양물로부터 분리된 상청액에서 측정되는 것이 특징인 분석법.
- 제59항에 있어서, 제제는 항체인 것이 특징인 분석법.
- 제59항에 있어서, 항체는 CTLA-4에 결합하는 것이 특징인 분석법.
- 인간 T 세포 아세포 및 라지 세포주의 배양물을 제공하는 단계;배양물을 성분(moiety)과 접촉시키는 단계; 및배양물에 의한 시토킨 생성을 평가하는 단계를 포함하여 T 세포 자극 기능에 대해 성분을 스크리닝하는 기능 분석법.
- 제66항에 있어서, T 세포 아세포는 라지 세포주와 함께 배양하기 전에 세척되는 것이 특징인 기능 분석법.
- 제66항에 있어서, 시토킨은 IL-2인 것이 특징인 기능 분석법.
- 제66항에 있어서, 시토킨은 IFN-γ인 것이 특징인 기능 분석법.
- 제66항에 있어서, 시토킨 생성은 배양물로부터 분리된 상청액에서 평가되는것이 특징인 기능 분석법.
- 제66항에 있어서, 성분은 항체인 것이 특징인 기능 분석법.
- 제66항에 있어서, 항체는 CTLA-4에 결합하는 것이 특징인 기능 분석법.
- 인간 T 세포 아세포 및 라지 세포주를 포함하는 배양물을 제제와 접촉시키는 단계, 및 배양물에 의한 시토킨 생성을 평가하는 단계를 포함하는 CTLA-4 저해 기능에 대한 T 세포 자극 분석법.
- 제73항에 있어서, T 세포 아세포는 라지 세포주와 배양하기 전에 세척되는 것이 특징인 분석법.
- 제73항에 있어서, 시토킨은 IL-2인 것이 특징인 분석법.
- 제73항에 있어서, 시토킨은 IFN-γ인 것이 특징인 분석법.
- 제73항에 있어서, 시토킨 생성은 배양물로부터 분리된 상청액에서 평가되는 것이 특징인 분석법.
- 제73항에 있어서, 제제는 항체인 것이 특징인 분석법.
- 제73항에 있어서, 항체는 CTLA-4에 결합하는 것이 특징인 분석법.
- 인간 T 세포 아세포 및 라지 세포주를 포함하는 세포 배양물과 제제를 접촉시키는 단계; 및배양물에 의한 시토킨 생성을 평가하는 단계를 포함하는 T 세포 자극 활성에 대해 제제를 스크리닝하는 방법.
- 제80항에 있어서, T 세포 아세포는 라지 세포주와 함께 배양하기 전에 세척되는 것이 특징인 방법.
- 제80항에 있어서, 시토킨은 IL-2인 것이 특징인 방법.
- 제80항에 있어서, 시토킨은 IFN-γ인 것이 특징인 방법.
- 제80항에 있어서, 시토킨 생성은 배양물로부터 분리된 상청액에서 평가되는 것이 특징인 방법.
- 제80항에 있어서, 제제는 CTLA-4에 결합하는 항체인 것이 특징인 방법.
- 스타필로코커스 엔테로톡신 A로 자극한 인간 말초 혈액 단핵세포 또는 인간 전혈의 군을 제공하는 단계;배양물을 제제와 접촉시키는 단계; 및세포군에 의한 시토킨 생성을 측정하는 단계를 포함하여 T 세포 자극을 측정하는 분석법.
- 제86항에 있어서, 시토킨은 IL-2인 것이 특징인 분석법.
- 제86항에 있어서, 시토킨 생성은 세포군으로부터 분리된 상청액에서 측정되는 것이 특징인 분석법.
- 제86항에 있어서, 제제는 항체인 것이 특징인 분석법.
- 제86항에 있어서, 항체는 CTLA-4에 결합하는 것이 특징인 분석법.
- 스타필로코커스 엔테로톡신 A로 자극한 인간 말초 혈액 단핵세포 또는 인간 전혈의 군을 제공하는 단계;배양물을 성분과 접촉시키는 단계; 및세포군에 의한 시토킨 생성을 평가하는 단계를 포함하여 T 세포 자극 기능에 대해 성분을 스크리닝하는 기능 분석법.
- 제91항에 있어서, 시토킨은 IL-2인 것이 특징인 기능 분석법.
- 제91항에 있어서, 시토킨 생성은 세포군으로부터 분리된 상청액에서 평가되는 것이 특징인 기능 분석법.
- 제91항에 있어서, 성분은 항체인 것이 특징인 기능 분석법.
- 제91항에 있어서, 항체는 CTLA-4에 결합하는 것이 특징인 기능 분석법.
- 스타필로코커스 엔테로톡신 A로 자극한 인간 말초 혈액 단핵세포 또는 인간 전혈의 군을 제제와 접촉시키는 단계, 및 세포군에 의한 시토킨 생성을 평가하는 단계를 포함하는 CTLA-4 저해 기능에 대한 T 세포 자극 분석법.
- 제96항에 있어서, 시토킨은 IL-2인 것이 특징인 분석법.
- 제96항에 있어서, 시토킨 생성은 세포군으로부터 분리된 상청액에서 평가되는 것이 특징인 분석법.
- 제96항에 있어서, 제제는 항체인 것이 특징인 분석법.
- 제96항에 있어서, 항체는 CTLA-4에 결합하는 것이 특징인 분석법.
- 제제를 스타필로코커스 엔테로톡신 A로 자극한 인간 말초 혈액 단핵 세포 또는 인간 전혈의 군과 접촉시키는 단계; 및세포군에 의한 시토킨 생성을 평가하는 단계를 포함하여 T 세포 자극 활성에 대해 제제를 스크리닝하는 방법.
- 제101항에 있어서, 시토킨은 IL-2인 것이 특징인 방법.
- 제101항에 있어서, 시토킨 생성은 세포군으로부터 분리된 상청액에서 평가되는 것이 특징인 방법.
- 제101항에 있어서, 제제는 CTLA-4에 결합하는 항체인 것이 특징인 방법.
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KR1020057012533A KR100856446B1 (ko) | 1998-12-23 | 1999-12-23 | Ctla-4에 대한 인간 단일클론 항체 |
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