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Your Position: > FDA DMF 등록된 단백질

FDA DMF 등록 단백질 시리즈 제품

배경

DMF(Drug Master Files)는 보유자가 FDA에 제출한 보관된 약품 파일로, 주로 제품 품질 표준, 검사 방법, 생산 공정 설명, 순도 및 안정성과 같은 기밀 세부 정보를 포함합니다. 이러한 정보는 신약 신청( IND), 신약 등록(NDA) 및 생물학적 제제 허가 신청(BLA)을 지원하는 데 사용됩니다.

ACROBiosystems가 자체 개발한 재조합 단백질 제품 중 일부는 미국 FDA DMF 출원(FDA DMF 번호: 034936)을 완료했으며 관련 CAR-T 세포 트리몬트 제나 항체 약물 연구 프로젝트의 임상 신청 또는 신약 등록을 위한 규제 출원 문서에서 직접 DMF 번호를 응용할 수 있으므로 제품 검토 및 평가 시간을 절약하고 신약 임상 적용 준비시건을 단축할 수 있습니다.

DMF 번호 인용 승인:
ACRO의 DMF 파일링 시리즈 제품을 사용 중이고 DMF 번호를 인용해야 하는 경우 승인 신청서를 ACRO에 제출하시면 신청서 접수 후 FDA 센터에서 제공한 DMF 승인서를 보내드립니다. 승인 신청하기 클릭Request for Authorization

제품 특징
  1. 다양한 형태의 비표지, 형광 표지 및 비오틴화 단백질을 포함함.

  2. Flow cytometry, SPR, ELISA로 단백질 활성 확인됨.

  3. CAR 발현 검출 및 항체 약물 스크리닝에 적합됨.

제품 목록
분자 이름제품 번호제품 설명
CD19CD9-HF2H2FITC-Labeled Human CD19 (20-291) Protein, His Tag DMF Filed
CD9-HF251FITC-Labeled Human CD19 (20-291) Protein, Fc Tag DMF Filed
CD9-H8259Biotinylated Human CD19, Fc Tag, ultra sensitivity (primary amine labeling) DMF Filed
CD9-H52H2Human CD19 (20-291) Protein, His Tag DMF Filed
CD9-H5251Human CD19 (20-291) Protein, Fc Tag, low endotoxin (Super affinity, MALS verified) DMF Filed
CD9-HP2H3PE-Labeled Human CD19 (20-291) Protein, His Tag (Site-specific conjugation)
CD9-H82E9Biotinylated Human CD19 (20-291) Protein, His,Avitag™ (SPR verified)
BCMABCA-HF2H1FITC-Labeled Human BCMA / TNFRSF17 Protein, His Tag DMF Filed
BCA-HF254FITC-Labeled Human BCMA / TNFRSF17 Protein, Fc Tag DMF Filed
BCA-H82E4Biotinylated Human BCMA / TNFRSF17 Protein, His,Avitag™ DMF Filed
BC7-H82F0Biotinylated Human BCMA / TNFRSF17 Protein, Fc,Avitag™ DMF Filed
BCA-H522yHuman BCMA / TNFRSF17 Protein,His Tag (HPLC-verified) DMF Filed
BC7-H5254Human BCMA / TNFRSF17 Protein, Fc Tag (HPLC verified) DMF Filed
BCA-HP2H2PE-Labeled Human BCMA / TNFRSF17 Protein, His Tag (Site-specific conjugation)
FMC63FM3-Y45Monoclonal Anti-FMC63 scFv Antibody, Mouse IgG1 (Y45)
FM3-Y45A1Monoclonal Anti-FMC63 scFv Antibody, Mouse IgG1 (Y45) (Carrier-free) (recommended for ADA assay)
FM3-Y45P1Monoclonal Anti-FMC63 scFv Antibody, Mouse IgG1 (Y45) (HEK293)
FM3-FY45FITC-Labeled Monoclonal Anti-FMC63 scFv Antibody, Mouse IgG1 (Y45)
FM3-BY45Biotinylated Monoclonal Anti-FMC63 scFv Antibody, Mouse IgG1 (Y45)
FM3-BY54Biotinylated Monoclonal Anti-FMC63 scFv Antibody, Mouse IgG1, Avitag™ (Y45)
FM3-HPY53PE-Labeled Monoclonal Anti-FMC63 scFv Antibody, Mouse IgG1 (Y45) (Site-specific conjugation)
ROR1RO1-H5250Human / Cynomolgus / Rhesus macaque ROR1 Protein, Fc Tag (MALS verified)
Siglec-2CD2-H52H8Human Siglec-2 / CD22 Protein, His Tag (MALS verified)
MesothelinMSN-HP2H5PE-Labeled Human Mesothelin / MSLN (296-580) Protein, His Tag (Site-specific conjugation)
MSN-H82E9Biotinylated Human Mesothelin / MSLN (296-580) Protein, His,Avitag™ (MALS verified)
CD4LE3-H5228Human CD4 / LEU3 Protein, His Tag (MALS verified)
CD4-HF255FITC-Labeled Human CD4 Protein, Fc Tag
CD4-H5259Human CD4 Protein, Fc Tag (MALS verified)
EGFRvIIIEGI-HF2H7FITC-Labeled Human EGFRvIII Protein, His Tag
EGFREGR-HF2H5FITC-Labeled Human EGF R Protein, His Tag
RBDSPD-M180Anti-SARS-CoV-2 RBD Potent Neutralizing Antibody, Human IgG1 (AM180)
NucleaseBEE-N3116GENIUS™Nuclease
PH20 / SPAM1PH0-H5225Human PH20 / SPAM1 Protein, His Tag (active enzyme)
제품 데이터
FITC 표지된 CD19 단백질은 항-CD19 CAR 발현을 특이적으로 검출할수 있다는 것을 유세포 분석에 의해 검증되었습니다.

293 cells were transfected with anti-CD19-scFv and RFP tag. 2e5 of the cells were stained with FITC-Labeled Human CD19 (20-291), Fc Tag (Cat. No. CD9-HF251, 10 µg/ml) and FITC-labeled protein control. Non-transfected 293 cells and FITC-labeled protein control were used as negative control. RFP was used to evaluate CAR (anti-CD19-scFv) expression and FITC was used to evaluate the binding activity of FITC-Labeled Human CD19, Fc Tag (Cat. No. CD9-HF251) (QC tested).

SPR로 검증된 Human CD19 단백질의 친화도 상수는 0.17 nM입니다.

Human CD19, Fc Tag, low endotoxin (Super affinity) (Cat. No. CD9-H5251) captured on CM5 chip via Anti-Human lgG Fc antibodies surface, can bind FMC63 MAb (mouse lgG2a) with an affinity constant of 0.17 nM as determined in a SPR assay (Biacore T200) (Routinely tested).

항-BCMA CAR 발현을 FITC-표지된 인간 BCMA 세포측정법으로 검출됩니다.

293 cells were transfected with anti-BCMA-scFv and RFP tag. 2e5 of the cells were stained with FITC-Labeled Human BCMA, His Tag (Cat. No. BCA-HF2H1, 1 µg/ml) and FITC-labeled protein control. Non-transfected 293 cells and FITC-labeled protein control were used as negative control. RFP was used to evaluate CAR (anti-BCMA-scFv) expression and FITC was used to evaluate the binding activity of FITC-Labeled Human BCMA, His Tag (Cat. No. BCA-HF2H1) (QC tested).

SPR로 인간 BCMA 단백질의 친화도 상수는  0.388 nM인 것으로 확인됩니다.

Anti-BCMA Neutralizing Antibody, Mouse IgG1 (Clone: AM43, Cat. No. BCA-M43) captured on CM5 chip via anti-mouse antibodies surface can bind Human BCMA, His Tag (Cat. No. BCA-H522y) with an affinity constant of 0.388 nM as determined in a SPR assay (Biacore T200) (Routinely tested).

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