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> FDA DMF 등록된 단백질
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
다양한 형태의 비표지, 형광 표지 및 비오틴화 단백질을 포함함.
Flow cytometry, SPR, ELISA로 단백질 활성 확인됨.
CAR 발현 검출 및 항체 약물 스크리닝에 적합됨.
| 분자 이름 | 제품 번호 | 제품 설명 | |
|---|---|---|---|
| CD19 | CD9-HF2H2 | FITC-Labeled Human CD19 (20-291) Protein, His Tag DMF Filed | |
| CD9-HF251 | FITC-Labeled Human CD19 (20-291) Protein, Fc Tag DMF Filed | ||
| CD9-H8259 | Biotinylated Human CD19, Fc Tag, ultra sensitivity (primary amine labeling) DMF Filed | ||
| CD9-H52H2 | Human CD19 (20-291) Protein, His Tag DMF Filed | ||
| CD9-H5251 | Human CD19 (20-291) Protein, Fc Tag, low endotoxin (Super affinity, MALS verified) DMF Filed | ||
| CD9-HP2H3 | PE-Labeled Human CD19 (20-291) Protein, His Tag (Site-specific conjugation) | ||
| CD9-H82E9 | Biotinylated Human CD19 (20-291) Protein, His,Avitag™ (SPR verified) | ||
| BCMA | BCA-HF2H1 | FITC-Labeled Human BCMA / TNFRSF17 Protein, His Tag DMF Filed | |
| BCA-HF254 | FITC-Labeled Human BCMA / TNFRSF17 Protein, Fc Tag DMF Filed | ||
| BCA-H82E4 | Biotinylated Human BCMA / TNFRSF17 Protein, His,Avitag™ DMF Filed | ||
| BC7-H82F0 | Biotinylated Human BCMA / TNFRSF17 Protein, Fc,Avitag™ DMF Filed | ||
| BCA-H522y | Human BCMA / TNFRSF17 Protein,His Tag (HPLC-verified) DMF Filed | ||
| BC7-H5254 | Human BCMA / TNFRSF17 Protein, Fc Tag (HPLC verified) DMF Filed | ||
| BCA-HP2H2 | PE-Labeled Human BCMA / TNFRSF17 Protein, His Tag (Site-specific conjugation) | ||
| FMC63 | FM3-Y45 | Monoclonal Anti-FMC63 scFv Antibody, Mouse IgG1 (Y45) | |
| FM3-Y45A1 | Monoclonal Anti-FMC63 scFv Antibody, Mouse IgG1 (Y45) (Carrier-free) (recommended for ADA assay) | ||
| FM3-Y45P1 | Monoclonal Anti-FMC63 scFv Antibody, Mouse IgG1 (Y45) (HEK293) | ||
| FM3-FY45 | FITC-Labeled Monoclonal Anti-FMC63 scFv Antibody, Mouse IgG1 (Y45) | ||
| FM3-BY54 | Biotinylated Monoclonal Anti-FMC63 scFv Antibody, Mouse IgG1, Avitag™ (Y45) | ||
| FM3-HPY53 | PE-Labeled Monoclonal Anti-FMC63 scFv Antibody, Mouse IgG1 (Y45) (Site-specific conjugation) | ||
| ROR1 | RO1-H5250 | Human / Cynomolgus / Rhesus macaque ROR1 Protein, Fc Tag (MALS verified) | |
| Siglec-2 | CD2-H52H8 | Human Siglec-2 / CD22 Protein, His Tag (MALS verified) | |
| Mesothelin | MSN-HP2H5 | PE-Labeled Human Mesothelin / MSLN (296-580) Protein, His Tag (Site-specific conjugation) | |
| MSN-H82E9 | Biotinylated Human Mesothelin / MSLN (296-580) Protein, His,Avitag™ (MALS verified) | ||
| CD4 | LE3-H5228 | Human CD4 / LEU3 Protein, His Tag (MALS verified) | |
| CD4-HF255 | FITC-Labeled Human CD4 Protein, Fc Tag | ||
| CD4-H5259 | Human CD4 Protein, Fc Tag (MALS verified) | ||
| EGFRvIII | EGI-HF2H7 | FITC-Labeled Human EGFRvIII Protein, His Tag | |
| EGFR | EGR-HF2H5 | FITC-Labeled Human EGF R Protein, His Tag | |
| RBD | SPD-M180 | Anti-SARS-CoV-2 RBD Potent Neutralizing Antibody, Human IgG1 (AM180） | |
| Nuclease | GMP-NUES19 | GMP GENIUS™Nuclease DMF Filed | |
| PH20 / SPAM1 | PH0-H5225 | Human PH20 / SPAM1 Protein, His Tag (active enzyme) |
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).
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).
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).
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