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> Protéines enregistrées DMF à la FDA
Un Drug Master File (DMF) ou Autorisation de Mise sur le Marché (AMM) en France consiste en un enregistrement à la Food and Drug Administration (FDA) qui est utilisé pour fournir des informations confidentielles détaillées sur les installations, les processus ou les articles utilisés dans la fabrication, le traitement, le conditionnement et le stockage d'un ou de plusieurs médicaments à usage humain. Les informations contenues dans un DMF peuvent être utilisées pour étayer une demande d'autorisation d’essai clinique pour un nouveau médicament (IND), une demande d’autorisation de mise sur le marché d’un nouveau médicament (NDA) ou une demande de licence générale « produits biologiques » (BLA).
ACROBiosystems a soumis un DMF à la FDA pour une partie de ses protéines recombinantes, et enregistré sous le numéro de DMF 034936. Si vous avez utilisé ces protéines enregistrées DMF dans le processus de développement du médicament, vous pouvez citer ce numéro de DMF pour réduire le temps de préparation d’enregistrement des documents pour soutenir votre IND ou BLA.
Comment obtenir notre autorisation DMF ：
Si nos protéines déposées en DMF ont été utilisées dans votre processus de développement de médicaments, vous pouvez demander que nous fournissions une autorisation DMF à la FDA en soutien à une soumission ou à un enregistrement que vous avez effectué auprès de la FDA. Veuillez soumettre votre demande à ACROBiosystems en laissant vos informations ici.Demande d'autorisation
Des protéines biotinylées, marquées par fluorescence et non conjuguées sont disponibles.
Haute bioactivité vérifiée par FACS, RPS et ELISA avec protocole offert gratuitement.
Idéal pour détecter l'expression des CAR et le criblage des anticorps.
| Molécule | Cat. N° | Description du produit |
|---|---|---|
| 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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