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> Proteínas archivadas en el DMF por la FDA
El archivo principal de medicamentos (DMF) es una presentación a la Administración de Alimentos y Medicamentos (FDA) que puede utilizarse para proporcionar información confidencial detallada sobre las instalaciones, los procesos o los artículos utilizados en la fabricación, el procesamiento, el envasado y el almacenamiento de uno o más medicamentos de uso humano. La información contenida en el DMF puede utilizarse para respaldar una solicitud de nuevo fármaco en investigación (IND), una solicitud de nuevo fármaco (NDA) o una solicitud de licencia biológica (BLA).
ACROBiosystems ha presentado a la FDA el DMF para parte de sus proteínas recombinantes, y ha presentado el número de DMF como 034936. Si ha estado utilizando estas proteínas archivadas en el DMF en el proceso de desarrollo del fármaco, puede citar este número de DMF para acortar el tiempo de preparación de la presentación de documentos para apoyar su IND o BLA.
Cómo obtener nuestra autorización DMF:
Si nuestras proteínas archivadas en el DMF se han utilizado en su proceso de desarrollo de medicamentos, puede solicitar que proporcionemos la autorización del DMF a la FDA en apoyo de una presentación o archivo que haya hecho a la FDA. Por favor, envíe su solicitud a ACROBiosystems dejando sus datos aquí.Solicitud de autorización
Están disponibles proteínas biotiniladas, etquetadas con fluorescencia y no conjugadas.
Alta bioactividad verificada por FACS, SPR y ELISA con protocolo ofrecido gratuitamente.
Ideal para detectar la expresión de CAR y el cribado de anticuerpos.
| Molécula | Cat. No. | Descripción del producto |
|---|---|---|
| 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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