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> FDA DMF registrierte Proteine
Das Drug Master File (DMF) ist ein Dokument, das bei der Food and Drug Administration (FDA) eingereicht wird und vertrauliche, detaillierte Informationen über Betriebsanlagen, Prozesse oder Artikel enthält, die bei der Herstellung, Verarbeitung, Verpackung und Lagerung eines oder mehrerer Humanarzneimittel verwendet werden. Die im DMF enthaltenen Informationen können zur Unterstützung einer Investigational New Drug Application (IND), einer New Drug Application (NDA) oder einer Biologics License Application (BLA) verwendet werden.
ACROBiosystems hat die DMF für einen Teil seiner rekombinanten Proteine bei der FDA eingereicht und die DMF-Nummer 034936 erhalten. Wenn Sie diese im DMF registrierten Proteine in der Arzneimittelentwicklung verwendet haben, können Sie diese DMF-Nummer angeben, um die Vorbereitungszeit für die Einreichung der Dokumente zur Unterstützung Ihrer IND oder BLA zu verkürzen.
Wie erlangen Sie unsere DMF-Genehmigung:
Wenn unsere im DMF registrierten Proteine in Ihrem Arzneimittelentwicklungsprozess verwendet wurden, können Sie uns bitten, der FDA eine DMF-Autorisierung zur Unterstützung Ihrer Beantragung oder Registrierung zu erteilen. Bitte übermitteln Sie Ihre Anfrage an ACROBiosystems, indem Sie hier Ihre Informationen hinterlassenAntrag auf Autorisierung
Biotinylierte, fluoreszenzmarkierte und unkonjugierte Proteine sind erhältlich.
Hohe Bioaktivität, bestätigt durch FACS, SPR und ELISA, Verfahrensbeschreibung kostenlos verfügbar.
Ideal für den Nachweis der CAR-Expression und das Screening von Antikörperwirkstoffen.
| Molekül | Kat. Nr. | Produktbeschreibung |
|---|---|---|
| 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-BY45 | Biotinylated 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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