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FDA DMF Filed Proteins
Drug master file (DMF) is a submission to the Food and Drug Administration (FDA) that may be used to provide confidential detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of one or more human drugs. The information contained in the DMF may be used to support an Investigational New Drug Application (IND), a New Drug Application (NDA), or Biologics License Application (BLA).
ACROBiosystems has submitted DMF for part of its recombinant proteins to FDA, and filed the DMF number as 034936. If you have been using these DMF filed proteins in the drug development process, you can cite this DMF number to shorten the time of preparing the filing of documents to support your IND or BLA.
How to get our DMF authorization:
If our DMF filed proteins have been used in your drug development process, you can request that we provide DMF authorization to FDA in support of a submission or filing that you have made to the FDA. Please submit your request to ACROBiosystems by leaving your information here.Request for Authorization
Biotinylated, fluorescent-labeled and unconjugated proteins are available.
High bioactivity verified by FACS, SPR and ELISA with protocol offered for free.
Ideal for detecting CAR expression and antibody drug screening.
Molecule | Cat. No. | Product Description |
---|---|---|
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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