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FDA DMF Filed Proteins

Background

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 its recombinant CD19 and BCMA 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

Product Features
  1. Biotinylated, fluorescent-labeled and unconjugated proteins are available.

  2. High bioactivity verified by FACS, SPR and ELISA with protocol offered for free.

  3. Ideal for detecting CAR expression and antibody drug screening.

Product List
MoleculeCat.No.Product Description
CD19CD9-HF2H2FITC-Labeled Human CD19  Protein, His Tag, DMF Filed
CD9-HF251FITC-Labeled Human CD19  Protein, Fc Tag, DMF Filed
CD9-H8259Biotinylated Human CD19, Fc Tag, ultra sensitivity, DMF Filed
CD9-H52H2Human CD19  Protein, His Tag, DMF Filed
CD9-H5251Human CD19 Protein, Fc Tag, low endotoxin (Super affinity), DMF Filed
BCMABCA-HF2H1FITC-Labeled Human BCMA Protein, His Tag, DMF Filed
BCA-HF254FITC-Labeled Human BCMA Protein, Fc Tag, DMF Filed
BCA-H82E4Biotinylated Human BCMA Protein, His,Avitag™, DMF Filed
BC7-H82F0Biotinylated Human BCMA  Protein, Fc,Avitag™, DMF Filed
BCA-H522yHuman BCMA Protein,His Tag, DMF Filed
BC7-H5254Human BCMA  Protein, Fc Tag (HPLC verified), DMF Filed
>>> If you have FDA DMF filing request for other products, please contact us. Click here
Product Validation Data
Detection of Anti-CD19 CAR Expression by FACS

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).

The affinity constant of human CD19 protein was 0.17nM as verified by SPR

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).

FACS Analysis of Anti-BCMA CAR Expression

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).

High Affinity Verified by SPR

Anti-BCMA Neutralizing Antibody, Mouse IgG1 (Clone: AM43, Cat. No. BCA-M43) captured on CM5 chip via anti-mouse antibodies surface can bind Human BCMA, His Tag (Cat. No. BCA-H522y) with an affinity constant of 0.388 nM as determined in a SPR assay (Biacore T200) (Routinely tested).

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