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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

Product Features

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.

FDA DMF Filed Product List

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)
Mesothelin	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)

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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 (20-291), Fc Tag (Cat. No. CD9-HF251) (QC tested).
Protocol

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

: Human CD19 (20-291), 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).
Protocol

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).
Protocol

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).
Protocol