FDA DMF Filed Proteins

 

Category: *CDMO

Exhibitor: ACROBIOSYSTEMS CO., LTD.

Booth No: M1033

 

Characteristic

 

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.
ACRO's DMF Filed Proteins:
CD19, BCMA, FMC63, ROR1, Siglec-2, Mesothelin, CD4, EGFRvIII, EGFR, RBD, Nuclease, PH20 / SPAM1

If you have FDA DMF filing request for other products, please contact us.

 

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