Drug Master Files

Akron Biotech recently announced the submission of eCTD Drug Master Files for its immunotherapy portfolio of cGMP cytokines: IL-2, IL-7, IL-15, and IL-21. Click here for more on the news.  

What is a Drug Master File (DMF)?

A DMF provides detailed, confidential information about a product’s manufacturing, processing, packaging, and storage, including chemistry, raw materials, stability, purity, and more.

Used to support an Investigational New Drug (IND) application, Biologic License Application (BLA), New Drug Application (NDA), Abbreviated New Drug Application (ANDA), or another DMF.

Enables the manufacturer to protect intellectual property by allowing regulators at the FDA to review the contents of the DMF in support of a third party’s submission.

In line with the FDA’s submission requirements, Akron submits DMFs (Type II) in Electronic Common Technical Document (eCTD) format.

Referencing our DMFs in your regulatory filings

The FDA can cross-reference our DMFs in conjunction with your IND, BLA, NDA, or ANDA. A cross-reference can be initiated via a request for a Letter of Authorization (LOA).

The LOA is a written statement by the DMF holder permitting the FDA to refer to information in the file in support of another organization’s submission.

If you wish to request a LOA in the context of one or more of your regulatory submissions, please e-mail regulatory@akronbiotech.com and include the following information in your e-mail in order to expedite the process:

  • The Point of Contact for FDA at your Company or Institution
  • The Akron product (including catalogue number) you wish to reference
  • The submission type, the submission number and/or the name of the study

Once your request has been submitted, you will receive e-mail confirmation of receipt. Within 5-10 business days, an Akron representative will send you a copy of the LOA for inclusion in your regulatory submission.

Akron’s Current eCTD DMFs

  • Recombinant Human Interleukin-2 (rHu IL-2) - DMF#030268
  • Recombinant Human Interleukin-7 (rHu IL-7) - DMF#034942
  • Recombinant Human Interleukin-15 (rHu IL-15) - DMF#034994
  • Recombinant Human Interleukin-21 (IL-21) - DMF#032442
  • Human Serum Albumin (HSA) 25% - DMF#19354
  • Heparin Sodium - DMF#034860

Coming soon:

  • EPO
  • bFGF
  • Cryopreservation Media
  • Inquire about others