Master Files

What is a Master File (MF)?

An MF 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 MF.

MFs enable manufacturers to protect intellectual property by allowing regulators at the FDA to review the contents of the MF in support of a third party’s submission.

In line with the FDA’s submission requirements, Akron submits MFs (Type II) in electronic common technical document (eCTD) format.

Akron Bio’s Available eCTD MFs

  • Recombinant Human Interleukin-2 (rHu IL-2) - MF#026152 [MF Type I (#e2500890) on file with Health Canada]
  • Recombinant Human Interleukin-21 (rHu IL-21) - MF #026086
  • Recombinant Human Interleukin-7 (rHu IL-7) - MF #026084
  • Recombinant Human Interleukin-15 (rHu IL-15) - MF #026085
  • Recombinant Human Erythropoietin (rHu EPO) - MF #027160
  • Recombinant Human Insulin - MF #027051
  • Human Serum Albumin (HSA) 25% - MF#019354
  • Heparin Sodium Salt - MF #026153

Coming in 2021:
  • rHu G-CSF
  • rHu GM-CSF
  • rHu bFGF
  • rHu SCF
  • rHu IL-12
  • rHu IL-18
  • rHu PDGF-BB
  • Human AB Serum (Xeno-Free, Virus Inactivated), Human Fibronectin (Virus Inactivated)


Referencing our MFs in regulatory filings

The FDA can cross-reference our MFs in conjunction with your IND, BLA, NDA, or ANDA. A cross-reference can be initiated via a request for a Letter of Authorization (LOA). Health Canada can also cross-reference our MF Type I filed for rHu IL-2.

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

Submit a request for an LOA by using the form to the right of this page.

More on Quality

Quality at Akron

An Akron specialist will be in touch with you within 24 hours

*Indicates required field

By clicking submit below, you consent to allow Akron Biotech to store and process the personal information submitted above to provide you the content requested. For more information on our privacy practices and how we are committed to protecting and respecting your privacy, please review our Privacy Policy.

An Akron specialist will be in touch with you within 24 hours

*Indicates required field

By clicking submit below, you consent to allow Akron Biotech to store and process the personal information submitted above to provide you the content requested. For more information on our privacy practices and how we are committed to protecting and respecting your privacy, please review our Privacy Policy.