Akron Announces Acceptance of Drug Master File for Interleukin-2 by the FDA
Sunday, April 03, 2016
Akron is pleased to announce acceptance by the Food and Drug Administration (FDA) of a Drug Master File (DMF) for our immunotherapy cytokine interleukin-2.
We invite all customers interested in cross-referencing our DMF for IL-2 in one of your submissions to government or regulatory agencies the FDA to contact us.
A few weeks ago, we wrote about Akron’s commitment to supporting immunotherapy advances through our capabilities in product and technology development which includes our sphisticated network of cytokines for research and clinical grade.
At the forefront of those is interleukin-2, which is fully documented and backed by an extensive dossier of data including extended stability and functionality documentation. You can get more information on our GMP-grade IL-2 here.
Now, we are pleased to announce the submission and acceptance by the FDA of a Drug Master File for Interleukin-2.
Drug Master Files are confidential documents submitted to the FDA which outline, in detail, manufacturing and procedural details for drugs or biological materials used in animals or humans.
DMFs were extensively described in one of our recent blog posts, and we invite you to read it here.
If you are interested in requesting a letter of authorization to reference our DMFs, please get in touch with us so that we may provide such authorization.
With IL-2 at the forefront, Akron also supplies a variety of other growth factors the roles of which are to enhance immunological response to clients that range from clinical-stage entities to research and development labs and academic institutions.
The acceptance of this DMF further confirms Akron’s continued commitment to quality and providing the highest level of support and transparency to our immunotherapy clients.