Akron Biotech Submits eCTD Drug Master File for IL-2 with the FDA

New, more comprehensive electronic format to provide transparency and comparability support for advanced therapy developers

Akron Biotechnology, a leading supplier of ancillary materials to the regenerative medicine industry, announces that it has filed a Drug Master File (DMF) Type II for its Interleukin-2 (IL-2) in Electronic Common Technical Document (eCTD) format with the U.S. Food and Drug Administration (FDA).

Akron has long supported its customer base through DMF filings and therefore elected to update its IL-2 filing to the new electronic format in an effort to provide the more detailed and comprehensive information required by advanced therapy developers for their regulatory filings.

“As cell and gene therapy products expand into more complex target indications, it is increasingly important to manufacture with the highest quality materials, while gaining the maximum amount of visibility into the composition of those materials,” said Claudia Zylberberg, CEO of Akron Biotech. “These improvements will enable cell and gene therapy products to reach market, and therefore patients, more quickly, increasing their overall chance of clinical success.”

Akron is among the first in the industry to file an eCTD DMF for IL-2, a critical ancillary material in the production of cell-based immunotherapies. This advancement will have a broad-ranging impact for both research and commercial aspects of the market.

“It was important for Akron to be one of the first companies to supply IL-2 products with the additional data and documentation required by the eCTD format as we see our customers as partners on the journey towards commercial development,” Zylberberg added.

A significant part of developing and producing high-quality and compliant advanced therapies is the use of higher-grade ancillary materials and the security of supply of those materials. DMFs are essential for sponsors in that they verify the quality of ancillary materials, assuring developers that their production processes are scalable and consistent.

Referencing the highest quality DMFs has become a valuable strategy for developers to reduce the workload associated with material qualification, thereby accelerating approvals. A number of companies supplied by Akron have already referenced Akron DMFs in their regulatory filings.

About Akron Biotechnology

Akron Biotechnology is a leading supplier to the regenerative medicine industry. Akron develops and manufactures cGMP-compliant ancillary materials and provides specialized services in order to accelerate the clinical development and commercialization of advanced therapies. For more information, please visit us at www.akronbiotech.com.

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