Leading-Edge, Comprehensive Electronic Format Master Files for IL-2, IL-7, IL-15, and IL-21 Provide Transparency and Regulatory Support for Cell and Gene Therapy Developers
BOCA RATON, FL – July 1, 2020 – Akron Biotechnology, which develops and manufactures cGMP-compliant cytokines and other ancillary materials to enable cell and gene therapy development and commercialization, today announced that it has submitted Type II Drug Master Files (DMFs) in Electronic Common Technical Document (eCTD) with the U.S. Food and Drug Administration (FDA) for its Recombinant Human Interleukin-7, Interleukin-15, and Interleukin-21 (rHu IL-7, rHu IL-15, rHu IL-21).
Incorporating these DMFs into its portfolio, which already includes Recombinant Human Interleukin-2 (rHu-IL-2) among other ancillary materials, extends the company’s suite of DMFs covering cGMP-compliant cytokines for immunotherapy development and commercialization. Akron is the first ancillary material supplier to offer eCTD DMFs covering this set of cytokines, demonstrating the company’s commitment to enabling commercialization, even while much of the industry remains in clinical development.
The submission of these eCTD DMFs will enable a thorough assessment by regulators of the quality and consistency of Akron’s cGMP cytokines, assuring developers that the materials embedded in their manufacturing processes are sufficiently robust for further clinical development, and eventually for marketing approval. The availability of these robust documentation packages, coupled with Akron’s large-scale manufacturing capacity (grams per batch), situates the company in a unique position to support the market, especially while the industry experiences significant supply chain disruptions due to COVID-19.
“As cell and gene therapies advance through the clinical pipeline, it becomes increasingly important for developers to ensure the integrity of their ancillary materials. Regulators are looking more closely at what goes into these advanced therapies, and our DMFs provide them a clear view,” said Claudia Zylberberg, PhD, CEO of Akron Biotech. “As we partner with our customers on the journey towards commercial development, it’s our job to empower them to fly. The additional data and documentation made available in these eCTD format Master Files demonstrates the robustness and true commercial readiness of Akron’s cytokines, giving our customers confidence in their supply chain from the outset.”
Several clinical-stage companies supplied by Akron have already cross-referenced Akron DMFs in their regulatory filings. Companies can request a letter of authorization (LOA) from Akron, permitting the FDA to cross-reference the company’s DMFs as it assesses their filings. To learn more about Akron’s cGMP-compliant cytokines and DMFs, please visit www.akronbiotech.com or reach out via email@example.com.
About Akron Biotechnology
Akron is a leading materials manufacturer and services provider to the regenerative medicine industry, accelerating the development and commercialization of advanced therapies. Founded by Claudia Zylberberg, PhD, in 2006, Akron is an ISO 13485-certified company that operates in line with cGMPs and international standards, enabling advanced therapy developers to de-risk their supply chains and facilitate regulatory approval. The company’s unique business model emphasizes knowledge, flexibility and unparalleled service—from development through to commercialization. For more information, please visit www.akronbiotech.com.