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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 info@akronbiotech.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.

The Medicine Maker’s Power List 2020 celebrates the great minds that bring us innovation in small molecules, biopharmaceuticals, and advanced medicine. Dr. Claudia Zylberberg has been recognized for her work in the cell and gene therapy space. Click here to see the full list of 20 professionals driving the industry forward and saving lives by developing new medicines.

New Site in Sarasota, FL Increases Akron’s US Manufacturing Capacity for Cell and Gene Therapy Materials and Technologies

BOCA RATON, FL – March 30, 2020 — Akron Biotechnology, LLC (Akron Biotech), which develops and manufactures cGMP-compliant cytokines and other ancillary materials to enable cell and gene therapy development and commercialization, today announced its expansion to a second manufacturing facility in the US. Akron Biotech has acquired a state-of-the-art 60,000-square-foot biologics manufacturing site in Sarasota, FL, bolstering the company’s US capacity and strengthening its position as the industry’s premier ancillary materials supplier. The site will be operational later this year.

“We are expanding to meet the growing demand for validated, cGMP-compliant materials as the regenerative medicine and advanced therapy industry moves more and more products through late-stage clinical development and towards commercialization,” explained Claudia Zylberberg, PhD, Founder and CEO of Akron Biotech. “The new site will enable us to scale up our production capacity while remaining committed to providing our customers with high quality materials that allow them to deliver safe and effective cell and gene therapies.”

The Sarasota site will facilitate rapid growth in each of the company’s three main cGMP business verticals: cytokines and growth factors, growth and cryopreservation media, and viral inactivated human-derived media supplements. It also enables the company to add cGMP-compliant plasmid development and production to its custom development and manufacturing services, addressing one of the central bottlenecks in the cell and gene therapy industry.

In September 2019, Arcline Investment Management (“Arcline”), a private equity firm with $1.5 billion of committed capital, acquired a majority interest in Akron Biotech. Arcline is working with the Akron team to build new capabilities and expand manufacturing capacity, strengthening its portfolio of ancillary materials and development and manufacturing services. “Akron is an ideal partner in the cell and gene therapy space,” said Arcline.  “We are committed to accelerating the company’s growth as part of our dedication to the emergent regenerative medicine industry.”

Akron will continue to manufacture its flagship cytokine product portfolio (IL-2, IL-7, IL-15, IL-21, and others) at large scale and under cGMP compliance at its pharmaceutical manufacturing facility overseas. The company will retain its global headquarters and manufacturing facility in Boca Raton, FL. The Sarasota site will be configured to support the production of the company’s cGMP-compliant product portfolio, as well as to scale its media development services in addition to building its plasmid manufacturing capabilities.

About Arcline
Arcline is a private equity firm with $1.5 billion in capital, investing in niche, market-leading companies that it is passionate about growing. Arcline approaches investments from multiple perspectives but share a single vision – to identify and unlock the breakout potential in its companies. Some of the company’s primary interest areas include Life Sciences, Industrials, Technology and Specialty Chemicals.

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.

Paper published in Cytotherapy to propose framework for critical standardization of ATMP material regulation

Boca Raton, Florida, US, January 22, 2020 – Akron Biotechnology, a leading supplier of ancillary materials to the regenerative medicine industry, today announces the publication of a white paper proposing a new pragmatic, unified and staged approach for the qualification of ancillary materials for the manufacture of Advanced Therapy Medicinal Products (ATMPs).

The proposed approach aims to meet the needs of both regulators and ATMP developers. The three-staged model creates a progressive method to enhance the compliance and quality of ancillary materials used for manufacturing. It will also contribute to the management of high cost of goods in ancillary material manufacturing, where the major contributor to these costs stem from quality assurance and manufacturing requirements.

Several independent frameworks currently exist to manage quality of ancillary materials. These frameworks are guidelines and have no official regulatory oversight, some of which are appropriate for use in the ATMP market. Nonetheless, they are widely adopted by the industry, resulting in ancillary materials that are manufactured according to different interpretations of ‘manufactured under GMP’. Examples of these existing frameworks include a Technical ISO Document that was led by the Standard Coordinated Body (SCB) with the participation of Japan, UK, Germany and US, among others, as well as the guidance set forth in USP Chapter <1043>.

This proposed staged regulatory approach supports the harmonization of requirements for GMP production of ancillary materials for drug developers and manufacturers. The paper has been published in Cytotherapy entitled ‘Towards a common framework for defining ancillary material quality across the development spectrum’. Akron CEO, Dr. Claudia Zylberberg, one of the authors and the main driver behind this framework, believes that this approach will be welcomed by the broad community as it harmonizes and clarifies the Quality requirements for both ATMP developers and ancillary material manufacturers.

“The regulations around the development, efficacy and manufacture of the current generation of ATMPs are tightly controlled. However, regulatory harmonization around ancillary materials, the building blocks of ATMPs, is needed,” said Claudia Zylberberg, CEO, Akron Biotechnology. “This has led to a spectrum of interpretations resulting in inconsistencies in product quality and process qualifications.  Since ATMP final products cannot be sterilized, ancillary material guidelines need to evolve for the safety of patients, and we are committed to leading this effort. The framework proposed could balance interests concerning risk, safety, quality, efficacy, and cost of goods.”

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

Boca Raton, Florida, February 13, 2019 – 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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