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Installation of FlexFactory will enable Akron to alleviate constraints in the supply of
critical materials for cell and gene therapy manufacturing. This will be the first Cytiva FlexFactory to be used in the manufacture of plasmid DNA

Cytiva, a global life sciences leader, will provide its FlexFactory to Akron Biotech, a leading
provider of cGMP-compliant solutions to support advanced therapy development. FlexFactory is
a flexible, single-use platform that will enable Akron Biotech to manufacture plasmid DNA
(pDNA), a critical component in many innovative therapies and vaccines.

The challenges presented by the global COVID-19 pandemic have fueled accelerated growth in
advanced therapeutics.¹ More than 50 percent of biomanufacturers expect to experience
moderate to severe capacity constraints at commercial scale by 2025.² This gap will likely
continue to widen with more than 1,000 regenerative clinical trials underway globally.¹ Critical
bottlenecks in the advanced therapy supply chain will need to be addressed to enable the
commercialization of these novel therapies.

Claudia Zylberberg, CEO, Akron Biotech, says: “With this partnership, Akron demonstrates its
continued commitment to supporting the advancement of cell and gene therapies with cGMP compliant
solutions at industrial scale.” She continues, “the FlexFactory from Cytiva will allow us
to address the growing need for high-quality, compliant plasmid DNA.”

Olivier Loeillot, Senior Vice President, Bioprocess, says, “With the accelerated growth of the
biotechnology industry, companies must choose technologies and solutions that can quickly
scale to meet future needs. Cytiva’s FlexFactory provides the speed and flexibility combined
with the automation platform needed to meet the needs of such a dynamic market.”

While this is Cytiva’s first FlexFactory installation for the manufacture of pDNA, there are more
than 70 FlexFactory installations around the world accelerating research, clinical trials and
commercial production of advanced and novel therapeutics and vaccines. The versatile
FlexFactory platform will continue to adapt to the workflows needed for developing
technologies that support innovative therapies.

The FlexFactory is designed to be used in cGMP (good manufacturing practices) manufacturing and provides traceability and optimization by combining control, connectivity, automation, and supporting services that accelerate manufacturing. Akron’s pDNA FlexFactory will be fully operational by Q3 2021. As part of the FlexFactory agreement, Cytiva and Akron are working together on process design for plasmid DNA production.

1 Alliance for Regenerative Medicine H1 2020 report
2 BioPlan 17th Annual Survey -April 2020 p 236

About Cytiva
Cytiva is a global life sciences leader with more than 7,000 associates across 40 countries dedicated to advancing and accelerating therapeutics. As a trusted partner to customers that range in scale and scope, Cytiva brings speed, efficiency and capacity to research and manufacturing workflows, enabling the development, manufacture and delivery of transformative medicines to patients.

About Akron Biotechnology
Akron is a leading provider of cGMP-compliant solutions to support advanced therapy commercialization. An ISO 13485-certified company operating in line with cGMP guidelines and international standards, Akron leverages more than 100,000 square feet of development and manufacturing capacity to provide therapy developers the scale, compliance, and regulatory support necessary to drive novel treatments from discovery to commercialization. For more information, please visit www.akronbiotech.com.

BOCA RATON, FL – October 19, 2020 – Akron Biotechnology today announced it has signed an agreement with Synairgen plc (LSE: SNG) for the provision of SNG001, Synairgen’s wholly-owned inhaled interferon beta (IFN-beta) therapeutic candidate for the treatment of COVID-19 patients. Akron Biotech provides cGMP-compliant solutions to support the development and commercialization of advanced therapies.

Synairgen reported positive results from its Phase II trial of SNG001 in 101 hospitalized COVID-19 patients in July 2020, indicating that its inhaled IFN-beta could provide a valuable treatment option in the face of the global COVID-19 pandemic. Furthermore, the safety, biomarker, and efficacy data for SNG001 provided from the interim analysis of Synairgen’s Phase II COPD trial in September 2020 was supportive of the on-going development of SNG001 in COVID-19 patients.

Akron will support the future clinical and commercial development of SNG001 through the provision of its IFN-beta in Synairgen’s formulation. “Akron’s expertise in recombinant protein manufacturing and large-scale production capacity add significant value to our further development and commercialisation of SNG001,” commented Synairgen CEO Richard Marsden. “The ability to rapidly scale the production of SNG001 will allow Synairgen to meet expected clinical and commercial demand for the drug, ensuring that patients have access to this promising treatment.”

“The agreement with Synairgen reflects our ongoing commitment to meet the growing demand for validated, cGMP-compliant solutions to advance novel therapies,” said Claudia Zylberberg, PhD, Founder and CEO of Akron Biotech. “We are excited to support Synairgen in its quest to further this exciting treatment for COVID-19, bringing a promising new therapy to patients with few viable options.”

About Akron Biotechnology

Akron is a leading provider of cGMP-compliant solutions to support the development of advanced therapies. An ISO 13485-certified company operating in line with cGMP guidelines and international standards, Akron leverages more than 100,000 square feet of development and manufacturing capacity to provide therapy developers the scale, compliance, and regulatory support necessary to drive novel treatments from discovery to commercialization. For more information, please visit www.akronbiotech.com.

About Synairgen plc

Synairgen is a respiratory drug discovery and development company founded by University of Southampton Professors Stephen Holgate, Donna Davies and Ratko Djukanovic. The business, focused primarily on lung viral defense in asthma, COPD, and COVID-19, uses its differentiating human biology BioBank platform and world-renowned international academic KOL network to discover and develop novel therapies for respiratory disease. Synairgen is quoted on AIM (LSE: SNG). For more information about Synairgen, please see www.synairgen.com.

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.