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Toronto – February 24, 2021 – In this free webinar, the featured speakers will discuss the challenges posed by human blood-derived ancillary materials and the strategies employed by suppliers to mitigate these risks. Attendees will also learn about a layered approach to providing safe and effective therapeutic biologics.

As advanced therapy developers approach approval and commercialization, they adopt increasingly robust risk-based approaches to ancillary material qualification. Ancillary material qualification is defined by USP 1043 as “the process of acquiring and evaluating data to establish the source, identity, purity, biological safety, and overall suitability of a specific ancillary materials.”

As advanced therapies progress through the clinical pipeline, the integrity of the materials used during manufacture becomes increasingly critical. This session focuses on the challenges that human blood-derived ancillary materials pose, and on the strategies employed by suppliers to mitigate the potential risks they present.

These include extensive donor-screening practices and testing for infectious transmissible agents, the application of current good manufacturing practices (cGMP) during production, and the implementation of robust safety testing on the finished products. In addition, the implementation of virus inactivation processes offers an additional layer of safety as well as lot-to-lot consistency.

Join Robert Margolin, Vice President of Global Sales, Akron Biotech; Richard McFarland, PhD, President, Standards Coordinating Body for Gene, Cell, and Regenerative Medicines and Cell-Based Drug Discovery (SCB) & Chief Regulatory Officer, Advanced Regenerative Manufacturing Institute (ARMI); and Raymond Luke, Associate Director of Process Sciences (Manufacturing Science & Technology), Adaptimmune in a live webinar on Thursday, March 11, 2021 at 1pm EST.

For more information, or to register for this event, visit De-risking the Manufacturing of Cell Therapies through Virus-Inactivated Products.

About Akron Biotech

Akron is a leading materials manufacturer and services provider to the regenerative medicine industry. 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 advanced 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 XTalks

Xtalks, powered by Honeycomb Worldwide Inc., is a leading provider of educational webinars to the global life science, food and medical device community. Every year, thousands of industry practitioners (from life science, food and medical device companies, private & academic research institutions, healthcare centers, etc.) turn to Xtalks for access to quality content. Xtalks helps Life Science professionals stay current with industry developments, trends and regulations. Xtalks webinars also provide perspectives on key issues from top industry thought leaders and service providers.

To learn more about Xtalks visit xtalks.com.
For information about hosting a webinar visit xtalks.com/why-host-a-webinar.

Partnership Aims to Enhance Safety of Human Serum from Viruses Such as the Virus that Causes COVID-19

BOCA RATON, FL – January 20, 2021 – Akron Biotechnology, LLC (Akron Biotech), today announced it has signed an exclusive global agreement to manufacture virally inactivated Human AB Serum for the cell therapy market using Octaplas^®, Octapharma’s pooled, solvent-detergent treated human plasma. Akron Biotech is a leading manufacturer of cGMP-compliant ancillary materials for cell and gene therapy development and commercialization. Switzerland-based Octapharma is one of the largest human protein manufacturers in the world, developing and producing human proteins from human plasma and human cell lines.

Human AB Serum converted from plasma is a critical media supplement used in cell therapy manufacturing. These challenging times once again demonstrated the paramount role of patient safety. Therefore, starting with a virally inactivated, licensed pharmaceutical grade plasma product such as Octaplas^® can help to support research and development requirements with a view to eventual commercialization.

Under the agreement, Akron Biotech will produce Human AB Serum converted from Octaplas^®, which is Octapharma’s pooled, solvent/detergent treated human plasma product. The Octaplas^® viral inactivation and production process includes multiple independent, complementary, and validated steps to eliminate or reduce non-enveloped and enveloped viruses such as the novel viral agent SARS-CoV-2, the virus causing COVID-19. The products will be co-labeled and available in the US, EU, and Asia.

Guidance documents published by regulatory agencies around the world make clear that the highest quality raw and ancillary materials available should be employed in the manufacture of cell therapies, and that these materials should be thoroughly assessed and qualified through a comprehensive, risk-based approach. Viral inactivation of Human AB Serum promises to significantly reduce the risk of one of the more complex ancillary materials common in cell therapy manufacturing.

“After years of working with Octapharma, we are taking our relationship to the next level to create a powerful resource for the cell therapy market,” explained David Smith, President and Chief Commercial Officer at Akron Biotech. “The products that result from Octapharma’s plasma technologies and Akron Biotech’s manufacturing and commercialization will enable the global industry to move forward with greater confidence and safety.”

“Octapharma is proud to support the growing cell and gene therapy market with Octaplas^® converted materials,” notes Flemming Nielsen, President Octapharma USA, Inc. & Board Member Octapharma Group. Octaplas^® is manufactured with batch to batch consistency of plasma proteins and carries the added benefit of being virally inactivated with FDA approval (for intravenous infusion). With the continued advance of clinical and commercial cell therapies, it is increasingly important that the materials used are of the highest quality and safety standards available. This partnership coupled with Akron Biotech’s investment in state-of-the-art manufacturing facilities will be essential to support this growing market.

For more information on this partnership, and to learn more about Akron’s Human AB Serum converted from Octaplas^®, please reach out to info@akronbiotech.com.

About Akron Biotechnology

Akron is a leading materials manufacturer and services provider to the regenerative medicine industry. 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 advanced 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 Octapharma

Headquartered in Lachen, Switzerland, Octapharma is one of the largest human protein manufacturers in the world, developing and producing human proteins from human plasma and human cell lines. Octapharma employs more than 10,000 people and has seven R&D sites and six state-of-the-art manufacturing facilities in Austria, France, Germany, Mexico and Sweden.

In addition, Octapharma operates more than 140 plasma donation centers across Europe and the US. For more information, please visit www.octapharma.com and www.octaplasus.com.

More about this product: Human AB Serum, Converted from Octaplas^®, Pooled Plasma (Human), Xeno-Free, Virus Inactivated

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.