Akron Biotechnology, a biotechnology company based in the US, opened a manufacturing facility in the city of Sarasota in Florida, US, in April 2022, to produce plasmid DNA for addressing the critical demands in the rapidly growing gene therapy and vaccine markets.
Plasmid DNA is a crucial supplementary component employed in the production of advanced therapies.
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The facility expanded the company鈥檚 capacity for the production of ancillary materials to support its customers in the delivery of effective cell and gene therapies while strengthening its capability in the US. It is Akron鈥檚 second manufacturing site in the US and was developed in partnership with private equity company Arcline Investment Management.
Arcline bought a majority interest in Akron in September 2019. Dark Horse Consulting Group served as Arcline鈥檚 advisor for the investment.
The biologics manufacturing site was acquired by Akron from Cambryn Biologics in March 2020 to expand its manufacturing capacity in the US for cell and gene therapy materials and technologies.
Akron鈥檚 expansion in the US allows it to meet the rising demand for current good manufacturing practice (cGMP)-compliant materials in the regenerative medicine and advanced therapy industry to push products towards commercialisation.
Location
The facility is situated at 600 Tallevast Road in Sarasota in Manatee County. The location was chosen due to the presence of rapidly emerging biomedical hubs in the region and the support of local and state governments.
Details of Akron Biotech鈥檚 manufacturing facility
The state-of-the-art cGMP manufacturing facility is developed on a 60,000ft虏 site in Sarasota, Florida.
The facility enabled the growth of the company鈥檚 cGMP-compliant product portfolio primarily in three business units, including cytokines and growth factors, viral inactivated human-derived media supplements, and growth and cryopreservation media. It also ramped up the company鈥檚 media development services, while facilitating growth in plasmid production capacity.
The new site facilitates an increasing clinical development pipeline by aiding and securing industry supply.
The company uses the cGMP suite equipped with single-use bioreactors ranging from 22 litres, 50 litres, to 200 litres for manufacturing GMP plasmid DNA.
Ancillary materials
Ancillary materials are the substances and reagents utilised in the production of cell therapies but are mostly not present in the finished products. They are important components as they affect the quality and safety of cell therapies.
Akron filed a Drug Master File Type II for its Interleukin-2 (IL-2) in Electronic Common Technical Document format with the US Food and Drug Administration, in February 2019.
IL-2 is a crucial ancillary material required to produce cell-based immunotherapies.
Akron proposed a unified, three-stage approach for the qualification of the ancillary materials to meet the requirements of regulators as well as advanced therapy medicinal products developers in January 2020. The model could improve the quality and compliance of ancillary materials required for manufacturing while keeping the cost of the materials under control.
Akron Biotech鈥檚 existing facility in the US
Akron develops innovative materials for cell and gene therapy research, clinical development, and commercialisation in its 14,000ft虏 facility with laboratory and manufacturing space in Boca Raton in Florida, US. The manufacturing facility also serves as the company鈥檚 global headquarters.
Marketing commentary on Akron Biotechnology
Established in 2006, Akron Biotechnology focuses on developing products, technologies and services for cell and gene therapy and regenerative medicine industries. The International Organization for Standardization 13485-certified company manufactures its flagship cytokine product portfolio including IL-2, IL-7, IL-15, IL-21, and various other products at large scale.
Akron is a member of various institutes and organisations including the Alliance of Regenerative Medicine, International Society of Stem Cell Research, University of Miami, College of Engineering, Biomedical Engineering, International Society of Cell Therapy, BioFlorida, and National Academy of Science.
The company joined the Advanced Regenerative Manufacturing Institute (ARMI), an initiative of the Manufacturing USA network, in 2017. ARMI is a consortium of approximately 100 organisations from diverse backgrounds including academia, industry, government, and the non-profit sector for the development of advanced manufacturing technologies and procedures for engineered tissues and organs.
