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
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.
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.
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