Cytiva will provide the first FlexFactory to be used in the manufacture of pDNA to Akron Bio.
Cytiva will provide its FlexFactory, a flexible, single-use platform, to enable Akron Biotech to manufacture plasmid DNA (pDNA), which is used in many innovative therapies and vaccines, Cytiva said in an Oct. 15, 2020 press release. Cytiva and Akron will also work together on process design for pDNA production. Akron’s pDNA FlexFactory will be fully operational by the third quarter of 2021, the press release said.
“With this partnership, Akron demonstrates its continued commitment to supporting the advancement of cell and gene therapies with cGMP [current good manufacturing practice]-compliant solutions at industrial scale,” said Claudia Zylberberg, CEO, Akron Biotech, in the press release.
Materials for cell and gene therapy manufacturing, such as pDNA, have been experiencing capacity constraints, and the platform will enable rapid scale-up to address supply chain bottlenecks.
“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,” said Olivier Loeillot, senior vice-president, Bioprocess, Cytiva, in the press release.
This is Cytiva’s first FlexFactory installation for the manufacture of pDNA. More than 70 FlexFactory installations around the world are already in use for clinical trials and commercial production of advanced and novel therapeutics and vaccines. The FlexFactory, designed for cGMP manufacturing, provides traceability and optimization by combining control, connectivity, automation, and supporting services that accelerate manufacturing, according to the press release.