In light of the worldwide COVID-19 pandemic, as well as rapid advances in technology in other areas of plasmid based medicines, vaccines, and gene therapies, a worldwide bottleneck has been created due to the plasmid DNA supply chain. In response, five of the leading manufacturers have announced facility expansions to meet this growing need.

Thermo Fisher, Aldevron, Kaneka Eurogentec, VGXI, and Maravai Life Sciences are all ramping up their production capabilities to meet the worldwide demand for these building blocks of vaccine and gene therapy development.

“Many leading COVID-19 vaccine candidates require plasmids to manufacture, and if we’re going to manufacture 1 billion vaccines, that will require just over half the world’s available plasmid manufacturing for that one product,” said Michael Chambers, executive chairman and co-founder of Aldeveron.

Thermo Fisher’s new 67,000 square foot site in Carlsbad, California, will expand the company’s capability for cGMP plasmid DNA used as a critical raw material to develop and manufacture cell and gene-based therapy including life-saving cancer treatments and mRNA vaccines.

Mike Shafer, senior vice president and president, pharma services, said, “The race to develop new transformative cell and gene therapies and vaccines is outpacing supply of commercial-quality plasmid DNA that can be produced at scale. Our new state-of-the art site will not only tackle the supply bottleneck for our customers, but also uniquely positions us to deliver robust, end-to-end cell and gene therapy capabilities.”

Aldeveron is another plasmid DNA manufacturer scaling up production capacity to meet the increasing needs of gene therapy. Its new 189,000 square foot facility should help increase their plasmid capacity 10-fold. According to CEO Kevin Ballinger, “There aren’t many industries where there is currently more worldwide demand than capacity,” but that’s currently the case in regards to cGMP plasmid DNA.

VGXI CEO Young Park concurs, saying that “demand for high quality and reliable plasmid manufacturing services has increased dramatically as DNA immunotherapy and gene therapies demonstrate success in clinical studies.” VGXI has responded by investing $57 million to build out 123,000 square feet of new space to increase their capacity by 500% with continued rapid growth in facility and production capabilities.

Maravai LifeSciences has announced the launch of TriLink BioTechnologies’ plasmid DNA manufacturing services to simplify and accelerate production of cGMP-grade mRNA product for vaccine and therapeutic manufacturing.  Maravai LifeSciences CEO Carl Hull said, “The ability to work with an expert, end-to-end manufacturing partner such as TriLink comes at a critical time for the pharmaceutical industry, when global demand for mRNA is expected to exceed availability of cGMP-quality plasmid DNA.” Hull believes that TriLink “will dramatically reduce production timelines and overcome tech transfer bottlenecks by reducing or eliminating plasmid sourcing wait times that otherwise last months.”

In addition, Kaneka Eurogentec has received GMP accreditation for its new state-of-the-art facility, allowing large-scale production of new generations of medicine. This accreditation complements their current biopharmaceuticals production capacity to further expand the offer from clinical studies to commercialization with large scale production in a single-site facility.

In summary, rapid advances in gene technology, thousands of clinical trials underway, and the global COVID-19 pandemic have resulted in a bottleneck of wait times for plasmid DNA manufacturing, and these five companies are increasing capacity to meet that demand.