Demand for high quality and reliable plasmid manufacturing services has increased dramatically as DNA immunotherapy and gene therapies demonstrate success in clinical studies, said VGXI.
The contract development and manufacturing organization (CDMO) said the new purpose-built facility, located at Deison Technology Park in Conroe, Texas, will be perfectly positioned to meet such demand.
At the initial ground-breaking event in November last year, the subsidiary of South Korean DNA vaccine developer, GeneOne Life Science, said the site would be able to support a wide range of biopharma projects from early clinical trials through commercial supply production.
"VGXI specializes in production of plasmid DNA and RNA products for use in vaccines, immunotherapies, gene and cell therapies, and gene editing technologies. We have supported these industries with specialized CDMO services for over 20 years at our existing site in The Woodlands, Texas, and the facility in Conroe will be operational by April 2022 with greatly expanded capabilities," Christy Franco, senior manager, business development, VGXI, told BioPharma-Reporter this week.
The new facility offers multiple independent manufacturing suites with increased fermentation capacities up to the 1500L scale, and orders are now being taken for production slots starting in April 2022.
Both the headquarters and the production plant is now dried-in with multiple stages of equipment arriving for installation:
“Major mechanical equipment including air handlers, process chillers, and the sterile water filtration system components are arriving and being installed. In addition, full site backup generation will be complete this month, enabling uninterrupted power to the facility, independent of the electrical grid when required.
“The aggressive construction schedule will continue over the next several months with focus on interior mechanicals, installation of cleanroom suites and manufacturing equipment, and building finishes.”
Plasmid DNA investment trend
Other players have been investing in the plasmid DNA space this year.
Last month, AGC Biologics reported it was expanding its Heidelberg facility to create new capacity for messenger RNA (mRNA) projects, and to boost its plasmid-DNA (pDNA) manufacturing capabilities.
It operates multiple manufacturing lines and a variety of scales at the Heidelberg, Germany facility.
“The expansion will provide additional space that will be used to build a new small-scale production line for pDNA and mRNA, further enhancing our small-scale lines. The new capacity allows us to support small scale production of 10L and 50L for pDNA and [initiate] new projects for mRNA development,” a spokesperson for the CDMO told us.
In May, in a move to expand both its viral vector and pDNA manufacturing portfolio, Charles River acquired cell and gene therapy focused CDMO, Vigene Biosciences.
And February saw Wacker Chemie acquire Genopis from Helixmith and Medivate Partners, for US $39m, with it saying it would continue Genopis’ existing customer relationships as a CDMO for pDNA.