Bionova Scientific, a full-service biologics contract development and manufacturing organisation (CDMO) and subsidiary of Asahi Kasei, has opened a 10,000 square-foot plasmid DNA (pDNA) development and production facility in The Woodlands, Texas.
Located less than 30 miles north of Houston, the new site will design, develop and manufacture research-grade pDNA materials to support the cell and gene therapy (CGT) sector. The company stated that it plans to offer clinical to commercial-scale Current Good Manufacturing Practice (CGMP) pDNA production from the facility by the fourth quarter of 2025.
According to Bionova Scientific, pDNA is a key starting material for advanced therapeutics, including mRNA and viral vector-based CGTs. The addition of pDNA capabilities builds on the company’s antibody and protein CDMO services, which are delivered from its flagship facility in the San Francisco Bay Area.
“Bionova added these highly sought-after pDNA capabilities in response to a persistent unmet need among the cell and gene therapy biopharma community. Completing this specialised facility on schedule is not only a milestone for our team, but a crucial step in ensuring our customers receive the reliable, timely support they need to meet their own deadlines,” said Darren Head, President and Chair of Bionova. “We chose The Woodlands because of its proximity to a growing number of CGT companies, and its location provides Bionova with access to the rapidly expanding CGT ecosystem here in the U.S. By aligning our capabilities with the needs of the CGT sector, we look forward to building lasting partnerships that accelerate the industry.”
Bionova Scientific said the expansion will allow it to broaden its portfolio of biotherapeutic modalities to serve more customers in the CGT market. The company noted that the global pharmaceutical market is projected to reach almost $3 trillion by 2033, creating opportunities for scaled capacity in advanced therapies.
As part of Asahi Kasei’s Life Science group, Bionova Scientific is expanding its presence in line with the parent company’s medium-term management plan, which includes growth in virus filtration, contract research organisation (CRO) testing, and CDMO services. The company stated that continued investment in specialised capabilities will support its role in delivering manufacturing solutions for next-generation therapies.