Asahi Kasei's Bionova Expands into Plasmid DNA for Cell and Gene Therapies
Japan headquartered chemicals group, Asahi Kasei, is expanding its Bionova CDMO’s services to include plasmid DNA (pDNA) production for cell and gene therapy developers by establishing a new facility in The Woodlands, Texas, where it is set to begin research-grade pDNA production in early 2025 and GMP manufacturing later that year. The move aims to leverage Texas' expanding cell and gene therapy ecosystem to help address growing demand for pDNA. The expansion comes as part of Asahi Kasei's broader strategy of enhancing its pharma business through CDMO capabilities.
The following article originally appeared in Fierce Pharma.
As Japanese chemical giant Asahi Kasei continues its foray into the biopharma contract manufacturing space, the company’s biologics CDMO is expanding its offerings to include starting materials for innovative medicines such as cell and gene therapies.
Asahi’s U.S. subsidiary Bionova Scientific is launching a new business line to provide services around plasmid DNA (pDNA), the companies announced Monday.
As part of the manufacturing pivot, Bionova is also setting up a new facility in The Woodlands, Texas, near Houston, where development work and research-grade pDNA production is scheduled to kick off in the first quarter of 2025, followed by GMP manufacturing later that same year.
Financial details around the new facility and production focus were not disclosed.
Plasmids—DNA molecules that exist in the cells of microorganisms like E. coli—are increasingly being used as starting materials for medicines like cell and gene therapies, mRNA vaccines and antibody drugs, according to Bionova. The company predicts the pDNA market will grow at double-digit rates over the next several years.
Bionova says it's charting the move thanks to "persistent unmet need" for high-quality, reliable pDNA supply among developers of new cell and gene therapies (CGT). The company is setting up shop in Texas in order to tap into the state's "rapidly expanding CGT ecosystem."
At present, Bionova has made a reputation for itself thanks to its work-in-process development of next-generation antibody-based drugs that are hard to produce. Asahi Kasei wrapped up its acquisition of Bionova back in April 2022, in turn adding CDMO capabilities to its existing bioprocess business.
In early 2023, Bionova said it planned to quadruple its existing GMP manufacturing capacity.
Meanwhile, Bionova’s new pDNA focus comes as its parent Asahi Kasei makes moves to expand its pharma business.
Just last week, the Japanese conglomerate made a cash offer to acquire Sweden’s Calliditas in a deal worth 11.16 billion Swedish crowns ($1.06 billion), which will allow Asahi to get its hands on the latter company’s primary immunoglobulin A nephropathy (IgAN) treatment Tarpeyo.
Asahi said it struck the deal in order to expand its business into immunology, transplantation and adjacent diseases, with particular emphasis on the U.S. market.
Asahi Kasei is one of Japan’s top industrial companies, with businesses across chemicals, electronics, pharmaceuticals, medical devices and more. The company established its U.S. pharmaceutical business back in 2020 with its acquisition of Veloxis Pharmaceuticals.
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