Bionova Scientific announces plans for new Plasmid DNA GMP facility

Facility in The Woodlands, Texas to produce critical starting material for cell and gene therapy, DNA/RNA-based, and recombinant protein therapeutics in Q1/2025

Fremont, CA   June 3, 2024 – Bionova Scientific, an Asahi Kasei Group company and full-service biologics CDMO, announced plans to expand into plasmid DNA (pDNA) production. The centerpiece of the project is a new development and manufacturing facility in The Woodlands, Texas (near Houston). When the new facility begins operation (planned for Q1/2025), Bionova Scientific will offer pDNA development services and production of research grade and high quality pDNA. GMP manufacturing is planned for later in 2025.

The expansion is part of a previously announced long-term strategic initiative by the company – supported by the Asahi Kasei Group – to broaden its services portfolio to cover an even wider range of technical capabilities and therapeutic modalities, in response to diversifying customer requests. Specifically, the pDNA initiative is in response to the persistent unmet need for high quality, timely, and reliable pDNA supply among developers of novel cell and gene therapies (CGT). After evaluating multiple locations, Bionova selected The Woodlands due to its geographical proximity to CGT companies across the United States, as well as local access to the rapidly expanding CGT ecosystem in Texas.

“For the past few years, we’ve seen the cell and gene therapy marketplace struggle with constrained availability of high quality pDNA. In response, we have been building internal expertise and creating a thoughtful market entry plan, culminating with today’s announcement of our new Houston facility,” said James Glover, Bionova’s Chief Operating Officer. “We are confident that by this time next year, we will be well into the delivery of expert development services and production of high quality pDNA.”

Bionova Scientific is also currently expanding biologics production capacity at its Fremont, California headquarters, as announced in early 2023. That expansion will quadruple GMP manufacturing capacity and position the company for manufacture of commercial biotherapeutics.

Darren Head, CEO of Bionova Scientific commented, “Bionova’s mission has always been to help our partners get their therapeutics to patients faster. In our traditional biologics operation, we’ve had great success helping partners overcome technical hurdles and streamlining timelines to get them into the clinic rapidly. That requires that we not only work smarter, but that we have the physical assets needed to avoid delays. We are taking the same approach with plasmid DNA, starting with building a committed, expert team and then designing and establishing a facility that will translate to the same kinds of successes.”

Bionova Headquarters - Fremont , CA

Shown is the Research Forest in The Woodlands, Texas, the planned future site of Bionova’s pDNA facility. (Photo courtesy of Warmack Investments.)

Head also acknowledged the support of several local organizations in the lead-up to Bionova’s decision: “As we evaluated The Woodlands as a potential home for Bionova’s new pDNA operation, the enthusiastic support of The Montgomery County Commissioners, The Woodlands Township and The Woodlands Area Economic Development Partnership was instrumental. We appreciate their welcoming help and look forward to a continued collaboration as we proceed forward.”

“Bionova is driven to support our partners to bring life-saving treatments to patients. By adding pDNA to our strategic offering, we are enhancing marketplace access to critical starting material across the landscape of clinical and commercial therapeutics,” added Michelle Chen, Bionova’s Senior Vice President of Process Development and Manufacturing for Plasmid DNA.


About Bionova Scientific
Founded in 2014 and acquired by the Asahi Kasei Group in 2022, Bionova Scientific offers world-class biologics CDMO services built on a foundation of strong process development and analytical science with a staff that brings decades of experience in late stage and commercial launch projects. With its high quality, customized biomanufacturing services, cutting-edge process development expertise and data-driven risk minimization strategies, the company is renowned for helping client projects move quickly from concept to robust GMP production. Bionova Scientific’s operations are optimized for multi-product manufacturing of monoclonal antibodies and other recombinant proteins.

About Asahi Kasei
The Asahi Kasei Group contributes to life and living for people around the world. Since its foundation in 1922 with ammonia and cellulose fiber businesses, Asahi Kasei has consistently grown through the proactive transformation of its business portfolio to meet the evolving needs of every age. With more than 48,000 employees worldwide, the company contributes to a sustainable society by providing solutions to the world’s challenges through its three business sectors of Material, Homes, and Health Care. Its health care operations include devices and systems for acute critical care, dialysis, therapeutic apheresis, and manufacture of biotherapeutics, as well as pharmaceuticals and diagnostic reagents. For more information, visit asahi-kasei.com and ak-bio.com.

Please submit any questions regarding this news item using the form below…