The centerpiece of the project is a new development and manufacturing facility in The Woodlands, Texas – located near Houston.
When the new facility is operational in 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 to broaden its services portfolio to cover a wider range of technical capabilities and therapeutic modalities.
Specifically, the pDNA initiative is in response to the 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. This expansion is set to 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.”
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.”
Michelle Chen, Bionova’s senior vice president of process development and manufacturing for plasmid DNA, added: "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."