New pDNA Facility in the Works for Bionova Scientific
The development and manufacturing plant will be constructed in Texas, and is expected to become operational by Q1 2025.
Bionova Scientific, a biologics contract development and manufacturing organization (CDMO) that was acquired by Asahi Kasei Medical,is dipping its toes into plasmid DNA (pDNA) production.1 This endeavor will be centered around a new development and manufacturing facility in The Woodlands, TX, which is close to Houston.
Once the plant becomes operational by Q1 2025, the CDMO is expecting to provide pDNA development services, alongside the production of research-grade and high quality pDNA. Good manufacturing practice (GMP) manufacturing is anticipated to launch later that same year.
As a result of customer demand—and in conjunction with a previously announced long-term strategic initiative by the company to expand its services portfolio to cover a extensive range of therapeutic modalities and technical capabilities—Bionova Scientific felt that it was time to dive into this particular space. According to the company, the pDNA initiative also comes in response to the“unmet need for high quality, timely, and reliable pDNA supply among developers of novel cell and gene therapies (CGT).”
There was even a strategy to the selection of The Woodlands as the location—it has a relativity close geographical proximity to CGT companies across the United States, all while the market in Texas continues to grow exponentially.
“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 COO. “We are confident that by this time next year, we will be well into thedelivery of expert development services and production of high quality pDNA.”
As previously announced last year, the company plans to grow its biologics production capacity at its Fremont, CA headquarters, which will quadruple GMP manufacturing capacity.
“Bionova’s mission has always been to help our partners gettheir therapeutics to patients faster,” noted Darren Head, Bionova Scientific’s CEO. “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.
“As we evaluated The Woodlands as a potential home for Bionova’s new pDNA operation,” Head continued, “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.”
Other Bionova executives also agree that the addition of pDNA to the mix offers access benefits for those in the therapeutics space.
“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 SVP of process development and manufacturing for pDNA.
Reference
1. Bionova Scientific announces plans for new Plasmid DNA GMP facility. Bionova Scientific. June 3, 2024. Accessed June 5, 2024. https://bionovascientific.com/news/pdna-facility/
