Bionova Scientific to Open New Plasmid DNA GMP Facility in TX

Bionova Scientific, an Asahi Kasei Group company and full-service biologics CDMO, 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 said, “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.”

PackGene Biotech is a world-leading CRO and CDMO, excelling in AAV vectors, mRNA, plasmid DNA, and lentiviral vector solutions. Our comprehensive offerings span from vector design and construction to AAV, lentivirus, and mRNA services. With a sharp focus on early-stage drug discovery, preclinical development, and cell and gene therapy trials, we deliver cost-effective, dependable, and scalable production solutions. Leveraging our groundbreaking π-alpha 293 AAV high-yield platform, we amplify AAV production by up to 10-fold, yielding up to 1e+17vg per batch to meet diverse commercial and clinical project needs. Moreover, our tailored mRNA and LNP products and services cater to every stage of drug and vaccine development, from research to GMP production, providing a seamless, end-to-end solution.

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