Bionova to Invest $100 Mn in Plasmid DNA Production

The expansion includes a new 100,000 sq ft development and manufacturing facility in The Woodlands, Texas, near Houston. 

US-based Bionova Scientific, an Asahi Kasei Group company, has announced a $100 million investment to expand its operations into plasmid DNA (pDNA) production. 

This move aligns with a long-term strategic initiative backed by the Asahi Kasei Group. The expansion includes a new 100,000 sq ft development and manufacturing facility in The Woodlands, Texas, near Houston. 

The facility is set to become operational in the first quarter of 2025, offering pDNA development services and producing research-grade and high-quality pDNA, with GMP manufacturing planned for early 2026.

Commenting on the initiative, James Glover, COO of Bionova, said, "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. 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’s Expansion Plans

The expansion comes as a response to the growing need for reliable and high-quality pDNA supply among developers of novel cell and gene therapies (CGT). 

According to Michelle Chen, senior VP of Process Development and Manufacturing for Plasmid DNA at Bionova, "By adding pDNA to our strategic offering, we are enhancing marketplace access to critical starting material across the landscape of clinical and commercial therapeutics."

Reportedly, after assessing various locations, Bionova selected The Woodlands for its strategic geographical proximity to CGT companies across the US and its access to Texas's expanding CGT ecosystem.

Sharing insights, Darren Head, CEO of Bionova Scientific, said, "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."

Future Prospects

The new facility in The Woodlands will play a crucial role in addressing the persistent unmet need for high-quality, timely, and reliable pDNA supply. 

This need is particularly pressing among developers of novel CGT. The facility's establishment is part of Bionova's broader effort to enhance its services portfolio and technical capabilities in response to diversifying customer requests.

With this expansion, Bionova aims to provide a more robust supply chain for CGT developers, ensuring that the high demand for pDNA does not hinder the progress of innovative therapies. 

The investment also signals Bionova's commitment to supporting the rapidly growing CGT field by offering essential materials and services that meet the highest standards of quality and reliability.

Founded in 2014, Bionova Scientific was acquired by the Asahi Kasei Group in 2022. The company is known for its high-quality biologics CDMO services. It's services are built on strong process development and analytical science.

Bionova's operations are optimized for multi-product manufacturing of monoclonal antibodies and other recombinant proteins, offering customized biomanufacturing services, cutting-edge process development expertise, and data-driven risk minimization strategies.