The centerpiece of the project is a new 100,000 square foot development and manufacturing facility in The Woodlands, Texas. The new facility is expected to start operation in the first quarter of 2025 and will offer pDNA development services and production of research grade and high quality pDNA. GMP manufacturing is planned for early 2026, the company said.

The expansion is part of a previously announced long-term strategic initiative by the company to broaden its services portfolio. 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), Bionova said. According to Bionova, it selected The Woodlands location due to its geographical proximity to CGT companies across the US, 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.”

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