Bionova Scientific, an Asahi Kasei company and boutique commercial-scale biologics contract development and manufacturing organization (CDMO), has opened a new facility in Fremont, California.

The 55,000 sq. ft. process development and pilot plant will significantly expand the company’s ability to advance early-stage biologics assets to first-in-human trials and facilitate the future expansion of its manufacturing capacity.

“Many of our customers are early-stage biopharmaceutical innovators who need agile partners who can quickly provide process development and reliable manufacturing operations that are scalable, without the need to tech transfer to another CDMO as their programs mature,” commented Darren Head, Chairman & President of Bionova. “This new facility enhances our capacity to serve early-stage clients while also providing overflow capacity for our larger biopharma customers.”

Widely known as “Biotech Bay,” the biopharma industry in the San Francisco Bay Area is considered one of the largest in the United States, generating more than $142 billion in economic activity and over 328,000 direct and indirect jobs. The region represents a substantial portion of U.S. biotech venture capital investment, positioning Bionova to help local innovators advance their assets to the clinic efficiently and cost-effectively.

“Bionova’s team of bioprocess experts has proven itself as a valuable partner for clients seeking to overcome challenging CMC issues, especially with complex modalities,” added Michelle Chen, SVP for Process Development and Manufacturing at Bionova. “With this new facility, all of our pre-GMP activities are co-located and integrated under one roof. We already see meaningful technical and efficiency gains as our PD teams can facilitate seamless technology transfer by scaling and training simultaneously.”

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Bionova is also expanding with a new development and manufacturing facility in The Woodlands, Texas, which is planned to open later in 2025.