Bionova Opens Fremont Process Development and Pilot Plant

FREMONT, Calif.--(BUSINESS WIRE)-- Bionova Scientific, an Asahi Kasei company and boutique commercial-scale biologics contract development and manufacturing organization (CDMO), has announced the opening of 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.

Bionova leadership team celebrates ribbon cutting at new Fremont, CA Process Development & Pilot Plant facility with community leaders. (Photo: Business Wire)

Bionova hosted a ribbon-cutting ceremony attended by approximately 150 industry and community leaders to mark the occasion. Darren Head, Chairman & President; Jesse McCool, Ph.D., Chief Scientific Officer; and James Glover II, Chief Operating Officer, were joined by The Honorable Raj Salwan, Mayor of the City of Fremont. Representatives were also in attendance from the Office of Congressman Ro Khanna and Congressman Eric Swallwell; the Office of State Senator Dr. Aisha Wahab; the Office of the Alameda County Assessor Phong La; and Cindy Bonior, CEO of the Fremont Chamber of Commerce.

“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 scaleable, 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.”

At the event, Fremont Mayor Raj Salwan commented, “Fremont has long been a leader in biopharmaceutical and medical device manufacturing. Being home to over 100 biomedical companies, Fremont has adopted the industry slogan of being the City where BioMed goes to scale. Having operated its entire existence in Fremont, Bionova is unique in being a 100% homegrown success story, and their growth has been remarkable. Fremont wholeheartedly congratulates Bionova on their new facility and expansion in our community and looks forward to our continued partnership for many years to come.”

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,” said Michelle Chen, Senior Vice President 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.”

Congressman Ro Khanna (D-CA) commented, “Congratulations to Bionova Scientific on the opening of its new process development facility. Bionova is a native son of my hometown of Fremont and is now positioned to help biopharma drug makers move their innovations from early-stage compounds to commercial, life-saving drugs, including potential new cancer treatments.”

To learn more about Bionova, visit https://bionovascientific.com/

About Bionova Scientific

Bionova Scientific partners with innovators in the biologic industry to bring life-changing therapies to market. Founded in 2014 and acquired by Asahi Kasei Group in 2022, Bionova Scientific offers customers access to superior tools and technologies and an unwavering commitment to quality delivered with scientific excellence across the entire lifecycle. Bionova offers integrated CDMO services that span cell line development, process development to the cGMP manufacturing of complex proteins and antibodies. Our experienced Bay Area scientists bring proven expertise to overcoming discovery to first-in-human development challenges and scale-up. Bionova is a flexible and collaborative partner that has worked with leading biotechnology innovators from its new state-of-the-art facility in the San Francisco Bay Area.

About Asahi Kasei

The Asahi Kasei Group contributes to life and living for people around the world. Since its foundation in 1922 with ammonia and cellulose fiber businesses, Asahi Kasei has consistently grown through the proactive transformation of its business portfolio to meet the evolving needs of every age. With more than 49,000 employees worldwide, the company contributes to a sustainable society by providing solutions to the world’s challenges through its three business sectors of Material, Homes, and Health Care. Its health care operations include devices and systems for acute critical care, dialysis, therapeutic apheresis, and manufacture of biotherapeutics, as well as pharmaceuticals and diagnostic reagents. For more information, visit asahi-kasei.com and ak-bio.com.

View source version on businesswire.com: https://www.businesswire.com/news/home/20250304031091/en/

Bionova Scientific:

Chris Halling (Orientation Marketing)

+44 (0)7580 041073

Chris.Halling@orientation.agency



Asahi Kasei North America:

Asahi Kasei America Inc.

Christian Okeefe

Christian.okeefe@ak-america.com



Asahi Kasei Europe:

Asahi Kasei Europe GmbH

Sebastian Schmidt

sebastian.schmidt@asahi-kasei.eu

Source: Asahi Kasei

FAQ

What is the size and purpose of Bionova's new Fremont facility?

The new 55,000 sq. ft. facility serves as a process development and pilot plant, designed to advance early-stage biologics to first-in-human trials and expand manufacturing capacity.

How does the new facility benefit AHKSY's Bionova operations?

The facility consolidates all pre-GMP activities under one roof, enabling seamless technology transfer, improved efficiency, and enhanced capacity to serve both early-stage and large biopharma clients.

What is the economic impact of the Biotech Bay region where AHKSY's new facility is located?

The San Francisco Bay Area's biopharma industry generates over $142 billion in economic activity and provides more than 328,000 direct and indirect jobs.

How many industry and community leaders attended AHKSY's Bionova facility opening?

Approximately 150 industry and community leaders attended the ribbon-cutting ceremony, including local government officials and business representatives.