Bionova Scientific Opens New Process Development and Pilot Plant in Fremont, California
Bionova Scientific, an Asahi Kasei company, has officially opened its new 55,000 sq. ft. process development and pilot plant in Fremont, California. The facility is designed to support the early-stage development of biologics assets and help accelerate their progression to first-in-human trials. Additionally, it will provide the company with expanded manufacturing capabilities to meet future demands as it grows. This expansion marks a significant step for the company as it continues to enhance its services for biopharmaceutical innovators.
Ribbon-Cutting Ceremony Marks the Milestone
To commemorate the opening of this new facility, it hosted a ribbon-cutting ceremony attended by around 150 industry and community leaders. Among those in attendance were key figures such as Darren Head, Chairman & President Jesse McCool, Ph.D., Chief Scientific Officer; and James Glover II, Chief Operating Officer. The event also had notable representatives from the City of Fremont, including The Honorable Raj Salwan, Mayor of Fremont, and staff from the offices of Congressman Ro Khanna, Congressman Eric Swallwell, State Senator Dr. Aisha Wahab, and the Alameda County Assessor Phong La.
Expanding Support for Early-Stage Biopharma Companies
The new plant is poised to significantly expand it’s ability to serve early-stage biopharma companies, which often require partners capable of providing agile process development and reliable manufacturing operations that are scalable. As Darren Head commented, many of Bionova’s clients are biopharmaceutical innovators who need flexible solutions that can evolve with the maturation of their programs. This new facility is designed to address that need, offering seamless technology transfer and scale-up capabilities from early-stage development through to first-in-human trials.
According to Darren Head, “This new facility enhances our capacity to serve early-stage clients while also providing overflow capacity for our larger biopharma customers.” This growth positions as a critical partner for businesses navigating the complex process of biologics development.
Fremont: A Hub for Biotech Innovation
Fremont, located in the heart of the San Francisco Bay Area, is a well-known hub for biopharmaceutical and medical device manufacturing. The city is home to more than 100 biomedical companies, earning it the title of “City Where BioMed Goes to Scale”. At the ceremony, Mayor Raj Salwan highlighted Fremont’s longstanding role as a leader in the biopharma industry. He stated, “Fremont has long been a leader in biopharmaceutical and medical device manufacturing. Having operated its entire existence in Fremont, it is unique in being a 100% homegrown success story, and their growth has been remarkable.”
Fremont’s thriving biotech sector is a key factor in the region’s dominance in biotech innovation, contributing more than $142 billion to the economy and providing over 328,000 jobs. As a local business, it’s expansion is not just a win for the company, but also for the community, which stands to benefit from the company’s growing influence in the biopharma sector.
Bionova’s Expanded Capabilities for Clients
Michelle Chen, Senior Vice President for Process Development and Manufacturing at Bionova, emphasized that the new facility brings all of it’s pre-GMP (Good Manufacturing Practice) activities under one roof. This integration allows Bionova to streamline the process and increase operational efficiencies, which will be particularly beneficial for their clients who are navigating the challenges of Chemistry, Manufacturing, and Controls (CMC).
“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. “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.”
The facility’s design and operational capacity enable Bionova to provide turnkey solutions for biologics development. This includes process optimization, pilot-scale production, and preparation for clinical trials. These enhanced capabilities allow the company to offer more flexible and responsive services, helping clients move their products efficiently from early-stage development to clinical and commercial stages.
Bionova’s Strategic Location in “Biotech Bay”
The San Francisco Bay Area, often referred to as “Biotech Bay”, is one of the most prominent regions in the world for biopharmaceutical development. The region accounts for a significant portion of U.S. biotech venture capital investment, making it an ideal location for companies like Bionova to partner with local innovators and bring biologics assets to market.
The opening of Bionova’s new facility in Fremont is a strategic move that positions the company at the heart of this vibrant biotech ecosystem, allowing it to serve not only local clients but also biopharma companies from across the U.S. and around the world. The new plant enhances Bionova’s ability to offer cost-effective and efficient solutions that help innovators move their biopharmaceutical assets toward clinical trials and, ultimately, to market.
Congressional Support for Bionova’s Expansion
The new facility was also welcomed by Congressman Ro Khanna (D-CA), who praised Bionova for its contributions to both the local economy and the biopharmaceutical sector. “Congratulations to Bionova Scientific on the opening of its new process development facility,” said Congressman Khanna. “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.”
Bionova’s expansion is seen as a testament to both the company’s growth and the region’s strength as a center for biotech innovation. The company’s ability to scale and provide comprehensive services aligns with the region’s increasing demand for advanced solutions in biopharmaceutical development.
Looking Ahead: Bionova’s Future Impact
With its new process development and pilot plant facility in Fremont, Bionova Scientific is positioned to play a pivotal role in the biopharmaceutical industry, particularly for companies looking to scale their innovations from early-stage development to clinical success. The plant’s capabilities will not only help local biotech companies thrive but will also contribute to advancing healthcare solutions on a global scale.
As Bionova continues to grow, its expanded capacity will enable it to support a broader range of clients, providing scalable solutions that meet the evolving needs of the rapidly changing biopharmaceutical landscape. With its deep expertise and cutting-edge facilities, Bionova is poised to remain a key player in helping biopharma innovators bring their products from concept to clinical reality.
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.
