Fremont, CA October 26, 2021 – Bionova Scientific, a biologics CDMO with extensive protein production, cell line development, process development and analytical expertise, today announced the grand opening of its commercial-ready fully single-use GMP biologics manufacturing center at its Fremont, California headquarters. The first clinical supply run at the state-of-the-art facility will be completed before year-end 2021.
After announcing the project in July 2021 amid the disruption of the COVID-19 pandemic, Bionova was able to overcome logistical and supply-chain challenges to complete construction on-time and on-budget in less than 12 months. The facility was designed by DGA Architecture and built by Dome Construction. At launch, the facility will operate one 1000 liter Cytiva XDR upstream train. A 2000 liter Cytiva system will be added in Q3/2022 with a second 2000 liter system to follow as client demand dictates. The facility was engineered to meet global commercial drug manufacturing regulations.
Bionova Chief Executive Officer, Darren Head, commented, “After more than 18 months of planning, design and construction, we could not be more proud of the finished product created by this great team. Bionova’s experience in creating and operating best-in-class biologics facilities combined with the know-how of DGA, Dome and critical equipment vendors resulted in a GMP manufacturing facility that is second-to-none. The fact that is was completed on-time despite the countless challenges of the past year is a testament to the commitment and creativity of our entire organization.”
Head added, “This event is also a great opportunity to honor our founders, Amy Kong and Chung Chun. Thanks to their vision and the team they built, Bionova has become a trusted resource to some of the top biopharmaceutical innovators. This facility enables us to help take those clients and their products across the finish line.”
The grand opening event was attended by nearly 100 Bionova clients, vendors, industry leaders and government officials. Fremont Mayor Lilly Mei provided a keynote address and presented Bionova with a certificate of appreciation in recognition of Bionova’s contributions to the community.
Bionova co-Founder and Chief Technical Officer Chung Chun added, “It is truly humbling to see this beautiful facility after the tremendous work done by our team over the past year. Everyone who visited today was absolutely awed. We are grateful to the clients who have expressed such trust in our team and we are energized to start our first clinical production run next month.”
BOUT BIONOVA SCIENTIFIC
Founded in 2014, Bionova offers world-class biologics CDMO services built on a foundation of strong process development and analytical science with a staff that brings decades of experience in late stage and commercial launch projects. We firmly believe that a robust, well-understood process and well-characterized molecule are critical cornerstones of your molecule’s success. Our upstream PD group, with more than 60 benchtop bioreactors, offers a breadth and depth of capability typically found at only the largest CDMO’s. Bionova takes an expansive view at solving client process problems. In 2021, Bionova opened a, 11,000 sq. ft. GMP biologics manufacturing facility to provide clinical and commercial production for clients. The fully single-use facility is located within Bionova’s 57,000 sq. ft. headquarters, adjacent to existing process development and analytical laboratories, and is optimized for multi-product manufacturing of monoclonal antibodies and other recombinant proteins.