USA – Bionova Scientific, a biologics contract development and manufacturing organization (CDMO) with extensive protein production, cell line development, process development, and analytical expertise, has opened a commercial-ready fully single-use GMP biologics manufacturing center at its headquarters in Fremont, CA.
The GMP-compliant facility will enhance the company’s service offerings to the biotherapeutics industry while also assisting it in meeting the growing demand for industrial biomanufacturing capacity.
The first clinical supply run at the cutting-edge facility will be completed by the end of 2021.
Bionova was able to overcome logistical and supply-chain challenges to complete construction on time and on budget in less than 12 months after announcing the project in July 2021 amid the disruption of the COVID-19 pandemic.
The biomanufacturing site will have two 2,000-liter mammalian cell culture trains and the ability to produce multiple monoclonal antibodies and other recombinant proteins at the same time, which is one of the CDMO’s areas of expertise.
DGA Architecture designed the facility, which was built by Dome Construction. The facility will initially operate one 1000-liter Cytiva XDR upstream train.
In third-quarter of 2022, a 2000-liter Cytiva system will be added, with a second 2000-liter system following as client demand dictates.
The facility was designed to comply with international commercial drug manufacturing regulations.
“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,” said Darren Head, CEO, Bionova.
“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.”
Fremont Mayor Lilly Mei delivered the keynote address and awarded Bionova with a certificate of appreciation for its contributions to the community.
“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,” Bionova co-founder and chief technical officer, Chung Chun, said.
Meanwhile, other pharmaceutical companies have ramped up their own biologics operations. For example, in June, Fujifilm invested US$928 million in a former Biogen biologics facility in Denmark that it had acquired a year before.
Fujifilm believes that the cash infusion will eventually increase revenue for its bio-CDMO business to US$928 million per year.