Having heard the demand from customers to add GMP biomanufacturing, Bionova has begun construction of a facility in Fremont boasting two 2,000 L single-use trains.

Bionova Scientific has started to cement the ‘M’ in CDMO (contract development and manufacturing organization) after it broke ground on a 36,000 square-foot production facility last week at its site in Fremont, California.

According to the firm, the “well-documented need for high-quality manufacturing capacity in the industry” helped drive the expansion, as did the call from customers to stick with Bionova as a project enters the next stages of the development process.

Image: iStock/Anna Fomenko

“After having a great experience with us on a development project, they have been disappointed in the past when having to turn elsewhere for GMP production,” the CDMO told this publication.

“They want to see their clinical and commercial production needs handled by the same team that has been doing such a great job in other aspects of the development program.  We are happy that we will now be able to see these programs through to completion.”

Currently Bionova offers services including cell line development, GLP material production, process development, process characterization, and analytics. The new facility will add GMP manufacturing using FlexFactory from Cytiva, incorporating two single-use XDR 2,000 L bioreactor trains.

Construction is expected to be completed within 10 months, with commissioning scheduled for Q3 2021. According to the firm, a number of factors contributed to such ambitious timelines.

“For several months, we have been working closely with DGA (architect and design) and Dome Construction (engineering and construction), each of whom specializes in GMP facility projects and brings great practical knowledge to this project.

“Our own team members, including our Board, have been down this road before in their previous roles, and additionally, our clients have provided great guidance in our planning.”

The company added: “Our new GMP facility was previously used for electronics clean room operations, so while there is much reconfiguring to do, we are starting with a solid space.   Much of the time-efficiency comes from the use of plug-and-play equipment and systems such as FlexFactory from Cytiva, an extremely well-coordinated and focused project team, and great cooperation from vendors and contractors.”

Investment and jobs

The size of the investment has not been divulged, but the firm said the expansion has been instigated by a $22 million equity commitment from Great Point Partners announced last year.

The expansion will also create over 50 jobs in operations and supporting functions to support the GMP production activities.

“We’re fortunate that our current team has deep ties in the Bay Area biomanufacturing community, so we are regularly being sought out by highly talented and experienced specialists looking to work in a technically elevated yet entrepreneurial environment.”