Bionova to quadruple Fremont plant biologics capacity

Bionova Scientific has commissioned a third CDMO facility in Fremont, California, freeing space to quadruple manufacturing capacity at its nearby plant.

Bionova, which fully transitioned into a contract development and manufacturing organization (CDMO) in November 2021, and was later acquired by Asahi Kasei Medical in April 2022, is set to begin the first phase of its strategic expansion.

The firm already operates from two facilities in Fremont. One of the plants acts as its headquarters and the other is a development and manufacturing facility located on West Warren Avenue. The third facility, of which financial details have not been disclosed, is on Laurelview Court and will be a replacement headquarters and development center, as well as housing the CDMO’s administrative and biologics team that currently work out of its West Warren facility.

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The West Warren facility will then be dedicated to manufacturing operations and will make use of single-use equipment systems. The Laurelview plant is expected to include labs for cell line development, process development and analytical services in mid-2023. The transition of operations means Bionova can quadruple its current biologics manufacturing capacity in the West Warren facility shortly after the move has taken place.

“The West Warren facility will house multiple 2,000 L GMP manufacturing trains for clinical and commercial GMP manufacturing of monoclonal antibody, bispecific antibody, nanobody, fusion protein and other recombinant protein products,” Amy Driver, vice president of business development at Bionova, told BioProcess Insider.

“Laurelview will house cell Line development, process development and analytical services technical groups as well as our corporate offices. We are also expanding our lease in the Fremont storage facility to occupy the entire facility, [tripling] pallet positions and an expanded freezer farm.”

As the extra capacity comes online, Driver said the CDMO will “significantly increase” its headcount.

“The manufacturing expansion will require staff for the multiple new 2,000 L manufacturing trains. In addition to our expanded manufacturing footprint, we will be adding staff to our cell line development and process development groups which are our foundational core strength.”

“Those groups have been critical in developing products for multiple clients who came to us with an idea and are now in the clinic, some of whom have been acquired by larger pharma companies for continued development and commercialization.”