Bionova Scientific aims to quadruple GMP biologics manufacturing capacity

06-Feb-2023 - Last updated on 06-Feb-2023 at 12:19 GMT

The project is the first phase of a wider strategic initiative to expand capacity and enhance end-to-end biologics development and manufacturing services at the US CDMO.

Bionova Scientific has commenced commissioning of a third facility in Fremont, California, which it said will enable a significant scale-up of its manufacturing capacity and service capabilities.

The expansion, it said, also marks the start of a long-term strategic initiative by the company, which was founded in 2014, to broaden its services portfolio to cover an even wider range of technical capabilities and therapeutic modalities, in response to diversifying customer requests.

Acquired by the Asahi Kasei Group in 2022, Bionova Scientific is a full-service biologics contract development and manufacturing organization (CDMO). It says its operations are optimized for multi-product manufacturing of monoclonal antibodies and other recombinant proteins.

Manufacturing and development footprint

It currently operates two facilities in Fremont: a headquarters and development and GMP manufacturing facility on West Warren Avenue, and a nearby dedicated warehouse and storage facility on Fremont Boulevard.

The new Laurelview facility will act as a replacement headquarters and development center, housing Bionova Scientific’s administrative functions and biologics development teams that are currently located in the West Warren facility. In turn, the West Warren facility will become devoted to manufacturing operations, using advanced single-use equipment systems. The administrative offices and the labs for cell line development, process development and analytical services are expected to be moved to the Laurelview facility in mid-2023, ensuring the CDMO can quadruple its current biologics GMP manufacturing capacity in the West Warren facility shortly thereafter.

Darren Head, CEO of Bionova Scientific, said the cell line development, process development and analytical services teams will each have more capacity and resources for development projects, while increasing the GMP manufacturing footprint in the West Warren facility means the CDMO can provide more manufacturing slots to clinical and commercial customers to help them meet their timelines.