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  1. Project
8 July 2022

Bionova’s GMP Biologics Manufacturing Facility, Fremont, California

Bionova’s Fremont manufacturing facility produces clinical supply for clients using mammalian cell culture trains.
Bionova Scientific’s GMP biologics manufacturing facility in Fremont, California, was opened in October 2021. Credit: Bionova Scientific.
The facility is equipped with Cytiva’s FlexFactory bioprocess platform. Credit: Bionova Scientific.
The facility manufactures monoclonal antibodies and other recombinant proteins. Credit: Bionova Scientific.

Bionova Scientific has built a state-of-the-art biologics manufacturing facility at its headquarters in Fremont, California.

The good manufacturing practice (GMP) compliant facility is designed to improve the company’s service offerings for the biotherapeutics industry while helping it meet increasing demand for industrial biomanufacturing capacity. Bionova’s decision to build the biologics manufacturing facility was in response to demand from clients to meet their GMP production needs.

A ground-breaking ceremony for the GMP manufacturing centre took place in July 2020 and the facility was inaugurated in October 2021.

Location of Bionova’s Fremont manufacturing facility

The manufacturing centre is located within Bionova Scientific’s 56,000ft² (5,202.5m²) headquarters in Fremont, California, extending over an area of around 36,000ft² (3,344.5m²).

Bionova’s GMP manufacturing centre details

The plant is equipped with Cytiva’s FlexFactory bioprocess platform, which is designed to produce monoclonal antibodies and other recombinant proteins. A 1,000l Cytiva XDR upstream bioreactor train was initially installed at the facility and another 2,000l Cytiva system is expected to be added to the facility by the end of 2022 in line with increasing demand from customers.

The production facility uses single-use technology for all core unit activities to manufacture clinical and commercial bulk drug substances. It has added GMP manufacturing to Bionova’s existing portfolio of services, including cell line development, process development, GLP material production, process characterisation, and analytics.

The GMP centre was previously used as a cleanroom facility and has been reconfigured with the installation of plug-and-play equipment and systems.

The production facility uses single-use technology for all core unit activities.

Cytiva’s FlexFactory platform details

The FlexFactory bioprocessing platform uses single-use technology and includes distinct unit operations connected by single-use tubing sets. It provides the flexibility of installation in new or current workspaces and can include several automation schemes. It can be used to manufacture a range of biologics, including monoclonal antibodies (mAbs) or vaccines. The technology also allows for capacity to be scaled from pilot stage to commercial production.

FlexFactory platforms typically feature bioreactor systems, AKTA chromatography systems for protein purification operations, and Xcellerex XDUO and XDM Quad Mixing Systems for automation of the mixing of buffers, media and intermediates.

Funding for Bionova’s GMP manufacturing centre in Fremont

The expansion of Bionova’s operations was backed by a $22m equity commitment made by healthcare investment firm Great Point Partners (GPP) in June 2019.

The growth equity funding supported the company in the Fremont GMP facility’s construction.

Contractors involved in the project

For its Fremont facility, Bionova collaborated with DGA Architecture on design and architect services and Dome Construction on engineering and construction.

Marketing commentary on Bionova Scientific

Bionova Scientific is a contract development and manufacturing organisation (CDMO) that specialises in protein production, cell line development, process development, and analytical science.

Founded in 2014, the company has experience in terminal stage and commercial launch projects. It has worked with more than 200 customers in the biopharmaceutical industry to support them in their drug development efforts.

Bionova assists in the management of different stages of development and manufacturing of biologics, including initial research material development, process development, and contract manufacturing.

In March 2020, the firm announced that companies involved in the development of treatments for Covid-19 would be given priority access to its lab capacity.

In April 2022, Japanese medical device company Asahi Kasei Medical agreed to acquire Bionova through its American subsidiary. The acquisition will add a biopharmaceutical CDMO to Asahi’s bioprocess business.

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