Projects

Bionova’s New GMP Manufacturing Centre, Fremont

Project Type

New biologics manufacturing centre

Location

Fremont, California, US

Construction Started

July 2020

Expected Commissioning

Q3 2021

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Bionova Scientific is constructing its new state-of-the-art manufacturing facility in California, US, for the production of biologics.

The good manufacturing practices (GMP) compliant facility will improve the company’s service offerings to the biotherapeutics industry, while also supporting it to meet the increasing demand for industrial biomanufacturing capacity.

The ground-breaking ceremony of the GMP manufacturing centre took place in July 2020. The company is anticipated to complete the construction of the facility within ten months, starting operations in the third quarter of 2021.

Bionova is currently in talks with customers for production slots starting from 2021. The company’s move to build the biologics manufacturing facility was in response to demand from clients to meet their GMP production needs.

Location of Bionova’s new GMP manufacturing centre

The manufacturing centre is located within Bionova Scientific’s 56,000ft² headquarters in Fremont, California, extending across an area of approximately 36,000ft².

Bionova’s new GMP manufacturing centre details

The production facility will use single-use technology for all core unit activities. It will include two 2,000l mammalian cell culture trains (XDR bioreactor trains), which will manufacture clinical and commercial bulk drug substances.

It will add GMP manufacturing to Bionova’s existing portfolio of services including cell line development, process development, GLP material production, process characterisation and analytics.

The plant will be equipped with Cytiva’s FlexFactory bioprocess platform, designed to produce monoclonal antibodies and other recombinant proteins.

The GMP centre previously served as a cleanroom facility. The company is reconfiguring the facility and installing plug-and-play equipment and systems.

Cytiva’s FlexFactory

FlexFactory bioprocessing platform mainly 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 biologics including monoclonal antibodies (mAbs) or vaccines. The technology also allows scalability of capacity from pilot stage to commercial production.

A FlexFactory platform may usually have 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 new GMP manufacturing centre

“The production facility will use single-use technology for all core unit activities.”

Expansion of the company’s operations is backed by a $22m equity commitment made by health care investment firm Great Point Partners (GPP) in June 2019.

GPP provided $13.3m as of June 2019 and intends to fund a further $9m by 2021.

The growth equity funding is intended to support the construction of the Fremont GMP facility.

Contractors involved

Bionova collaborated with DGA for design and architect services and Dome Construction for 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, Bionova has experience in terminal stage and commercial launch projects.

The company worked with more than 200 customers in the biopharmaceutical industry to support them in their drug development efforts.

It 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, Bionova announced that companies involved in the development of treatments for Covid-19 would be provided priority access to its lab capacity.

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