Cell culture technology centre
Bayer is building a cell culture technology centre in California for the development of biological therapies.
The facility will enable the company to bring innovative medicines to the market more quickly, as well as support Bayer’s plans to venture into cardiology, oncology and other therapeutic areas.
A ground-breaking ceremony for the $150m facility was held in May 2019, with construction scheduled to be completed by 2021.
Bayer’s new cell culture technology centre will be located within the company’s existing campus on 800 Dwight Way in Berkeley in California, US.
It is being developed on a 40,000ft² site, which was recovered from a demolished office building.
Bayer’s cell culture technology centre will be used to manufacture biologic therapies for different populations. It will systematise production by incorporating modern technologies such as automation, digitalisation and single-use bioprocessing technologies.
The new facility will include a GE Healthcare FlexFactory™ processing suite featuring Figurate automation, which is a digitally equipped platform used to improve and expedite biomanufacturing. The Figurate automation platform is expandable and can adapt to the needs of the customer, while minimising risks.
The FlexFactory™ processing suite will consist of two units of 2,000l single-use XDR™ bioreactors along with a purification train. It will also have the capacity to accommodate two more units of 2,000l single-use bioreactors and ancillary equipment.
GE’s FlexFactory™ is a single-use biomanufacturing platform that combines specific unit operations through single-use tubing sets. It has a greater manufacturing capacity compared to that of traditional methods, and can enable faster production of multiple doses for several customers.
The FlexFactory™ can process multiple products simultaneously and improve production by utilising adaptable processes. It features customisable tools and technical services to meet the user’s production process. Changeover time is reduced between batches, while the risks and costs associated with cleaning-in-place (CIP) are negated.
A FlexFactory™ can be operational within nine months, half the time required to set up a traditional laboratory capable of industrial-scale cell manufacturing.
As the main contractor, Fluor is responsible for the engineering, procurement, construction management and validation. The conceptual study and front-end engineering designing for the project began in 2018.
GE will supply its FlexFactory along with related equipment for the processing suite.
Bayer’s campus in Berkeley supports the company’s administration, production and research and development (R&D) activities. It is primarily used for manufacturing recombinant Factor VIII, which is used to develop haemophilia A treatments to be distributed across 80 countries.
The Berkeley site employs approximately 1,500 people and serves as Bayer’s headquarters for biotechnology product supply and drug development.
Bayer is a life science company with core businesses in the field of pharmaceuticals, healthcare and crop science.
The company generated €11.57bn ($13.11bn) in sales in North America in 2018. Apart from Berkeley, Bayer operates the US Innovation Center in San Francisco, which houses the first CoLaborator.
Bayer is establishing the cell culture technology centre to develop its resources as a result of its open innovation approach, which provides a platform to collaborate across all the units of the company. The new facility will support the development of the existing drug pipeline as well as new products.
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