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Fujifilm Diosynth To Expand Bio-Capabilities

Will boost cGMP mammalian cell culture at Billingham

By: Gil Roth

President, Pharma & Biopharma Outsourcing Association

Fujifilm Diosynth Biotechnologies will expand its services in mammalian cell line development/process development, and add a multi-product cGMP facility at its Billingham, UK site.

The first phase has seen development of the company’s cell line and process/analytical development facilities, including addition of the latest high throughput technologies to enable rapid transition of biologics from discovery to clinic. This is supported by a significant increase of the Mammalian Development Group to create a dedicated expert pool of scientists for both new technology development and delivery of customer programs.

Work has also begun on a cGMP Cell Bank and 1000L biologics manufacturing facility at the Billingham site. This facility will be based upon single-use technology for both upstream and downstream operations, offering flexible, integrated solutions and speed to clinic, according to a company statement.

Steve Bagshaw, managing director, Fujifilm Diosynth Biotechnologies UK business, said, “This expansion will build upon our leadership position in microbial-based biopharmaceuticals, reinforcing Fujifilm’s commitment to lead the global biologics CMO industry through continuous innovation and implementation of new technologies. This European facility, together with our new cell line development and expanded process development capability, complements our U.S. operation and will provide our customers with a full life-cycle offering, from gene to GMP, for preclinical studies, early phase to mid-phase clinical production and beyond.”

The company announced the addition of a 1,000L single-use bioreactor at its Research Triangle Park, NC facility in May 2011, supplementing its existing 2,000L stainless steel train at the cGMP manufacturing plant. The new Cell Bank manufacturing facility in Billingham will be available in 2Q13 and the mammalian cell culture biologics manufacturing facility is expected to be validated and fully operational in the second half of 2013.

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