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The $10-million investment will include a 500-L single-use perfusion bioreactor and seven patented downstream processing units.
On June 5, 2019, FUJIFILM Diosynth Biotechnologies announced a $10-million investment to establish a full-scale, fully integrated continuous processing facility for non-GMP biopharmaceutical manufacturing at its Billingham, UK, location.
The new facility will include a 500-L single-use perfusion bioreactor and seven patented downstream processing units that are expected to yield >15kg of antibody from a single four-week batch at 500-L scale, according to the company. The new system will be available for process development services in fall 2019.
The company’s upstream perfusion process uses a proprietary process control system with automatic feedback control for cell density and nutrient addition to maintain steady state conditions. Fujifilm has developed an in-house, defined medium suitable for high-density perfusion culture and has adapted its ApolloX cell line for perfusion processing. This system, an alternative to traditional fed-batch cell-culture processes, offers reduced degradation and aggregation.
The company reports that adoption of perfusion processing by the biopharmaceutical industry has been hindered somewhat by an inability to continuously purify the culture downstream because of equipment limitations and the large buffer volumes involved. FUJIFILM states that it has dedicated significant scientific and engineering resource to address this challenge.
Fujifilm has also developed and patented a multi-functional system for downstream purification and is able to deliver all required unit operations, including chromatography, ultra and dia-filtration, single pass tangential flow, viral inactivation and filtration, and point of use in-line preparation of buffers within a common single-use flow paths. This technology can be deployed in both batch and continuous processing environments.