Fujifilm Corporation has announced an initial $10-million investment in a full-scale, fully integrated continuous processing facility for non-GMP manufacturing of biopharmaceuticals at the Billingham, UK site of Fujifilm Diosynth Biotechnologies, the company’s contract biologics manufacturing arm.  

The perfusing-based facility includes the introduction of patented, downstream bioprocessing technology. Perfusion is a cell-culture manufacturing process that involves the constant feeding of fresh media and processing of harvested media over several weeks. Fujifilm’s upstream perfusion process utilizes a proprietary process control system with automatic feedback control for cell density and nutrient addition to maintain steady-state conditions.

Fujifilm notes that the adoption of perfusion processing by the biopharmaceutical industry has been hindered somewhat by an inability to continuously purify the culture downstream due to equipment limitations and the large buffer volumes involved. The company has developed and patented a multi-functional system for downstream purification to deliver required unit operations, including chromatography, ultra and dia-filtration (UFDF), single pass tangential flow (SP-TFF), viral inactivation and filtration and point of use in-line preparation of buffers within common single-use flow paths. This technology can be deployed in both batch and continuous processing environments.

The new facility will include a 500-L single-use perfusion bioreactor and seven patented downstream processing units expected to yield more than 15 kg of antibody from a single four-week batch at 500-L scale.

The new system will be available for process development services in the fall of 2019.

Source: Fujifilm