Fujifilm made an initial $10 million investment to establish a full-scale, fully-integrated continuous processing facility for non-GMP manufacture of biopharmaceuticals at Fujifilm Diosynth Biotechnologies in Billingham, U.K., location.
Fujifilm officials say their advanced upstream perfusion process utilizes a proprietary process control system with automatic feedback control for cell density and nutrient addition to maintain steady-state conditions. The company also has developed an in-house, defined medium suitable for high-density perfusion culture and has adapted its Apollo™ X cell line for perfusion processing, they added.
According to Fujifilm, a patented multi-functional system for downstream purification will be available and able to deliver all 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 a common single-use flow path. This technology reportedly 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 that are expected to yield >15kg of antibody from a single four-week batch at 500 L scale, noted the company. The system will be available for process development services in Fall 2019.