Fujifilm Diosynth Biotechnologies says it can overcome the burden of large buffer volumes associated with continuous purification as part of a new UK processing facility.
The facility in Billingham, UK will include a 500 L single-use perfusion bioreactor and 7 downstream processing units and is expected to begin offering process development later this year.
The plant represents a $10 million (€8.9 million) investment by the contract development and manufacturing organization (CDMO) and is the culmination of three years of in-house R&D by the Fujifilm group, resulting in a medium suitable for high density perfusion culture and the adoption of its Apollo X cell line platform for perfusion processing.
“This decision was made to expand the range of offerings that we provide to the industry,” Charles Heise, senior staff scientist from BioProcess Strategy & Development at Fujifilm Diosynth Biotechnologies, told Bioprocess Insider.
The new continuous manufacturing offering is suited to labile, unstable products, he continued, adding “continuous manufacturing improves quality metrics as the process is expected to be on a steady state of equilibrium.
“Products that are subject to scale-up issues will also benefit from continuous manufacturing. Continuous will have an impact on biologics that follow the high volume/low value model.”
The plant is expected to yield more than 15 kg of antibody from a single four week batch at 500 L scale.
Continuous production of biologics should deliver a COGS reduction, but for end-to-end continuous manufacturing, the adoption of perfusion in the upstream has been stifled by limitations in the downstream.
“Identified solutions are to increase size of facility to accommodate for additional buffer production capacity – an undesirable path – or use buffer stock concentrates,” said Heise. “Fujifilm Diosynth Biotechnologies has created a downstream processing skid with an on-board in-line buffer management system to elegantly address this bottleneck in an innovative manner.”
This includes a multi-functional system for downstream purification the firm says is able to deliver 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 paths.