Fujifilm Diosynth Biotechnologies will locate the facility in Billingham, UK, which will feature proprietary process controls that provide automatic feedback control for cell density and nutrient addition.
The perfusion facility will involve the constant supply of fresh media and processing of harvested media over a period of weeks. In addition, the company noted that it has designed ‘disruptive’ downstream bioprocessing technology for the facility.
Andy Topping, CSO of Fujifilm Diosynth Biotechnologies, explained to BioPharma-Reporter how this technology would achieve this.
Topping said, “One of the challenges with using commercially available equipment from a number of vendors has been the difficultly in connecting the pieces of equipment together, plus the challenges with ensuring that operators are familiar with multiple pieces of hardware and software interfaces. In addition, a continuous process requires all unit operations to be running simultaneously, which causes huge buffer demands.
“We have developed a single piece of equipment which is able to operate each of the required process steps and can be linked together to run the full process plus mix buffers from concentrated stocks at the point of use.”
What this means in practice is that the unit’s operations can include chromatography, ultra and dia-filtration, single pass tangential flow, viral inactivation and filtration and point of use in-line preparation buffers within a common single-use flow pathway.
The facility will include a 500L single-use perfusion bioreactor and seven downstream processing units. It is expected to yield greater than 15kg of antibody from a four-week batch at 500L scale.
When asked about the advantages of the single-use system, Topping outlined, “Building a continuous system in stainless steel is possible currently but gives a fixed process flow. The use of individual systems that can be connected and reconfigured to a variety of process flows is much more useful, particularly for clinical supply when the commercial process may not be finalised.”
“Fully single-use systems ensure rapid changeover and reconfiguration without issues of cleaning validation, verification or potential product carryover,” he emphasised.
According to the company, the continuous system offers a cost-effective alternative to traditional fed batch cell cultures processes and its process mitigates some of the challenges previously met in purifying the culture downstream.
“Continuous production is inherently more efficient as it reduces downtime required to clean and restart equipment. In the real world, this equates to being able to reduce the size of equipment required or produce more product from established facilities,” Topping told us.
He added that the steady state of the continuous process also produces a higher level of product quality compared to batch production.
Fujifilm Diosynth Biotechnologies will make the system available for non-good manufacturing practice (GMP) process development services in autumn of 2019.