As a contract development and manufacturing organization (CDMO), FUJIFILM Diosynth Biotechnologies’ scientists and engineers need to offer flexible solutions to changing customer requirements. The increasing use of continuous methods in bioprocessing, for example, creates challenges for contractors where many more traditional process approaches dominate the conservative industry.
“Continuous biomanufacturing is a new area for biologics production, which has required cultural changes to the way the business approaches and considers manufacturing and its equipment compared to batch production,” said Charles Heise, senior staff scientist at the company. “As an example, equipment and process validation needs to consider fluctuating process perturbations as triggers for appropriate, characterized, and validated control measures rather than process deviations.”
FUJIFILM Diosynth Biotechnologies couldn’t source the modular equipment that it required to accommodate the demands of continuous processes. Heise added that the company needed equipment that “combined robust, durable single-use flow paths, standardized data acquisition, communication protocols, and advanced buffer management integrated with all downstream unit operations on a single skid.” Unable to find something that met all of those needs, the company chose to develop a proprietary skid called SymphonX™, which was able to operate all downstream bioprocessing steps in a semi-continuous manner.
This was an ambitious undertaking, pulling together multifunctional teams and leveraging corporate expertise to develop hardware capable of meeting crucial constraints. “The project has required a wide range of expertise to ensure adherence to regulatory requirements, including 21 CFR part 11 and GAMP 5 compliance, ICHQ guidelines, USP Class IV conformity, as well as meeting international safety standards and utilizing industry-accepted communication protocols,” Heise explained. “Ensuring compliance whilst maintaining the enduser’s need for a flexible and simple system challenged the innovation team.” Despite those challenges, the team has already developed and deployed the skid into GMP manufacturing suites. The next step is “to demonstrate operation of a non-GMP 500-L perfusion bioreactor connected to a continuously operating downstream purification process this summer,” Heise said.
The use of this skid will evolve with the market needs, and the ongoing pandemic drives many new demands. “Our latest challenge is COVID-19 restricting movement and standard work practices—giving the project the opportunity to test the remote working capabilities of SymphonX,” Heise said. The ability to work remotely is needed more than anyone could have imagined when his company started this project, and that need is not likely to change soon.