FUJIFILM Biotechnologies has unveiled ShunzymeX, a purification technology designed to simplify downstream processing for complex biologics.

The contract development and manufacturing organisation said the platform aims to streamline process development and help developers move more quickly toward GMP manufacturing. The technology will be presented at the Festival of Biologics conference in San Diego.

ShunzymeX was developed in collaboration with the University of Edinburgh and uses a proprietary protease designed to support purification of complex biologic proteins using a simplified workflow.

The technology allows an affinity tag to be added to a protein of interest, enabling purification using a standard affinity resin. Once purification is complete, the protease removes the tag without leaving changes on the native protein.

Downstream purification of microbial-expressed proteins can be difficult because of the diversity in protein size and sequence. This variability often limits the availability of suitable affinity resins and can complicate purification strategies.

Without a reliable affinity chromatography step, developers may rely on more complex purification workflows that increase development timelines and can reduce yields or purity. FUJIFILM Biotechnologies said the new technology aims to address these challenges by enabling a consistent purification step across different microbial proteins.

The company also said the system can be used with multiple expression systems and is designed to scale directly to cGMP manufacturing. By simplifying purification, the platform may help shorten process development timelines and support faster progression toward investigational new drug enabling milestones.

John Stewart, senior vice president of global process development at FUJIFILM Biotechnologies, said the company’s experience in microbial technologies supported the development of the new platform.

“FUJIFILM Biotechnologies has more than 30 years of experience in microbial innovations, exemplified with our Paveway expression system, coupled with a proven track record in process development and a history of advancing microbial technologies,” Stewart said: “Together, we believe this innovation will help create a faster path for our customers to commercialization.”

The company will introduce the technology during the Festival of Biologics, a conference focused on biologics development and manufacturing. The event brings together researchers, manufacturers and technology providers to discuss advances in biologic medicines.

Kenneth Holbourn, senior director technical project leader group at FUJIFILM Biotechnologies, said the conference provided an opportunity to present the technology to industry specialists.

“We’re excited to introduce ShunzymeX at the Festival of Biologics, an event with more than 2,000 attendees exploring the latest technologies and discoveries advancing our industry,” Holbourn said: “With a strong spirit of innovation at this event, it is the perfect forum to showcase how ShunzymeX can help streamline purification for microbial products.”

FUJIFILM Biotechnologies said ShunzymeX can also be used alongside its SymphonX downstream processing platform, an automated system designed to run multiple downstream unit operations within a single equipment setup.

The technology was developed through a collaboration between FUJIFILM Biotechnologies and the University of Edinburgh that began in 2019. The partnership received joint funding from UK Research and Innovation and support from Edinburgh Innovations, the university’s commercialisation service.

Susan Rosser, academic lead for the collaboration at the University of Edinburgh, said the partnership helped translate academic research into industrial application.

“It’s fantastic to see the ShunzymeX technology, co-developed by my colleague Professor Emerita Lynne Regan and our longstanding collaborator, FUJIFILM Biotechnologies, out in the world.

“This kind of transformative partnership unlocks the power of new technologies we have developed and applies them to key industry challenges, ultimately making treatments and vaccines easier to manufacture and more accessible to millions of people.”