FUJIFILM Biotechnologies Launches ShunzymeX Precision Purification Technology

Developed in collaboration with the University of Edinburgh, ShunzymeX uses a proprietary protease to enable streamlined purification of microbial-expressed biologics.

FUJIFILM Biotechnologies has unveiled ShunzymeX, a precision purification technology aimed at simplifying downstream processing for complex biologics and accelerating readiness for GMP manufacturing. The company is presenting the technology this week at the Festival of Biologics in San Diego.

Developed in collaboration with the University of Edinburgh, ShunzymeX uses a proprietary protease to enable streamlined purification of microbial-expressed biologics. The platform allows the addition of an affinity tag to a target protein, enabling purification using an off-the-shelf affinity resin. After purification, the protease cleaves the tag without leaving residual sequences on the native protein.

According to the company, the technology addresses longstanding challenges in microbial downstream purification. Variability in protein size and sequence often limits the availability of suitable affinity resins, resulting in extended development timelines, lower yields, and reduced purity when traditional methods are used. By introducing a standardized affinity step, ShunzymeX is designed to shorten process development timelines and support faster progression toward investigational new drug (IND)-enabling milestones and GMP manufacturing.

The company stated that the platform is compatible with multiple expression systems and is scalable directly to cGMP production.

John Stewart, senior vice president of Global Process Development at FUJIFILM Biotechnologies, said the technology builds on the company’s three decades of experience in microbial innovation and process development. “Together, we believe this innovation will help create a faster path for our customers to commercialization,” he said.

Kenneth Holbourn, senior director and technical project leader group at the company, will present the technology in a session titled “Accelerating and Streamlining Microbial Process Development with a Novel Technology” on March 4 at 2:50 p.m. PT during the conference.

The partnership between FUJIFILM Biotechnologies and the University of Edinburgh began in 2019 with joint funding from UK Research and Innovation and support from Edinburgh Innovations. Professor Susan Rosser, academic lead for the collaboration, said the co-developed technology demonstrates how academic-industry partnerships can address manufacturing challenges in biologics and vaccine development.

ShunzymeX can also be paired with SymphonX™, the company’s automated downstream processing platform designed to integrate multiple unit operations into a single system.

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