Fujifilm's ShunzymeX Aims to Revolutionize Biologics Purification

TEESSIDE, England – March 03, 2026 – FUJIFILM Biotechnologies has unveiled a groundbreaking technology poised to remove a critical bottleneck in the production of advanced medicines. The new platform, named ShunzymeX™, is a precision purification technology designed to dramatically simplify and accelerate the manufacturing of complex biologics, potentially speeding the delivery of new therapies and vaccines to patients.

The innovation was officially announced this week at the prestigious Festival of Biologics conference in San Diego, where the company detailed how ShunzymeX addresses long-standing challenges in downstream processing.

Tackling a Critical Bottleneck in Biomanufacturing

For decades, the biopharmaceutical industry has grappled with the complexities of downstream processing—the series of steps required to isolate and purify a biologic drug from the complex mixture of cellular components in which it is produced. This purification phase can account for a significant portion of total manufacturing costs and often represents the slowest and most challenging part of the development cycle, particularly for proteins expressed in microbial systems like E. coli.

To manage this complexity, scientists often use a technique called affinity tagging. An affinity tag, a small protein or peptide sequence, is attached to the target biologic. This tag acts like a handle, allowing the desired protein to be easily captured and separated from thousands of other host cell proteins using an off-the-shelf purification medium, or resin. While effective for initial capture, the critical challenge comes in the next step: removing the tag.

Traditional methods rely on proteases—enzymes that act as molecular scissors—to cleave the tag from the therapeutic protein. However, these methods are often imperfect. In many cases, the cleavage process leaves behind a few extra amino acids on the final protein, a remnant known as a "scar." This seemingly minor alteration can have major consequences, potentially impacting the protein's structure, function, stability, and even its immunogenicity, which could trigger an adverse reaction in patients. Overcoming this issue often requires additional, time-consuming purification steps, driving up costs and extending development timelines.

The ShunzymeX Solution: 'Scar-less' Precision

ShunzymeX technology was engineered specifically to solve this problem. Developed through a multi-year collaboration, the platform is centered on a novel, proprietary protease. This unique enzyme is designed to recognize and cleave the affinity tag with exceptional precision, removing it completely without leaving any residual amino acids. The result is a 'scar-less' therapeutic protein that is identical to its native form.

"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," said John Stewart, senior vice president of Global Process Development, FUJIFILM Biotechnologies. "Together, we believe this innovation will help create a faster path for our customers to commercialization."

By streamlining the purification process, ShunzymeX is expected to significantly reduce process development timelines, a key advantage for drug developers racing to reach Investigational New Drug (IND) enabling milestones and initiate clinical trials. The company states the technology is robust, scalable directly to current Good Manufacturing Practices (cGMP) standards, and compatible with various microbial expression systems. Furthermore, it can be integrated with SymphonX™, Fujifilm's fully automated downstream processing platform, creating a powerful, end-to-end solution for efficient biomanufacturing.

Kenneth Holbourn, senior director at FUJIFILM Biotechnologies, who will present the technology in San Diego, highlighted the significance of the launch event. “We’re excited to introduce ShunzymeX at the Festival of Biologics... it is the perfect forum to showcase how ShunzymeX can help streamline purification for microbial products.”

A Strategic Alliance of Academia and Industry

The development of ShunzymeX is a testament to the power of collaborative innovation, born from a strategic partnership between FUJIFILM Biotechnologies and the University of Edinburgh. The alliance, which began in 2019, was established to merge deep academic research with industrial-scale application, with joint funding from UK Research and Innovation (UKRI) and support from Edinburgh Innovations, the university's commercialization arm.

The project leveraged the expertise of leading academics, including Professor Susan Rosser, an expert in synthetic biology, and Professor Emerita Lynne Regan, whose research focuses on protein design and engineering. Their foundational science on novel proteases provided the scientific bedrock upon which the ShunzymeX technology was built.

“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,” said Professor Rosser. “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.”

Solidifying Market Leadership and Accelerating Future Therapies

In the highly competitive contract development and manufacturing organization (CDMO) market, proprietary technologies that solve critical client problems are a key differentiator. With ShunzymeX, FUJIFILM Biotechnologies not only enhances its service portfolio but also solidifies its position as a leader in microbial-based biomanufacturing.

By offering a solution that promises higher purity, reduced timelines, and a cleaner final product, the company is well-positioned to attract biopharmaceutical clients developing complex next-generation biologics. The 'scar-less' feature is a particularly compelling advantage, as it directly addresses regulatory concerns about product quality and consistency, potentially smoothing the path to market approval.

This innovation aligns with the company's broader strategy of investing in advanced technologies to meet the growing global demand for biopharmaceuticals. By removing a significant hurdle in the manufacturing process, ShunzymeX stands to have a tangible impact on the entire drug development ecosystem, enabling scientists to advance promising candidates from the lab to the clinic more efficiently than ever before.