Launching at the Festival of Biologics, ShunzymeX is designed to streamline process development and accelerate GMP readiness for complex biologics.
TEESSIDE, England–(BUSINESS WIRE)–FUJIFILM Biotechnologies, a world leading contract development and manufacturing organization (CDMO) for biologics, vaccines, and advanced therapies, today unveils ShunzymeX precision purification technology, which simplifies downstream processing for complex biologics. The technology will be presented this week at the Festival of Biologics conference in San Diego.
To streamline purification processes, FUJIFILM Biotechnologies, in collaboration with the University of Edinburgh, developed ShunzymeX, a proprietary technology that leverages a novel protease to enable purification of complex biologics with a simplified process. This innovative technology enables the addition of an affinity tag to the protein, allowing the biologic protein to be purified with an off-the-shelf affinity resin. After purification, the novel protease cleaves off the tag without leaving a scar on the native protein1. The technology is expected to streamline the process development stage to help customers advance more quickly toward GMP2 manufacturing and IND3-enabling milestones.
ShunzymeX addresses some of the inherent challenges in traditional microbial downstream purification due to the diversity of microbial-expressed proteins, including variability in size and sequence, leading to a lack of suitable affinity resins. In the absence of a robust affinity chromatography step, traditional downstream approaches can result in long development times, low yield, and low purity. By streamlining purification, ShunzymeX can reduce process development timelines. In addition, the technology is suitable with various expression systems, and scalable direct to cGMP4.
“FUJIFILM Biotechnologies has more than 30 years of experience in microbial innovations, exemplified with our Paveway5 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.”
“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,” said Kenneth Holbourn, senior director, technical project leader group, FUJIFILM Biotechnologies. “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.”
ShunzymeX can be paired with SymphonX™, FUJIFILM Biotechnologies’ fully automated and highly customizable technology featuring an all-in-one equipment design to run all downstream unit operations.
The new purification technology will be presented in a session titled, “Accelerating and Streamlining Microbial Process Development with a Novel Technology,” by Holbourn on March 4, 2026 at 2:50pm PT in Theater 5 at the Festival of Biologics.
The strategic partnership between FUJIFILM Biotechnologies and the University of Edinburgh began in 2019, with joint funding from UK Research and Innovation and supported by Edinburgh Innovations, the University’s commercialization service, to accelerate the development of biologics.
Academic lead for the partnership, Professor Susan Rosser, said: “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.”
For more information, please visit https://fujifilmbiotechnologies.fujifilm.com/capabilities/biologics/microbial-fermentation/downstream-process-development/.
About FUJIFILM Biotechnologies
FUJIFILM Biotechnologies, made up of several legal subsidiaries of FUJIFILM Corporation, is a world-leading contract development and manufacturing organization (CDMO) for biologics, vaccines and advanced therapies. With over 30 years of experience, the Company specializes in developing and manufacturing biopharmaceuticals using microbial, mammalian, and host/virus systems. With over 5,000 employees, FUJIFILM Biotechnologies operates a fully integrated, kojoXTM global network with major facilities in the United States, the United Kingdom, and Denmark. The Company’s kojoX manufacturing network ensures supply chain agility for its customers through modular facilities and standardized processes for seamless scaling and technology transfers. FUJIFILM Biotechnologies offers comprehensive services, ranging from proprietary cell line development, to process and analytical development, and through to clinical and commercial manufacturing. For more information, go to: fujifilmbiotechnologies.fujifilm.com.
About FUJIFILM Holdings Corporation
FUJIFILM Corporation is a subsidiary of FUJIFILM Holdings Corporation. FUJIFILM Holdings Corporation, headquartered in Tokyo, leverages its depth of knowledge and proprietary core technologies to deliver innovative products and services across the globe through the four key business segments of healthcare, electronics, business innovation, and imaging with over 70,000 employees. Guided and united by our Group Purpose of “giving our world more smiles,” we address social challenges and create a positive impact on society through our products, services, and business operations. For more information, please visit: www.FUJIFILMholdings.com. For further details about our commitment to sustainability and FUJIFILM’s Sustainable Value Plan 2030, click here.
About Edinburgh Innovations
Edinburgh Innovations is the University of Edinburgh’s commercialization service. We bring University of Edinburgh research to industry, working to identify ideas with value, and facilitating the process of bringing them to life in real-world applications.
We make ideas work for a better world. Visit our website
1 With traditional methods, the tags leave a scar on the target protein, which can impact some of the important attributes of how a protein binds and functions.
2 Good manufacturing practices
3 Investigational new drug
4 Current good manufacturing practices
5 Paveway PLUS is a E. coli expression system with >150 different therapeutic proteins successfully expressed.
Contacts
Fujifilm Media Contact:
Christine Jackman
FUJIFILM Biotechnologies
[email protected]
914-261-4959
Edinburgh Innovations Media Contact:
Megan Welford
Edinburgh Innovations
[email protected]
07721 120217
