FUJIFILM Biotechnologies, has announced 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.
FUJIFILM Biotechnologies
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 protein. The technology is expected to streamline the process development stage to help customers advance more quickly toward GMP manufacturing and IND-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 cGMP.
“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 commercialisation.”
ShunzymeX can be paired with SymphonX, FUJIFILM Biotechnologies’ fully automated and highly customisable technology featuring an all-in-one equipment design to run all downstream unit operations.
The new purification technology was presented in a session titled, “Accelerating and Streamlining Microbial Process Development with a Novel Technology,” by Holbourn on 4th March 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 commercialisation 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.”