Fujifilm Biotechnologies is unveiling a precision purification tool called ShunzymeX, which the CDMO says simplifies downstream processing for complex biologics.

Fujifilm developed the proprietary technology in collaboration with the University of Edinburgh with the aim of streamlining purification processes. That partnership began in 2019 with joint funding from UK Research and Innovation and Edinburgh Innovations.

How Purification Technology Works

Fujifilm explained, in multiple steps, how its technology works:

• It leverages a novel protease to enable purification of complex biologics in a simplified process.
• It adds an affinity tag to the protein, which permits purification of the biologic protein with an off-the-shelf affinity resin.
• Following purification, the novel protease cleaves off the tag—and does not leave a scar on the native protein.

Consequently, Fujifilm hopes customers can advance more quickly toward good manufacturing practice (GMP) manufacturing and Investigational New Drug (IND)-enabling milestones.

The company says ShunzymeX addresses some inherent challenges in traditional microbial downstream purification. Such challenges are due in part to the diversity of microbial-expressed proteins. Variability in size and sequence, among other factors, leads to a lack of suitable affinity resins.

Without a robust affinity chromatography step in the process, traditional approaches beget long development times, and low yield and purity. Conversely, Fujifilm says, streamlining purification can reduce those development timelines. The company claims the ShunzymeX technology is suited to various expression systems. It can also scale direct to current GMP.

Fujifilm Touts ShunzymeX Advantages

Fujifilm said another advantage of ShunzymeX is it can also be paired with the company’s fully automated, highly customizable SymphonX. This technology features an all-in-one equipment design capable of running all downstream unit operations.

Fujifilm Biotechnologies is officially unveiling ShunzymeX at the Festival of Biologics conference in San Diego.