After FUJIFILM Biotechnologies announced its precision purification technology, the company shared further insights in an extended Q&A.
FUJIFILM Biotechnologies
What is ShunzymeX?
ShunzymeX is a proprietary purification technology developed by FUJIFILM Biotechnologies in collaboration with the University of Edinburgh. It is designed to simplify downstream processing for complex microbial-expressed biologics by enabling a standardised affinity purification step, followed by tag removal without leaving residual amino acids on the target protein.
How does ShunzymeX work?
ShunzymeX enables the addition of an affinity tag to a target protein during expression. This allows the protein to be captured using an off-the-shelf affinity resin, allowing the biologic protein to be purified with an off-the-shelf affinity resin.
After purification, a proprietary protease cleaves the affinity tag without leaving a “scar” — residual amino acids that can affect protein structure or function. The result is a purified protein that retains its native sequence.
What challenge does this technology address?
Microbial-expressed proteins vary significantly in size, structure, and sequence. Many lack suitable affinity resins, which can make downstream purification complex and highly customised.
In the absence of a robust affinity capture step, developers may rely on multistep purification strategies that can increase development timelines and process variability.
ShunzymeX is designed to introduce a standardised affinity step, which may reduce process complexity, improve reproducibility, and support a more efficient transition to good manufacturing practices (GMP) manufacturing.
How does ShunzymeX differ from existing affinity tag systems?
Traditional affinity tag systems may leave residual amino acids after cleavage, which can affect protein binding or function. ShunzymeX is designed to enable tag removal without altering the native protein sequence.
In addition, the technology is intended to integrate into existing microbial expression workflows and scale directly into current good manufacturing practices (cGMP) environments.
When will ShunzymeX be available to customers?
ShunzymeX is available immediately for customer programs. FUJIFILM Biotechnologies is currently in discussions with multiple customers regarding integration of the technology into ongoing development programs.
As a CDMO, the company does not disclose specific client programs.
Has ShunzymeX been used in GMP programs?
The platform is designed to be scalable and compatible with cGMP manufacturing. Implementation within GMP programs will depend on individual customer project timelines and regulatory strategies.
Are there regulatory considerations associated with this technology?
As with any process modification, incorporation of ShunzymeX would be assessed within the context of a customer’s regulatory filing strategy. The technology is designed to support regulatory compliance by enabling removal of the affinity tag and minimising sequence alterations.
Regulatory documentation would include appropriate characterisation of the protease, tag removal efficiency, and impurity clearance.
Is the ShunzymeX protease removed during processing?
Yes. The process is designed to ensure that the protease and any associated impurities are removed as part of downstream purification. Appropriate analytical characterisation is performed to confirm clearance in line with regulatory expectations.
Is ShunzymeX only available for microbial?
The initial launch focuses on microbial expression systems. The company is evaluating potential future applications in mammalian-expressed proteins.
Is this technology exclusive to FUJIFILM Biotechnologies?
Yes, ShunzymeX, a proprietary technology, was developed via a partnership with the University of Edinburgh. FUJIFILM Biotechnologies holds a perpetual, exclusive global license to the technology.
What are the licensing terms of ShunzymeX?
Under the agreement, the University of Edinburgh granted FUJIFILM Biotechnologies a perpetual, exclusive global license to the ShunzymeX technology for commercial application.
The technology is currently offered as part of FUJIFILM Biotechnologies’ CDMO service portfolio.
How does ShunzymeX support faster GMP readiness?
By introducing a standardised affinity purification step early in development, ShunzymeX is designed to reduce process variability and streamline process development activities.
This may support a more efficient transition from early-stage development to GMP manufacturing, depending on the specific product and regulatory pathway.
Have you generated comparative data on yield or timelines?
Process performance outcomes depend on the specific protein and development program. FUJIFILM Biotechnologies is continuing to evaluate performance across customer-relevant models.
Where appropriate, performance data will be shared directly with customers under confidentiality agreements.
How does this strengthen Fujifilm’s microbial platform?
FUJIFILM Biotechnologies has more than 30 years of experience in microbial expression and process development. ShunzymeX expands the company’s proprietary microbial toolkit and is designed to complement its Paveway expression system and downstream development capabilities.
Why launch at Festival of Biologics?
Festival of Biologics brings together scientists and manufacturing leaders focused on advancing biologics development. The event provides an opportunity to present technology to a global audience of process development and manufacturing professionals.
Do you have any customers currently using ShunzymeX?
As a CDMO, we do not disclose our customers due to confidentiality; however, we are already in dialogue with several customers about this technology.
Do any other CDMOs offer similar technology?
Several purification approaches exist across the industry. ShunzymeX is proprietary to FUJIFILM Biotechnologies and was developed through a collaboration with the University of Edinburgh.
The company’s focus is on integrating this technology within its broader microbial development and manufacturing platform.
Will this create new hiring or investment?
ShunzymeX builds on existing microbial development infrastructure. Any additional investment or staffing would align with customer demand and program growth.