Fujifilm Biotechnologies has launched ShunzymeX, a breakthrough precision purification technology designed to enhance downstream processing efficiency, yield, and purity in biopharmaceutical manufacturing. The novel resin-based system targets challenging impurities (host cell proteins, aggregates, DNA) with unprecedented selectivity, reducing process steps, shortening timelines, and lowering costs for monoclonal antibodies, bispecifics, gene therapies, and other complex biologics.
Glimpse:
Unveiled on January 27, 2026, ShunzymeX utilises proprietary ligand chemistry and advanced bead design to achieve higher impurity removal in fewer chromatography steps compared to traditional Protein A and ion-exchange methods. Early adopter data from contract development and manufacturing organisations (CDMOs) and biopharma partners show 20–40% improvement in overall yield, up to 50% reduction in buffer usage, and significant time savings in purification critical advantages for high-titre, high-volume biologics production. The technology is now commercially available for process development and scale up.
Fujifilm Biotechnologies has introduced ShunzymeX, a next generation precision purification technology that promises to transform downstream processing in biopharmaceutical manufacturing. The launch, announced on January 27, 2026, addresses one of the industry’s persistent bottlenecks: the need for more selective, efficient, and cost-effective impurity removal as biologics become increasingly complex (high-titre mAbs, bispecific antibodies, ADCs, gene/cell therapies).
ShunzymeX is a resin-based chromatography solution that employs a novel, high-selectivity ligand combined with optimised bead matrix and pore structure. Unlike traditional Protein A affinity or ion-exchange resins that rely on broad physicochemical interactions, ShunzymeX targets specific impurity classes (host cell proteins, DNA/RNA, aggregates, endotoxins) with much higher specificity. This enables:
- Superior impurity clearance in a single step where multiple steps were previously required
- Higher product recovery and overall process yield (reported 20–40% improvement in early case studies)
- Reduced buffer consumption and processing time (up to 50% less buffer, 30–50% faster cycle times)
- Lower capital and operational costs through simplified process design and smaller downstream footprint
The technology is compatible with both batch and continuous manufacturing modes and has shown robust performance across a range of monoclonal antibodies, bispecifics, Fc-fusion proteins, and viral vectors. Early collaborator feedback from CDMOs and biopharma companies highlights its ability to handle high-titre feeds (10–15 g/L) without column fouling or capacity loss, and to significantly reduce the need for additional polishing steps.
Fujifilm Biotechnologies leadership stated: “Downstream purification remains one of the most time-consuming and costly parts of biologics manufacturing. ShunzymeX changes that equation delivering higher purity and yield with fewer steps, less buffer, and lower overall cost. It’s a direct response to the industry’s need for more efficient, scalable, and sustainable bioprocessing solutions.”
The product is now commercially available for process development, scale-up, and GMP manufacturing. Fujifilm is also offering process development support, resin screening services, and custom resin modifications for challenging molecules. The company plans to expand the ShunzymeX family with additional selectivity profiles tailored to emerging modalities such as mRNA, cell/gene therapies, and antibody drug conjugates.
The launch aligns with the industry’s push toward intensified, continuous, and cost-effective biomanufacturing where purification efficiency directly impacts overall COGS (cost of goods sold) and time to market for life-saving therapies.
“ShunzymeX isn’t just an incremental improvement it’s a step-change in how we think about purification. Higher selectivity means fewer steps, less waste, and faster delivery of biologics to patients.”
By
HB Team
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