Biomanufacturing is trending towards higher numbers of monoclonal antibody (mAb) projects and smaller batch sizes. These trends are fueling demands to screen more clones faster, and improve the efficiency of process development and flexible multiproduct facilities in mAb manufacturing.

‘For large-scale manufacturing it increases flexibility and productivity’ 

“To help meet these needs, Cytiva developed ready-to-use Fibro PrismA units for capturing mAbs”, says David Westman, Bio Process Marketing Manager at Cytiva. “Our first-launched products are HiTrap Fibro PrismA and HiScreen Fibro PrismA. Both are designed to support researchers and process developers by enabling them to purify monoclonal antibodies with significantly improved throughput.”

Fibro PrismA, as Westman explains, is a scalable rapid cycling chromatography technology that complements chromatography resins, especially in circumstances where speed and flexibility are important. It offers significantly improved mAb purification throughput in research and process development. Westman: “For large-scale manufacturing it increases flexibility and productivity through its single-use operations. This creates substantial cost savings, especially for multiproduct facilities, and helps bring therapies to market faster.”

Minutes instead of hours

Fibro PrismA units have a protein A cellulose fiber matrix with an open pore structure. In this matrix, mass transfer is governed by convective flow. This structure allows high mAb binding capacities at very short residence times, which results in cycle times of minutes instead of the hours needed for resin-based chromatography. “Fibro PrismA uses the same chromatography systems, infrastructure, and ligands as resin chromatography”, stresses Westman, “allowing for simple transition into existing biomanufacturing facilities.” 

In research and process development, the fast purification time results in up to 20 times increased throughput compared to resins. In clinical and commercial settings, the rapid cycling enables manufacturers to utilize the full lifetime of the unit (around 200 cycles) in a single batch-increasing productivity up to 400 g/L/h. “For clinical manufacturing, where you normally only utilize a fraction of the full lifetime of resins, this means significantly reduced cost”, says Westman. “In commercial manufacturing, the Fibro technology enables cost-efficient single-use operations with added flexibility for multiproduct facilities.”

Application areas

The beauty of the Fibro platform lies in its versatility, concludes Westman. “All ligands available for resins may also be attached to the Fibro units. Its macro porosity gives it a strong potential for usage in vaccine and viral vector purification. In the coming years, we plan to develop products for these areas.”