By Iwan Roberts
The dominant technique for chromatographic purification in today’s pharmaceutical industry uses highly porous microscale beads with a functionalized surface to allow discrimination of drug product from the complex process stream. For example, with a Protein A ligand on the surface, monoclonal antibody (mAb) purification is mediated via an affinity interaction. However, as the biopharmaceutical market continues to evolve and grow to adapt to clinical and economic drivers, there is an increasing need to improve both intensification and flexibility of facilities. To address this, new technologies that increase productivity and are economical in single-use operation are required across unit operations, leading to the exploration of alternatives to porous beads.
One such technology is Fibro, which uses a novel proprietary structure that overcomes the diffusional and flow limitations of packed bed chromatography purification systems. It also aims to address capacity issues of chromatography membranes, which have limited their application to predominantly contaminant capture steps. The new adsorbent material has the capability to not only improve process flexibility and robustness but also meet the demands of the rapidly changing biopharma landscape.