Evolution of the Fibro chromatography platform: Scale-up and what is beyond mAbs
Fibro chromatography for scalable monoclonal antibody (mAb) purification was recently launched to address the evolving needs of drug developers and manufacturers. This single-use technology uses a highly alkaline-stable, engineered protein A PrismA ligand.
The rapid cycle times, which Fibro chromatography enables, present a new paradigm for process development. Hundreds of process parameter conditions can be investigated each day using ÄKTA™ chromatography systems and UNICORN™ control software. For large-scale manufacturing, the technology offers new processing strategies with processing of about 15 kg mAbs per day.
Here we will showcase the technology’s current state and outline the roadmap for future development of the platform. We will show data from large-scale protein A capture Fibro units for GMP-regulated work. The integration of the Fibro capture step into a complete mAb process will also be shown. We will discuss future developments regarding other ligands and applications for the fiber matrix, including mAb polishing, capture and resolution of larger therapeutic complexes.
Staff Research Engineer, Cytiva
Ian Scanlon has over 20 years experience in separation and chromatography, ranging from small molecule therapeutics, through modified triphosphates, DNA and proteins. For the past five years Ian has been part of the development of the Fibro Chromatography technology, working with groups across biopharma in the EMEA and the US to develop applications.