As biopharma trends toward smaller batch sizes and more intensified, flexible production, interest continues to grow in technologies that enable these trends. Single-use equipment for fast changeover between products, alternative ways of operating a chromatography column (such as rapid cycling), or even new formats are all potential solutions. The Fibro PrismA protein A chromatography format is a single-use technology that enables high mAb capacities at high flow rates and short residence times. In mAb production with low annual demand or in clinical production, the Fibro PrismA format can reduce adsorber cost and increase productivity compared to standard protein A resin column operations.<br/>Rapid cycling can be done with protein A resin columns, but to generate the highest productivity, the column bed height and residence time must be reduced. The limitations of chromatography resins are their pressure/flow characteristics and binding capacity, where mass transfer is limited by diffusion into the particles. For Fibro, the highest productivity is obtained at the shortest possible residence time where the flow rate is restricted by the pressure limits of the chromatography system.<br/>There are different options for operating Fibro PrismA using installed base chromatography systems at pilot and process scale. A true single-use solution — operating the Fibro unit on a single-use system — may be the preferred combination. However, for single-use systems and flow paths, limitations related to compatibility with CIP chemicals or pressure tolerance may restrict full utilization of the Fibro PrismA capability. Here we’ll outline different combinations of Fibro PrismA units and chromatography systems operating at different flow rates. We’ll discuss benefits and drawbacks of single-use and stainless-steel systems, as well as the effect of different system hold-up volumes compared to the Fibro unit sizes.

System considerations for fibro protein A rapid cycling in GMP manufacturing

ACS Spring 2022

The official archive and repository for all ACS Meetings & Expositions abstracts and select posters or presentations.