Learn About The Development Of Protein A Continuous Chromatography

Rapid advances in intensifying upstream processes for biologics production to achieve higher titers have left downstream processing as a potential bottleneck in the manufacturing scheme. Multicolumn continuous chromatography (MCC) is an emerging technology that can significantly reduce material costs and time in plant. This mode of chromatography can lead to shorter processing times and improve efficiency as well as productivity compared to a traditional batch process. Implementation of a fully integrated end-to-end continuous process has been limited due to the complexity and scalability of the process. A hybrid approach of converting the Protein A (ProA) capture chromatography step to a continuous chromatography process offers many of the advantages of a MCC process while avoiding the challenges associated with connecting process steps.

Learn about the development of Protein A continuous Chromatography with an expert speaker from KBI Biopharma, a global CDMO and one of JSR Life Sciences affiliated company. This presentation will focus on the conversion of a batch ProA step using Amsphere A3 resin to a 4-column continuous process on a BioSMB system. We evaluated the number of columns and resin volume needed to achieve balanced savings between resin/buffer usage and processing time when scaling up the process across a range of feed titers. The continuous process achieved similar yield and product quality compared to the batch process. Depending on the column sizing and input volume for a scale-up process, we estimated up to 80% savings in ProA resin, around 20% savings in buffer usage, and a 3- to 5-fold increase in output productivity with the continuous process compared to the batch process. Overall, this study supports a continuous ProA development approach that offers advantages over a traditional batch ProA step and is compatible with KBI’s development approach that allows for the development of robust processes in short development timelines.