By Linnea Troeng, David Westman, Matthew Townsend, Ian Scanlon, Oliver Hardick, Jinyu Zou, and Tuomo Frigard
Biomanufacturing is trending towards increased number of monoclonal antibody (mAb) projects and smaller batch sizes, with production of most mAbs expected to be below 150 kg/yr*. This puts new demands on number of clones to be screened, efficient process development (PD), and flexible, scalable bioprocess manufacturing design. In multiproduct facilities easy and fast changeover between campaigns is becoming essential. This is driving adoption of efficient single-use technologies.
Here, we present a technology that brings new capabilities to address these needs. Rapid cycling, fiber-based chromatography (Fibro) enables substantially reduced purification times in research and PD and a single-use solution in manufacturing. Fibro chromatography supports relatively high capacity with residence times of seconds and allows full chromatographic runs in a few minutes per cycle. We describe a versatile solution that substantially increases throughput in research and PD and maintains consistency over cycles. A large-scale prototype run demonstrates consistent performance over cycles and scalability.