ENABLING END-TO-END CONTINUOUS BIOMANUFACTURING BY EXPLORING INTEGRATION APPROACHES OF CONTINUOUS TFF

摘要

The Downstream Processing (DSP) production/process line comprises of several chromatographic process unit operations (techniques for protein isolation and purification), several liquid filtrations process unit operations and final Ultrafiltration/Diafiltration (UF/DF) process unit operation (process for product concentration to the desired final protein concentration and for exchange into final formulation buffering condition). UF/DF step is conventionally performed with the batch tangential flow filtration (TFF). However, several pump passes and a recirculation skid are required to achieve the target concentration in conventional TFF. Thus, it is impractical to implement batch TFF as continuous UF/DF step or in-line concentration step between different DSP chromatographic steps.