The early phase projects often focus on development speed rather than process performance as it is the stepping stone to initiate the clinical trials faster. There is considerable time between the clinical phases to identify, measure, analyse and improve existing processes through process intensification (PI). PI has been applied for downstream processing of monoclonal Antibodies (mAbs) largely through continuous processing or process integration along with Process Analytical Techniques (PAT) to get benefits in terms of process robustness and economy.<br/>Here we intent to present two case studies describing the strategies employed as part of a process intensification to improve the productivity, efficiency and robustness of the processes.<br/>The first case study will demonstrate an intensified Cation exchange chromatography (CEX) process for mAb A by modifying the elution conditions and implementing PAT based pooling. The modification of the elution gradient resulted ~30 % increase in yield. Moreover, online-PAT implementation helped in further improving the yield by ~3-5% along with improving the process robustness and maintaining the product quality.<br/>The second case study will describe the intensification of the downstream process for mAb through integration of various unit operations. The bottleneck in downstream process integration was the CEX step which was in bind and elute mode. The conversion of the CEX step to flow-through mode facilitated the downstream process integration thus reducing the processing time, operator interventions and demonstrating higher productivity than a batch based process. This also enhanced the process efficiency without altering the product quality and yield.

Process Intensification: Case studies in downstream processing of monoclonal antibodies

2019 Spring National Meeting

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