Design and Implementation of Buffer Multi-batch in the Biopharmaceutical Industry

Abstract

In this research, an analysis of buffer consumption was performed throughout buffer and FBP manufacturing processes to determine if the current buffer batch size of 200 kg or 600kg is enough to prepare more than one FBP batch or if the buffer batch size should be increased. Also, if the proposed multi-batch buffer is a viable option for the manufacturing processes in the studied biopharmaceutical industry. To execute the design and implementation of the buffer multi-batch strategy for the industry, the DMAIC methodology was used, resulting in a reduction of 18 hours per batch of cycle time. Key Terms - Buffer, Consumption, DMAIC, Multi-batch.