Improvements to Perfusion Skids 66501/66502/66503 Operations Used for Enbrel Product in AML-06

Abstract

Amgen AML-06 Drug Product Plant is a multi-product facility where therapies for chronic diseases are manufactured. Its systems are designed for the continuous improvement of the processes, in order to comply with the supply requirements for medications. The project to be worked will impact the manufacturing process specifically for the Perfusion process of Enbrel product. The perfusion process is carried out in Bioreactor N-1, a previous step to Bioreactor N where the protein is finally produced. The team will be working with symptoms in the Perfusion equipment, which cause the process time to exceed the validated limits. To achieve this, we will use the DMAIC methodology, with the intention of improving an implemented process. The goal is that we can implement improvements to the process and that the time of the process is within the established ranges, and thus not impact the integrity of the cells or the schedule of the lots. To meet the goal, it is necessary to achieve a reduction of at least 6% of the processing time. Key terms ⎯ logical control, mechanical seal, perfusion, SIP