ABSTRACT
The role of the Pilot Plant in the drug development process is especially significant for biotech products. The challenge when applying Lean in the Pilot Plant is that the thinking must shift from product specific, process stream-based optimization to optimization of the key processes around each unit operation. The Pilot Plant Services (PPS) organization consists of two unit operations, cell culture and purification. The cell culture group managed both small-scale and large-scale process streams. This value stream mapping effort focused on the establishment of a cVSM as an assessment tool for identifying Value Added (VA), Business Value Added (BVA), and Non-Value Added (NVA) activities in the process. While it was understood that the Pilot Plant team had been working actively to drive down failures due to Miniferm contamination, the trending analysis did not provide conclusive proof of their success.
