Workflow Evaluation of Key Work Packages in Drug Product Technologies

Abstract

The biopharmaceutical industry is growing more competitive both in the variation of product offerings and in speed to patients. Amgen’s increasing pipeline of promising drugs coupled with their continued focus on delivering drugs to patients faster than before creates an imperative for identifying opportunities to increase efficiency and speed with reduced process development timelines.

The research presents analysis at different altitudes of the Drug Product Technologies (DPT) processes: (1) current state analysis of commercialization milestones across 10 products; (2) current state analysis and discussion of end-to-end study workflows; (3) a case study evaluating a proposal to implement automation to increase efficiency and consistency of study execution. This research incorporates data across all three altitudes to be used in conjunction with methods of process flow mapping, value and non-value-added activity identification from Lean practices and critical path analysis to inform improved understanding of current state processes to help inform future-state investment decisions as discussed with the automation case study for moisture analysis.

Using these methods, the project highlights the report generation process for studies as an opportunity area for enhanced efficiency. On a broader level, we recommend incorporating the processes explored in this research with process flow mapping, critical path analysis, and investment evaluation framework at all three levels more frequently and using the identified data sources to build out the infrastructure to be able to analyze cycle times and critical path analysis dynamically as the processes within work packages evolve. By evaluating work packages at these three levels, we build the case for extending these processes throughout DPT in other studies and using these tools to inform systematic decision-making around investments potentially creating increased efficiency for projects that are proposed and under consideration.