Augmenting drug process development capacity through applications of lean principles and high throughput technology

Abstract

The long development lead time and high R&D costs for biologics drugs makes it imperative to eliminate delays and inefficiencies. Limited process development capacity can lead to delays in the availability of life-saving drugs and a large opportunity cost for biopharmaceutical companies. This study investigates the combined viability and impact of two approaches, namely applying lean principles and using high-throughput technology to increase capacity and productivity in pivotal biologics drug process development. Specifically, the project will explore a framework for improved handoffs and work design, and propose management systems to sustain implementation. In parallel, the study tests the sensitivity of the process development cycle to various resource constraints through a discrete event simulation and develops heuristics for the effective use of high-throughput equipment in upstream and downstream processes to increase process development capacity. The two approaches identified a potential increase in throughput of 2.75X (+175%) in preparation for an anticipated 2.3X (+129%) growth in biologics program demand in pivotal process development.