Lean Manufacturing and PAT Could Offer Substantial Efficiencies

Pharmaceutical manufacturers could retain 6 percent of revenue through cost savings in production efficiencies by using process analytical technologies (PATs) and lean manufacturing principles, making them as productive as firms in other industries, according to a recent study. Much of the savings result from reduced inventories.

“The combined deployment of [PAT] and lean manufacturing offers extraordinary financial opportunities for pharmaceutical manufacturers at every scale,” Robert Cogdill, industrial research coordinator for the Duquesne University Center for Pharmaceutical Technology, says in a study published in the latest issue of the Journal of Pharmaceutical Innovation.

The estimates are based on a hypothetical case study of a midsize generic drugmaker operating on a single technology platform using high-shear wet granulation technology with multiple drug products generating $450 million in annual sales, Cogdill and his co-researchers say. Operating metrics of their model, such as inventory turnover rates, were derived from industry data.

“Given the current state of manufacturing performance in the pharmaceutical industry, only relatively modest improvement in process capability and supply chain velocity are needed to realize outsized gains,” the study says.

In the model, the researchers assume this hypothetical firm wants to improve manufacturing operations by developing procedures and deploying technologies to reduce quality control hold times and variability in process cycle times, thereby enabling real-time release of finished product.