The Financial Returns on Investments in Process Analytical Technology and Lean Manufacturing: Benchmarks and Case Study

The combined deployment of process analytical technology (PAT) and Lean manufacturing offers extraordinary financial opportunities for pharmaceutical manufacturers at every scale. While many articles have been published describing the economic and quality opportunities presented by improved pharmaceutical manufacturing performance, greater understanding of the financial benefits of PAT and Lean at the individual company level is needed to support accurate valuation of corporate investments in manufacturing performance upgrades. This paper describes research using industrial benchmarks and published data for publicly-traded companies to demonstrate the value potential posed by combined deployment of PAT and Lean in pharmaceutical manufacturing operations. A method of estimating the financial return on investments in PAT and Lean is described by considering their impact on the profitability of a hypothetical mid-sized generic pharmaceutical manufacturer. The results of the case study show that based on benchmark data for the generic drug manufacturers, it is possible to return savings of up to 6% of revenues by improving process capability and supply chain management through strategic deployment of PAT and Lean manufacturing.

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