By Lukas Utiger, President Drug Substance, Patheon, and Mike Mencer, Vice President PDS Operations & Global Integrated Offering
The pharmaceutical industry lags in the sophistication and performance of its supply chains when they are compared with best-in-class companies in other industries. This is due to the complexity that has come with new drugs, more complex production technologies and evolving regulatory requirements. In this environment, integrating and aligning the supply chain makes it more flexible, bolstering operational performance and financial competitiveness.
The complexity of drug product supply chains has increased in recent years thanks mainly to the development of more complex chemical molecules (with more synthesis steps), more suppliers and geographies in the chain, and reduced average production volumes. Preparing for commercial release, the time from raw material to finished drug product can be as long as two years, and those months are fraught with hazards that can cause delays and rework, leading to extra costs, stock-outs and poor capacity utilization.