Didier Combis discusses how the pharmaceutical supply chain will need to evolve to address the ‘ new normal ’
Critical medicines depend upon effectively functioning supply chains making it possible to produce the API , which is often the most critical part of a drug , on time . COVID-19 has disrupted travel , economies and commerce in many industries but , considering the inherent complexity of small molecule drug substances , this impact is even more acute for APIs . Temporary trade restrictions and shortages of critical APIs for intensive care have highlighted major weaknesses and vulnerability in drug substance production strategies and supply chains . This crisis will trigger a change of paradigm in the pharmaceutical industry . The tools to implement and monitor an API sourcing strategy will need to be revised to adapt to a new business environment .
Inherent complexity
Compared to other industries , an API production network is usually extremely complex . The components are sourced from all over the planet while regulatory and environmental compliance factors make any change in manufacturing strategy extremely difficult . A typical new chemical entity might have five cGMP steps to the final molecule , using three regulated starting materials , each involving three specific synthetic steps . This would add up to 14 specific transformations . Assuming , as is reasonable , two chemical reagents per step , that means a total number of individual chemical components to 28 . Thus , at least 20 manufacturing sites will be involved in synthesising the final drug substance . At atom level , there is a good chance that certain carbon or halogen components in the final molecule will travel twice around the globe for routine production , even leaving aside the tax incentive for producing the final API in Singapore or Ireland before going on to Puerto Rico for formulation and becoming a drug product .
Fragile existing chains
In addition to the intrinsic complexity of the drug molecule , which implies a broad range of technologies and companies , and the regulatory and quality framework , cost factors and modern operational tools have also driven supply chain complexity . Pharmaceutical companies looking for cost reductions and using tools like lean manufacturing have optimised their API manufacturing and purchasing strategies , adding risk and complexity . Obviously , there is an important difference in sourcing behavior between generic and patented APIs , where the cost factor is not as important . In either case , during the past ten years , we have seen a rise in global networks , where regional sourcing strategies
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