Don ’ t let hidden vulnerabilities disrupt your critical
API supply chain
Ken Ball , API & intermediates commercial lead at Pfizer CentreOne , looks at how to identify and address hidden vulnerabilities in pharmaceutical companies ’ API supply chains before they disrupt business .
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recent industry survey by International Data Corporation and supply chain company TraceLink found that 70 % of supply chain leaders think their supply chain is vulnerable . 1 When timely API supply is a critical part of your drug programme ’ s go-to-market strategy , there is no room for error or unanticipated supply chain disruption to interrupt a product ’ s value chain , especially post-COVID 19 . It is crucial that pharmaceutical companies take steps to spot hidden vulnerabilities in their API supply that could lead to manufacturing delays that are potentially costly and damaging to patients . By identifying these dangers now , drug developers can take steps to address them before they cause problems . Five of the most pressing supply chain considerations are discussed in turn below .
A non-diverse supply chain
Sourcing all of your API from a single supplier may increase risk of supply chain disruption . If a commercial partner cannot deliver an API on time , then this could lead to a lack of vital raw materials and mean drug companies cannot fulfil their own orders . When an API supply stops , mounting losses relative to the programme are sure to follow . These losses are not just immediate and temporary – they can last into the medium- to long-term . As many drug programme managers know , it is not possible to switch suppliers quickly , because qualifying a new one takes between 18 months and two years at the least . In addition , there could be penalties if contractual obligations cannot be met in the meantime .
Vulnerabilities hidden in plain sight
Relying too much on suppliers from one single geographic region can leave a company vulnerable to disruption . To mitigate those risks , it is important to think about creating a more geographically dispersed API supplier . If its primary and secondary API manufacturers are in the same region using the same resources , raw materials and infrastructure , and are governed by the same local regulatory authorities , they all probably share those common risk factors . For example , a deadly 2007 outbreak of blue-ear disease in pigs in a region that produces 80 % of the global supply of the anti-coagulant heparin , which is commonly derived from swine , resulted in acute shortages of the drug worldwide . 2 A study in The Lancet following the outbreak advised global manufacturers to think about broadening their suppliers to regions unaffected by the swine virus . 3
Inflexible supply chains
The agility of an API supply chain is key to ensuring that medicines can be manufactured and delivered to patients on time , even in the face of challenges and disastrous circumstances .
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