Pharmaceutical resilience is essential to strengthening the U.S. drug supply chain against shortages, global dependencies, and emerging risks.
Pharmaceutical manufacturing is easily one of the world’s most structured enterprises. For good reason, patients, families and healthcare providers should be able to rely on a safe, reliable supply of vaccines and medications to treat and manage illness.
But government agencies, academics and pharma executives all say the U.S. pharmaceutical supply chain is becoming more vulnerable, with more persistent drug shortages, dependence on overseas production, and political, cyber and biological threats.
How can this be? With heavier regulation, strict safety standards from the International Standards Organization (ISO), US Pharmacopeia (USP) and customer demand for no mistakes, pharmaceutical production should be straightforward. But sometimes, compliance can make things rigid — single suppliers of key ingredients, outsourcing to vendors who do things one way — can thwart the one factor that can keep manufacturing running smoothly: resilience.
Resilience — the ability to be flexible and adapt to extenuating circumstances—can keep your manufacturing going or at least get it moving in a better direction. While compliance can usher in rigidity, there’s more than one way to do things (in fact, US FDA regulations overall work from this philosophy, even though they have stringent outcome requirements)!
A manufacturing failure can be handled in two ways: shutting down a process or finding another method or process pathway. Either way, resilience means learning from failure or near-failure and figuring out how to do better.
According to a recent National Academies of Sciences meeting at Johns Hopkins University, COVID-19 and more recent trade disruptions have exposed the depths of pharmaceutical supply chain risks. These risks stem from quite a few origins:
- Data gaps and limited visibility of where drugs and components are manufactured
- Not distinguishing between routine market availability and consequential and strategically significant risks
- Understanding variations in supply concentration, foreign dependency, manufacturing complexity and quality performance, and looking at strategic options
- Making the connection between pricing, reimbursement, procurement, and reliability, redundancy and domestic and allied production
- Ranking distribution, logistics, regulatory feasibility data, visibility, workforce readiness and durability of actions and infrastructure to determine whether your decisions mean reliable access to drugs
- Preserving flexibility with scenario planning, stockpiling, and vendor-managed inventory
- Coordinating governance and authority
Seeing unseen building blocks
The USP last year identified key starting materials, which are those that are a significant structural fragment of the structure of an active ingredient and will likely continue be used, as a supply chain challenge. Some starting materials, like reagents, solvents and catalysts, undergo chemical transformations before they can produce API, and many companies have chosen to offshore the manufacturing of these chemicals. USP has since pointed to these as potential points of failure, because of their concentrated manufacture in China and India.
Need for transparency
For resiliency to truly maintain reliable drug supplies, everybody along the processing line needs to be aware of how things work correctly, and spot when things go wrong. Even if fixing a mistake or defect is costly, not identifying it is costlier. Everyone must feel free to admit a mistake occurred. For many companies, leaders talk about a “safety culture,” where standards include safety for workers, the environment, and the company’s products.
Safety and ability to learn from mistakes are all important facets of resilience. Today’s economic and geopolitical environment are just adding more challenges to resiliency.
At their meeting, the National Academies of Sciences highlighted their approach to resilience in pharmaceutical manufacturing with “Make, Buy and Invest” strategies.
Make—shifting to onshore manufacturing, finding key partnerships for upstream and downstream processing, improving drug making methods overall
Buy—Adopting Good Manufacturing Practices (cGMP), modernizing factories and equipment
Invest—Using new technologies (including software and AI assistance), new verification and testing methods, even if not specifically called for by regulatory authorities
At Ritedose, we may not have all our processes as “Make, Buy, Invest” but these strategies make up what we do. We have increased our US-based manufacturing capacity, adopted new drug-making machinery and methods, follow cGMP, trained our staff to boost safety, reliability and to spot issues and use modern verification and testing methods.
Tell us about your pharmaceutical resilience
We hope you’ve gained something from our shared perspectives and experiences. Now, we would like to hear from you! Contact us with your resiliency stories—victories and challenges are welcome!
