Biopharma Supply Chain Considerations 2021

Before COVID-19 asked us to drop everything and reallocate so much of the biopharma industry's collective attention, fast-approaching requirements of the Drug Supply Chain Security Act (DSCSA) were already placing stress on biopharma supply chain professionals. Notably, biopharmas were busy working to meet the Act's upcoming aggregation requirement, which goes into effect in a little more than two years and calls for a process of creating hierarchical relationships between unique identifiers assigned to packaging containers. It's all part of the November 27, 2023 interoperability timeline, which calls for the entire supply chain (including manufacturers, repackagers, distributors, and dispensers) to demonstrate the unit-level traceability and aggregation requirements mandated by the Act.

Then, along came a global pandemic, giving rise to the urgent need to distribute myriad biologic therapies and vaccines to billions of people 'round the globe via plane, train, and automobile at temperatures varying from that of your kitchen freezer to -70 degrees Celsius. As that worldwide initiative continues to play out and consume supply chain resources, the DSCSA requirement remains. To help biopharma supply chain pros juggle these equally high priorities, we've assembled a collection of columns on these supply chain considerations, authored by independent experts on the topics at hand. We trust you'll find their guidance valuable.