Responding to a Changing Drug Product Global Supply Chain

Of the many lessons learned during the pandemic, one overriding realization was that utilization of the primary, single-location manufacturing site, although the simplest and potentially most cost-effective strategy, can have significant consequences to the availability of critical life-saving biologics and vaccines. This scenario not only applies to drug product but also to drug substance and the wide range of raw materials used throughout the manufacturing supply chain.

Thus, the need for ongoing production from multiple drug substance (DS) and drug product (DP) manufacturing sites around the globe as a risk mitigation approach, to ensure that the supply of biologics and vaccines is provided in a reproducible, reliable, timely and cost-effective manner, is becoming a necessary operational strategy. Regional manufacturing can be efficient and cost-effective when factoring in tariffs, currency fluctuations, taxes, shipping and other logistics costs and even more critically opportunity costs for supply delays. In addition, regional production may result in shorter delivery times and reduced logistical issues and can act to simplify regulatory compliance issues from a Chemistry, Manufacturing and Controls (CMC) perspective. Coupling DS supply with DP manufacturing on a regional basis helps reduce risks even further for all the reasons previously described.

In this article we address the benefits of a regional manufacturing strategy and how WuXi Biologics, as a leading Contract Research, Development and Manufacturing Organization (CRDMO) understands these concerns and is working to address the regional manufacturing issue by implementing its’ “Global Dual Sourcing” supply chain by offering multiple manufacturing sites around the world to its clients. A case study is provided demonstrating how the company’s Leverkusen, Germany site responded to an urgent need for vaccine manufacture during the pandemic to provide over 10 million doses to multiple countries around the globe.