The Challenges of Packing, Shipping, Storing, and Distributing Highly Sensitive Drugs

By Leah Tufts and Leroy Anderson, Bellwyck Pharma Services

Highly sensitive drugs are a growing sector of the clinical trial environment and require specialized environmental controls, elevated shipping provisions, and customized label identification. They are especially at-risk during transport, and the first real test of their stability is during the journey to clinical trial sites. As we look for solutions to reduce risks associated with these products, special planning and care is required. This article outlines key supply chain planning considerations for highly sensitive drugs and provides guidance to prevent losing valuable time and money.

Highly sensitive drugs, early in their development cycle, may not have ample stability data to support their journey to trial sites without temperature controls. Because of this, proper planning is required to create contingencies and mitigate supply chain risks to ensure that products are within acceptable temperature ranges throughout the entire supply chain. Without proper supply chain planning, highly sensitive drugs can be compromised, even completely lost, costing a company valuable time and money compared to a well-managed clinical trial.