The 1 Thing Drug Development Teams Should Never Do, According To A Formulation Scientist

By Sitav Elturan, Singota Solutions

Imagine this: after months — perhaps years — of meticulous formulation work, your drug product is finally stable. Every analytical study confirms its integrity, and your development team is rightfully proud. You’re ready to move to the next milestone — distribution. But then, the unexpected happens.

Once your sterile injectable product leaves the lab and enters the real world of transportation, things quickly unravel. A sudden temperature excursion, unexpected vibration during transit, or a prolonged delay in shipping — and the stability you worked so hard to achieve is compromised. What was once a pristine, high-quality drug product now faces questions about efficacy, safety, and viability.

This isn’t a dramatic exaggeration; it’s a reality that many pharmaceutical teams face when transportation testing is overlooked or underestimated. While formulation development and stability studies are vital, they don’t tell the full story of how a product will perform under real-world shipping conditions. The physical and environmental stresses encountered during transportation can cause degradation, aggregation, or other irreversible quality issues, especially for sensitive injectable products.

Transportation testing bridges this critical gap by simulating the challenges a drug product may encounter during distribution. It allows teams to identify vulnerabilities early, make necessary packaging or formulation adjustments, and ensure the drug arrives at its destination as intended — safe, stable, and effective.

In this article, we’ll examine why transportation testing is an essential component of drug development, explore the risks of skipping this step, and outline how proactive planning can safeguard your product and protect your investment as it moves through the final stages of the pipeline.