Redundancy Shouldn't Stop At Manufacturing: Building Resilience Into Your Analytical Testing Strategy

By Patrick Kelley, Senior Director at Pace® Life Sciences

Pharmaceutical supply chain strategies often prioritize manufacturing redundancy, but analytical testing requires the same risk management principles. Key laboratory activities—including release testing, stability programs, raw material analysis, and method validation—directly dictate development and commercial timelines. Relying on a single internal or external facility creates significant vulnerabilities; operational disruptions or sudden demand spikes can easily choke supply chains and delay batch releases.

Establishing qualified third-party testing partners proactively mitigates these risks. Early onboarding allows time for seamless method transfers, quality agreement execution, and facility audits without the pressure of an impending release deadline. Evaluating partners based on scientific expertise, regulatory inspection histories, and scalable capacity transforms analytical testing into a strategic asset. Incorporating flexible, redundant analytical capabilities builds resilience into your CMC framework and keeps programs moving forward.

Read the full article to learn how to build resilience into your analytical testing strategy.