Why Analytical Integration Matters: Evaluating The Impact Of In-House Testing Strategies

By Kaden Moore, Quality Control Manager, August Bioservices

Analytical testing is one of the critical steps to delivering a safe and efficacious drug to patients and ensuring compliance with regulators. All sponsors must provide testing data that verifies purity, potency, identity, and stability, and is compliant with FDA, ICH, and other relevant regulatory guidelines. However, there are different pathways to securing that data and establishing a scalable testing approach. As therapeutics and sterile injectables grow increasingly complex, designing a streamlined analytical testing strategy is essential.

There are two standard approaches to gathering analytical data. The first is conducting all or most testing at a CDMO with in-house equipment, and the second is transporting product samples to a variety of different analytical testing vendors. Though no program is one-size-fits-all, an integrated, in-house strategy yields a number of advantages in terms of speed, quality oversight, and program confidence. Download the full article to explore the key benefits of analytical integration on your drug program.