The potency assay for a typical biologic is usually the most complex assay in the release and stability specification. Potency methods should be designed to be as simple as possible to still reflect the mechanism of action (MOA) as is required in the regulations.

Differing bioanalytical method validation and sample analysis requirements among global health authorities have challenged the drug development process, causing inefficiencies and uncertainty. In 2010, regional scientific associations began collaborating in earnest to discuss the challenges created by country-to-country differences.