How To Structure An Analytical Services Partnership From Pre IND Through Commercial For ADCs

By Junhua Zhu and Brent Kennedy, Catalent

Antibody–drug conjugates (ADCs) are designed for precision, but their behavior is inherently complex because the antibody, linker, and cytotoxic payload each introduce distinct sources of variability. As a result, success depends less on the design of the molecule itself and more on how well that complexity is understood and controlled over time. This makes analytical strategy a central driver of program quality rather than a supporting function, with early decisions shaping downstream risk.

In early development, superficial characterization can mask important issues such as drug-to-antibody ratio distribution, aggregation tendencies, and linker stability under stress conditions. These gaps often remain hidden until later stages, when they become more difficult and costly to resolve. As programs progress toward IND and beyond, analytical methods must shift from exploratory tools to robust control mechanisms capable of consistently monitoring critical quality attributes and impurity profiles.

Because ADC development is typically distributed across multiple sites and functions, analytical continuity is essential. Fragmented methods, inconsistent reference standards, or incomplete validation can disrupt data integration and slow regulatory progress. A unified analytical framework helps ensure that insights generated early are carried through into stability, release testing, and submission readiness.