From Preclinical To Commercialization: A CRDO Path To Faster Biologic Development

Dr. Ivonne Stelzl, Business Development Manager and Dr. Matthias Lucke, Director Business Development

Biologic drug development increasingly relies on specialized expertise, and this article highlights how a contract research and development organization (CRDO) model offers a more effective path from preclinical work to commercial readiness. Traditional one‑stop‑shop CDMOs have expanded their services over the past two decades, but their broad scope often lacks the deep scientific capabilities required for complex formulation challenges, orthogonal analytics, and detailed molecular characterization. These gaps can slow development or result in avoidable technical risks.

The CRDO model provides a science‑first alternative by concentrating on drug product development and advanced analytics. This focus ensures a deeper understanding of a molecule’s behavior, stability, and manufacturability—capabilities that are essential for navigating the intricacies of biologic programs. Rather than handling all stages internally, CRDOs build alliances with specialized partners in drug substance manufacturing, fill‑finish operations, and packaging. This structure allows each development stage to be managed by the most qualified experts while ensuring streamlined communication, smooth technology transfer, and reduced development risk.

Through well‑coordinated collaboration and a tailored, data‑driven approach, the CRDO model shortens timelines, improves decision‑making, and provides biologics developers with a more flexible, scientifically rigorous pathway from early development to commercialization.