Navigating the Complexities of Advanced Therapeutic Medicinal Products: The Critical Role of Specialized CDMOs

The landscape of pharmaceutical development is rapidly evolving, with advanced therapeutic medicinal products (ATMPs), which include gene therapies, cell therapies, and tissue-engineered products, at the forefront of this transformation.

As of April 2023, a total of 25 ATMPs were granted marketing authorization in the EU. In the United States, there are currently 34 FDA-approved cell or gene therapies. The development pipeline for ATMPs is robust, with over 2,200 clinical trials being conducted globally, including 216 in Phase III. This indicates a significant number of ATMPs are on the horizon, poised to transform the therapeutic landscape.

These innovative therapies offer unprecedented potential for treating a range of diseases, many of which were previously deemed untreatable. However, the journey from development to patient delivery is fraught with complexities, particularly in the realms of labeling, packaging and distribution.

This article delves into the intricacies of working with ATMPs and underscores the benefits of outsourcing these critical tasks to an experienced Contract Development and Manufacturing Organization (CDMO) with innovative processes, facilities and highly specialized, skilled teams.