Manufacturing and facility challenges for advanced therapy medicinal product (ATMP) companies are similar to but more complex than those encountered by companies that produce traditional biopharmaceuticals such as vaccines, monoclonal antibodies (mAbs), and other therapeutic proteins.

Project timelines are short, production technologies are new and evolving, and clinical demands change rapidly. Increasing competition for contract manufacturing organizations (CMOs) requires reserving capacity far in advance, which in most cases will not offer the agility needed by developers of advanced therapy medicinal products–many of which are vying to be the first to launch a product for the same indication.