Advanced Therapy Drug Manufacturers' Checklist For Cleanroom Project Success

By Grant Merrill

We are in the midst of a next-generation scientific revolution in personalized therapeutic medicine, however, the design of manufacturing infrastructure continues to follow an outdated playbook. Current advances in cell, gene and tissue therapies require a rethinking of how—and where—cleanroom manufacturing facilities could be built enabling more options for sponsor process control.

Cell, gene and tissue therapies have transformed medicine, showing meaningful efficacy in treating—or even curing—diseases once thought intractable. Also known as Advanced Therapy Medicinal Products (ATMP), these new treatments represent a significant medical advancement based on the knowledge gained from the human genome. ATMP is only now emerging from the “early days” of this field, and the scalability of these techniques continue to offer challenges to the design of manufacturing facilities.

In particular, manufacturers are pioneering new pathways to create cleanroom facilities that combine both advanced science and manual dependent processes. In this article, we take a look at lessons learned from more than a decade’s experience in building ATMP cleanrooms in order to help manufacturers chart their roadmap for success. This article shares what factors are central to successful entry into commercialization of new therapeutic production capital projects.