Flexible Facility Design For Multi-Product Manufacturing Of Advanced Therapies

By Emily Moran, Vice President, Vector Manufacturing The Center for Breakthrough Medicines

Cell and gene therapies represent an emerging paradigm, and the future of advanced therapies.

The FDA expects that by 2025 it will issue upwards of 200 investigational new drug (IND) applications for advanced therapies per year, with approval of up to 20 such treatments. This unprecedented growth comes with unique challenges for advanced therapy developers and manufacturers, which often center around the three essentials of quality, speed and innovation.

Although contract development and manufacturing organizations (CDMOs) need to establish technical and regulatory competence to succeed in this competitive market, this article will focus less on unit operations and cGMPs than on critical principles that benefit all end users, large and small, from developers with established platform processes to sponsors and CDMOs already involved in the large-scale manufacture of advanced therapies.

The design of a multi-product facility for advanced therapies begins with an assessment of goals and capabilities. Cell and gene therapies are still in their infancy from an industrialization standpoint, and the facilities commissioned today will almost certainly not support future needs.