Discussions are widespread about the paradigm shift in the manufacturing site design and flexibility needs of the biopharmaceutical industry.1, 2, 3 The motivations behind these facility organization changes are manifold — for instance, new drug developments, higher expression rates, and changes in process technologies, especially the implementation of single-use systems. In addition, the transformation of treatment to more individualized therapies raises different aseptic processing standards and logistics concerns. Last but not least, there are purely economic reasons for reducing the cost of goods sold.
These, and other, factors are driving a new focus on capacity and process utilization, on facility flexibilities and robust containment options respectively. Ultimately, we are witnessing a shift from large-scale, single product-dedicated brick-and-mortar facilities to multipurpose, versatile ones. Successful facility layouts may also be copied in a cloning approach, to rapidly establish sites in multiple regions of the world.
The shift in facility design requirements resulted in the development of modular, or building block, facility design. Often, though, the term “modular design” is interchangeably used with “flexible facility”, which requires reevaluation, as flexibility may be interpreted in different ways. The article will review when a facility should be described as modular or flexible, or as modular and flexible.