Higher volumetric productivity is contributing to smaller scale
manufacturing. In addition, noted Whitford, volume demand is
decreasing, with emerging products such as personalized
medicines with companion diagnostics targeted to screened
populations, and cancer vaccines generally required in
substantially smaller amounts. Another trend described by
Whitford is “scaling out” instead of scaling up, also known as
distributed manufacturing. Instead of running one 10,000 L
batch, a company might opt to run five 2,000 L reactors in
parallel. Among values inherent in this flexibility, this
minimizes the potential loss if one batch were to become
contaminated or unusable for some other reason. Single-use
systems also simplify geographic distribution of manufacturing
capacity. To duplicate a facility in another location would
require only purchase of the same devices and transfer of the
process, whether to an adjacent building or another country.
Manufacturers of single-use devices are pursuing R&D to create
new, cle