Qualification Considerations For A "Factory-in-a-Box"

By Moria Feighery-Ross and Wai Wong, Pharmatech Associates

The cell therapy market is rapidly expanding into a multibillion-dollar industry, but its production is cost-prohibitive due to the limited manufacturing space and number of personnel required, while capacity is not easily scalable and is limited by processing time.

A “factory-in-a-box” encloses the manufacturing of a product or process in an easily transportable container that requires minimal utility and environmental support. These boxes are designed to replicate the manufacturing process that normally occupies large, controlled manufacturing spaces and requires a number of personnel to support each step of production. Where these modular factories are utilized, manufacturing capacity is limited only by the floor space to house them, which translates to reduced capital investment for scaling up and no lost time to construction. With a “factory-in-a-box,” a dramatic increase in throughput of products fabricated in these systems can be expected to have significant impact on manufacturing capacity.